Anal CancerPhase 3KANALRADNCT06207981
Phase III Study Evaluating Induction Chemotherapy Followed by Chemoradiotherapy Compared to Standard Chemoradiotherapy for Locally Advanced SCCA
A Phase 3 study testing induction chemotherapy (mDCF), Concomitant chemotherapy (Capecitabin + Mitomycin-C) and radiotherapy in people with Anal Cancer, run by Federation Francophone de Cancerologie Digestive at 114 sites in 2 countries.
Trial summary
Squamous cell carcinoma of the anus is still a rare disease but its incidence increases mostly due to its association with human papillomavirus (HPV). When localized, the standard treatment combines radiotherapy and chemotherapy with 5FU and mitomycin-C. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anal Cancer
- What is being tested?
- induction chemotherapy (mDCF), Concomitant chemotherapy (Capecitabin + Mitomycin-C) and radiotherapy
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 310 participants
- Where
- 114 sitesin 2 countries
- Study dates
- 26 Feb 2024to 1 Feb 2030
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Anal Squamous cell carcinoma histologically proven
- Locally advanced tumors without metastases
- Stage T3 or T4
- Stage N1 (a, b or c) - any T (T1 to T4)
- Age ≥18 and ≤ 75 or > 75 in case of score G8 > 14 or favourable oncogeriatric assessment
- Measurable tumor on MRI
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- Able to receive chemotherapy and radiotherapy
- No major comorbidity that may preclude the delivery of treatment
- Adequate hematologic function: absolute neutrophil count ≥ 1500/mm3, platelet count ≥ 100 000/mm3, Hb ≥ 9g/dl
- Adequate renal function: creatinine clearance (according to MDRD formula) ≥ 60 ml/min
- Adequate hepatic function: AST and ALT ≤ 2.5 × Upper Limit of Normal and total bilirubin ≤ 1.5 × ULN
- WHO performance status < 2
- Signature of informed consent
- A negative pregnancy test for inclusion in the study for all female patients of child-bearing potential. In case of a "urine pregnancy test", it must be a highly sensitive urine pregnancy test, in accordance with the recommendations of the CTFG regarding pregnancy risk management (Recommendations related to contraception and pregnancy testing in clinical trials)
- Female patients postmenopausal for at least one year or surgically infertile for at least 6 weeks, or effective contraception for male (until 6 months after the end of the investigational treatments) and female patients of childbearing potential (until 7.5 months after the end of treatment with cisplatine)
- Patient to be covered by a regimen of French Social Security system.
Who cannot join
- Presence of metastases
- Stage T1N0 or T2N0
- History of pelvic radiotherapy
- Complete or partial Dihydropyrimidine dehydrogenase (DPD) deficiency (uracilemia ≥ 16 ng/mL)
- Positive HIV serology with CD4 < 400 / mm3
- Presence of neuropathy > grade 2 according to NCIC-CTC 4.0
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- Contraindication for chemotherapy and/or radiotherapy
- Concomitant treatment with CYP3A4 inhibitors or inducers
- Symptomatic cardiac or coronary insufficiency
- Progressive active infection or any unbalanced progressive severe condition in the last 6 months
- No contraindication to MRI imaging
- Other cancer treated within the last 3 years except in situ cervical carcinoma or basocellular/ spinocellular carcinoma or any other carcinoma in situ considered as cured
- breastfeeding woman.
- Persons deprived of liberty or under guardianship or incapable of giving consent
- Any psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol or follow-up schedule.
- Live attenuated vaccines within 4 weeks before randomization 17. In case of hearing problem 18. In case of combination with phenytoin with prophylactic aim 19. In case of recent or concomitant treatment brivudine
Trial locations and contacts
114 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
114 sites in 2 countries
France112 sites, 112 recruiting
- Not yet recruiting
AGEN-Cromg
Agen
Olivier BERNARD, +335 53 69 20 13, o.bernard@cromg.fr
- Not yet recruiting
Clinique Calabet
Agen
Olivier BERNARD
- Not yet recruiting
AIX EN PROVENCE CH Pays d'Aix
Aix-en-Provence
Caroline DANISI, +334 42 33 50 64, cdanisi@ch-aix.fr
- Not yet recruiting
Amiens - Clinique de L'Europe
Amiens
Faycal HOCINE, +333 60 12 53 26, faycal.hocine@cthe-amiens.fr
- Not yet recruiting
ANTONY Hôpital Privé
Antony
Anne THIROT-BIDAULT, +331 46 74 41 73, a.t.bidault@gmail.com
- Recruiting
Argenteuil - Ch
Argenteuil
Gregory MANUCEAU, +331 34 23 25 21, gregory.manuceau@ch-argenteuil.fr
- Not yet recruiting
ARRAS Les Bonnettes
Arras
Alexandre HENNI, +333 21 2 103 24, alexandre.henni@ichf.fr
- Not yet recruiting
ARRAS Marie Curie
Arras
Alexandre HENNI, +333 21 21 03 24, alexandre.henni@ichf.fr
- Not yet recruiting
AURILLAC-Henri Mondor
Aurillac
Daniela BURLACU, +334 71 46 47 41, d.burlacu@ch-aurillac.fr
- Not yet recruiting
Centre Medico Chirurgical
Aurillac
Madeleine Pasquie
- Recruiting
AUXERRE CH GHT Unyon
Auxerre
Anne-Laure VILLING, +333 86 48 47 42, alvilling@ch-auxerre.fr
- Recruiting
Avignon Icap
Avignon
Laurent MINEUR, +334 90 27 61 81, l.mineur@isc84.org
- Recruiting
Avranches - Hopital Prive de La Baie
Avranches
Victor PERNIN, +332 23 79 50 60, v.pernin@centredelabaie.fr
- Not yet recruiting
Bayonne- Clinique Belharra
Bayonne
Marjorie FAURE, +335 36 28 90 02, marjorie.faure@copb.eu
- Not yet recruiting
BEAUVAIS-Simone Veil
Beauvais
Hanifa AMMARGUELLAT, +333 44 11 22 16, h.ammarguellat@ch-beauvais.fr
- Recruiting
Besancon Chu
Besançon
Christophe BORG, +333 81 66 92 21, christophe.borg@efs.sante.fr
- Not yet recruiting
Beuvry - Clinique Ambroise Pare
Beuvry
Laurent BASSON, 0321616682, laurent.basson@ichf.fr
- Not yet recruiting
Beuvry Pierre Curie
Beuvry
Laurent BASSON, laurent.basson@ichf.fr
- Recruiting
Bordeaux - Privé - Tivoli
Bordeaux
REGNAULT DE LA MOTHE, +335 56 39 47 28, paulineregnault@hotmail.fr
- Recruiting
BORDEAUX-Institut Bergonié
Bordeaux
MILHADE, +335 56 33 44 49, n.milhade@bordeaux.unicancer.fr
- Recruiting
Institut Bergonié
Bordeaux
Nicolas MILHADE, 05 56 33 44 49, n.milhade@bordeaux.unicancer.fr
- Recruiting
Pessac - Chu -Haut Leveque
Bordeaux
Véronique Vendrely, mdphd, 05 57 62 33 13, veronique.vendrely@chu-bordeaux.fr
- Not yet recruiting
Ch Duchenne
Boulogne-sur-Mer
Vincent BOURGEOIS, +333 21 99 32 57, v.bourgeois@ch-boulogne.fr
- Recruiting
BREST Pasteur Lanroze
Brest
Véronique JESTIN LE TALLEC, +332 98 31 32 00, veronique.jestin-letallec@oncologie-brest.fr
- Recruiting
CAEN Polyclinique du Parc
Caen
Maud VILLEMIN, +332 31 52 20 00, m.villemin@ccpc-tubiana.fr
- Recruiting
CAEN-François Baclesse
Caen
Aurélie PARZY, +332 31 45 50 16, a.parzy@baclesse.unicancer.fr
- Not yet recruiting
Cahors -Ch
Cahors
Slim LASSOUED, +335 65 20 54 19, slim.lassoued@ght-lot.fr
- Not yet recruiting
Caluire Et Cuire-Infirmerie Protestante
Caluire-et-Cuire
Johannes HARTWIG, +334 72 00 71 67, johannes.hartwig@infirmerie-protestante.com
- Recruiting
Chalon-Sur-Saone Hopital Sainte Marie
Chalon-sur-Saône
Jean-Florian GUION, +333 85 48 89 89, jeanflo@hotmail.com
- Recruiting
Chambery Ch
Chambéry
Laetitia LECOQ, +334 79 96 50 87, laetitia.lecoq@ch-metropole-savoie.fr
- Recruiting
Chambray Les Tours-Roc37
Chambray-lès-Tours
Pierre COMBE, +332 47 60 25 74, p.combe@cort37.fr
- Not yet recruiting
Centre Jean Perrin
Clermont-Ferrand
Juliette MOREAU
- Not yet recruiting
Chu Estaing
Clermont-Ferrand
Marine JARY, +334 73 75 05 08, mjary@chu-clermontferrand.fr
- Not yet recruiting
Centre de Radiothérapie Savoie Nord
Contamine-sur-Arve
Claire TRICAUD
- Not yet recruiting
Clinique de Flandre
Coudekerque-Branche
Jean-Philippe WAGNER
- Recruiting
CRETEIL-Henri Mondor CHU
Créteil
Yazid BELKACEMI, +331 49 81 45 22, yazid.belkacemi@hmn.aphp.fr
- Not yet recruiting
DAX CH
Dax
Nicolas PONTIER, +335 58 91 48 31, PONTIERN@ch-dax.fr
- Recruiting
DECHY-Léonard de Vinci
Dechy
Alexandre ESCANDE, +333 27 08 60 60, aescande@clinique-psv.fr
- Recruiting
Dijon - Chu François Mitterrand
Dijon
Imène MARREF, 03.80.29.37.50, imene.marref@chu-dijon.fr
- Not yet recruiting
DIJON-GF Leclerc
Dijon
Sarah GHIRARDI, +333 80 73 75 18, sghirardi@cgfl.fr
- Recruiting
DIJON-Institut de Cancérologie de Bourgogne
Dijon
Ariane DARUT-JOUVE, +333 80 67 30 10, adarut-jouve@icb-cancer.fr
- Not yet recruiting
Ghm Grenoble - Institut Daniel Hollard
Grenoble
Helene FLESCH, +334 76 70 73 33, helene.flesch@avec.fr
- Recruiting
LA ROCHE-SUR-YON CHD Vendée
La Roche-sur-Yon
Lucile BAUGUION, +332 51 44 61 68, lucile.bauguion@chd-vendee.fr
- Not yet recruiting
Guillaume Le Conquérant
Le Havre
Laurent Martin, 02 35 13 66 13, l.martin@cglc.fr
- Not yet recruiting
LE HAVRE-l'Estuaire
Le Havre
Helen HOMOKOS, +332 76 89 97 84, h.homokos@ramsaygds.fr
- Recruiting
LE MANS-CH Victor Hugo
Le Mans
Thibaut LIZEE, +332 43 29 79 08, essaislizee@ilcgroupe.fr
- Not yet recruiting
Lille - Hopital Prive La Louviere
Lille
Olivier ROMANO, +333 28 53 53 53, romanoolivier@yahoo.fr
- Not yet recruiting
Limoges - Polyclinique Francois Chenieux
Limoges
Xavier ZASADNY, +335 55 45 48 00, xz@imagemed-87.com
- Not yet recruiting
Limoges-Chu Dupuytren
Limoges
Frédéric THUILLIER, +335 55 05 63 96, frederic.thuillier@chu-limoges.fr
- Not yet recruiting
LONGJUMEAU-GHNE Hôpital d'Antony
Longjumeau
Samy LOUAFI, +331 64 54 29 41, samy.louafi@gmail.com
- Recruiting
Lorient - Groupe Hospitalier Bretagne Sud - Site Du Scorff
Lorient
Edwina GIRARD, +332 97 06 96 95, e.girard@ghbs.bzh
- Recruiting
LYON Jean Mermoz
Lyon
Jerome DESRAME, +334 37 53 87 26, jerome.desrame@orange.fr
- Not yet recruiting
LYON- Léon Bérard
Lyon
Jessica SERRAND, 04 74 09 97 60, jessica.serrand@lyon.unicancer.fr
- Not yet recruiting
LYON-Saint Joseph
Lyon
Marc O'BRIEN, 04 78 61 62 76, mobrien@saintjosephsaintluc.fr
- Recruiting
MARSEILLE Institut Paoli Calmettes
Marseille
Marguerite TYRAN, 06 66 74 81 85, tyranm@ipc.unicancer.fr
- Recruiting
MARSEILLE Saint-Joseph
Marseille
Hervé PERRIER, +334 91 80 82 11, hperrier@hopital-saint-joseph.fr
- Recruiting
MARSEILLE-Hôpital la Timone
Marseille
Laetitia DAHAN, +334 91 38 60 23, laetitia.dahan@ap-hm.fr
- Not yet recruiting
Montbeliard Ch
Montbéliard
Christophe BORG, +333 81 98 87 75, christophe.borg@efs.sante.fr
- Recruiting
MONTPELLIER-ICM Val d'Aurelle
Montpellier
Claire LEMANSKI, +334 67 61 37 52, Claire.Lemanski@icm.unicancer.fr
- Recruiting
Mougins Cac
Mougins
Angélique SAINT, +334 92 92 44 63, a.saint@cac-mougins.fr
- Recruiting
MULHOUSE CH Emile Muller
Mulhouse
Stéphanie HUSSON-WETZEL, +333 89 64 70 49, husson-wetzels@ghrmsa.fr
- Not yet recruiting
Nantes - Hopital Prive Du Confluent
Nantes
Benjamin LINOT, +332 28 27 22 38, benjamin.linot@groupeconfluent.fr
- Not yet recruiting
NEUILLY-SUR-SEINE GH Hartmann
Neuilly-sur-Seine
Jean-Michel VANNETZEL, +331 47 59 57 80, dr.vannetzel@gmail.com
- Recruiting
NICE-Antoine LACASSAGNE
Nice
Ludovic EVESQUE, +334 92 03 13 52, ludovic.evesque@nice.unicancer.fr
- Not yet recruiting
Nimes Chu
Nîmes
Charles DEBRIGODE, +334 66 68 31 63, charles.debrigode@chu-nimes.fr
- Not yet recruiting
Centre Hospitalier
Niort
Audrey PERRET, 05.49.78.24.82, audrey.perret@ch-niort.fr
- Not yet recruiting
ORLEANS Centre Hospitalier Régional
Orléans
Remy LELOUP, +332 38 51 45 15, remy.leloup@chr-orleans.fr
- Recruiting
OSNY-CHP Sainte-Marie
Osny
Fabien MIGNOT, +331 30 38 58 05, f.mignot@crom95.com
- Not yet recruiting
Paris - Ap-Hp - Hopital Tenon
Paris
Florence HUGUET, +331 56 01 83 22, florence.huguet@aphp.fr
- Not yet recruiting
Paris - Chu -Saint Louis Aphp
Paris
Laurent QUERO, +331 42 49 90 34, laurent.quero@aphp.fr
- Recruiting
PARIS GHD Croix Saint-Simon
Paris
Olivier DUBREUIL, +33144742839, odubreuil@hopital-dcss.org
- Recruiting
PARIS Hopital Europeen Georges-Pompidou
Paris
Widad LAHLOU, +33156 09 50 64, widad.lahlou@aphp.fr
- Recruiting
PARIS Institut Curie
Paris
Romain SEBAN, +331 44 32 41 95, romain.seban@curie.fr
- Recruiting
PARIS-Saint Joseph
Paris
Nabil BABA-HAMED, 01 44 12 68 88, nbaba-hamed@hpsj.fr
- Not yet recruiting
Pau Groupe de Radiotherapie Et D'Oncologie Des Pyrenees
Pau
Olivier GILLIOT, +335 59 92 72 75, ogilliot@gmail.com
- Recruiting
PERIGUEUX-Hôpital Francheville
Périgueux
Laurent CANY, +335 53 06 41 40, l.cany@oncoradio24.com
- Not yet recruiting
Plerin Hopital Prive Des Cotes D'Armor - Centre Cario
Plérin
Jérôme MARTIN-BABAU, +332 96 75 22 16, j.martin@cario-sante.fr
- Recruiting
POITIERS- CHU la Miletrie
Poitiers
David TOUGERON, +335 49 44 37 51, david.tougeron@chu-poitiers.fr
- Not yet recruiting
PRINGY-Annecy Genevois CH
Pringy
Mathieu BACONNIER, +334 50 63 68 55, mbaconnier@ch-annecygenevois.fr
- Recruiting
REIMS-CHU Robert Debré
Reims
Olivier BOUCHÉ, +333 26 78 31 13, obouche@chu-reims.fr
- Recruiting
REIMS-Jean Godinot
Reims
Damien BOTSEN, +333 26 50 44 03, damien.botsen@reims.unicancer.fr
- Not yet recruiting
Rennes - Centre Eugene Marquis
Rennes
Aurélien BRIENS, +332 99 25 30 20, a.briens@rennes.unicancer.fr
- Not yet recruiting
Rennes Chu Pontchaillou
Rennes
Astrid LIEVRE, +332 99 28 99 72, astrid.lievre@chu-rennes.fr
- Not yet recruiting
RODEZ CH
Rodez
Mihaela BAIES, +335 65 55 26 10, m.baies@ch-rodez.fr
- Not yet recruiting
Hopitaux Prives Rouennais - Clinique Mathilde
Rouen
Romain KOKORIAN, +332 32 81 15 48, romkokorian@hotmail.fr
- Recruiting
ROUEN-Frédéric Joliot
Rouen
Lucie LEBRET, +332 32 76 40 76, lucie.lebret@centrefredericjoliot.fr
- Not yet recruiting
Saint Denis Ch
Saint-Denis
Gaetan DES GUETZ, +335 55 05 55 55, gaetan.desguetz@ch-stdenis.fr
- Not yet recruiting
CHU
Saint-Etienne
Nicolas VIAL, 0477917102, nicolas.vial@chu-st-etienne.fr
- Recruiting
Saint Herblain Ico
Saint-Herblain
Valentine GUIMAS, +332 40 67 99 16, Valentine.Guimas@ico.unicancer.fr
- Not yet recruiting
SAINT NAZAIRE CM l'Estuaire
Saint-Nazaire
Marie-Gabrielle SALIOU, +332 72 27 54 02, marie.saliou@hospigrandouest.fr
- Not yet recruiting
Centre Hospitalier
Saint-Quentin
Innocenti DADAMESSI, 03 23 06 72 12, i.dadamessi@ch-stquentin.fr
- Not yet recruiting
SARCELLES - Institut de Cancérologie Paris Nord
Sarcelles
Anne LARROUY, +331 39 90 49 55, a.larrouy@icpn.care
- Not yet recruiting
Clinique Cote d'Emeraude
St-Malo
Fabrice Ramiandrisoa
- Not yet recruiting
Saint Malo Ch
St-Malo
Romain DESGRIPPES, +332 99 21 21 55, r.desgrippes@ch-stmalo.fr
- Recruiting
Strasbourg Icans
Strasbourg
Meher BEN ABDELGHANI, +333 88 25 24 85, m.ben-abdelghani@icans.eu
- Recruiting
STRASBOURG Sainte Anne
Strasbourg
Louis-Marie DOURTHE, +333 88 45 37 50, lm.dourthe@solcrr.org
- Not yet recruiting
Tarbes - Lourdes - Ch
Tarbes
Lulia PRIPON, +335 62 54 61 45, ipripon@ch-tarbes-vic.fr
- Recruiting
Tarbes - Polyclinique de L'Ormeau
Tarbes
Guillaume PEYRAGA, +335 62 93 59 29, dr.peyraga@grop65.fr
- Not yet recruiting
Thonon Les Bains - Hopitaux Du Leman
Thonon-les-Bains
Fanny POMMERET, +334 50 83 21 25, f-pommeret@ch-hopitauxduleman.fr
- Not yet recruiting
Centre de Radiothérapie Saint-Louis
Toulon
Romain DEJEAN, 0494244050, Romain.dejean@croix-rouge.fr
- Not yet recruiting
TOULON-Sainte Anne
Toulon
Caroline PRIEUX-KLOTZ, +334 83 16 25 19, caroline.klotz@intradef.gouv.fr
- Not yet recruiting
Toulouse - Oncopole Institut Claudius Regaud
Toulouse
Audrey KELLER, +335 31 15 54 10, keller.audrey@iuct-oncopole.fr
- Recruiting
Toulouse Chu - Hopital Rangueil
Toulouse
Rosine GUIMBAUD, +335 61 32 21 42, guimbaud.r@chu-toulouse.fr
- Recruiting
TOULOUSE-Clinique Pasteur
Toulouse
Mathilde MARTINEZ, 05 67 20 44 01, m.martinez@clinique-pasteur.com
- Recruiting
TOURS CHU Trousseau
Tours
Elise DOUARD-TOURNET, +332 47 47 82 61, e.tournet@chu-tours.fr
- Not yet recruiting
Valence - Centre Marie Curie
Valence
Emilie BONNET, 0321616682, dr.bonnet@cmc-valence.org
- Not yet recruiting
Valence Ch
Valence
Céline MONTUCLARD, +334 75 62 57 43, cmontuclard@ch-valence.fr
- Not yet recruiting
VALENCE Drôme-Ardèche
Valence
Agnès PELAQUIER, +334 75 78 24 66, agnes.pelaquier@orange.fr
- Recruiting
Vandoeuvre Les Nancy-Ic Lorraine
Vandœuvre-lès-Nancy
Jean-François PY, +333 83 59 83 49, jf.py@nancy.unicancer.fr
- Recruiting
VILLEJUIF Gustave Roussy
Villejuif
Jérôme DURAND-LABRUNIE, 06 75 37 97 62, Jerome.DURAND-LABRUNIE@gustaveroussy.fr [Affiliation]
- Not yet recruiting
Centre de Radiothérapie Bayard
Villeurbanne
Victor Passerat, 0481655296, v.passerat@free.fr
- Not yet recruiting
Villeurbanne Medipole Hopital Mutualiste Lyon
Villeurbanne
Marie-Anne GUILLAUMOT, +334.87.65.02.90, ma.guillaumot@gelmad.fr
Reunion2 sites, 2 recruiting
- Not yet recruiting
Reunion - Chu Sud
Saint-Pierre
Shakeel SUMODHEE, +332 62 35 92 01, shakeel.sumodhee@chu-reunion.fr
- Not yet recruiting
La Reunion - Clinique Prive Sainte Clotilde
Sainte-Clotilde
Freddy RANDRIANASOLO, +332 62 48 20 40, freddy.randrianasolo@clinifutur.net
About this study
Official title: PRODIGE 85- KANALRAD : Prospective Randomized Phase III Study Evaluating Induction Chemotherapy (Modified DCF 4 Cycles) Followed by Chemoradiotherapy Compared to Standard Chemoradiotherapy for Locally Advanced Anal Squamous Cell Carcinoma (T3-4 or N1a, b or c)
Squamous cell carcinoma of the anus is still a rare disease but its incidence increases mostly due to its association with human papillomavirus (HPV). When localized, the standard treatment combines radiotherapy and chemotherapy with 5FU and mitomycin-C. Chemoradiotherapy (CRT) achieves a good outcome for early stage tumors (T1-T2 tumors without nodal involvement), but more advanced tumors (T3-T4 or N1) are associated with a dismal prognosis. About 35 % of such patients relapse within two years after the end of treatment Recently, for metastatic or recurrent tumors after chemoradiotherapy, a chemotherapy combining docetaxel, cisplatin and 5FU (modified DCF protocol) has given very good results with a median overall survival of 39.2 months in 2 French trials (Epitopes HPV01 and 02). Our idea is to propose a new strategy , associating this chemotherapy (mDCF) followed by chemoradiotherapy to improve efficacy of the treatment for patients with locally advanced anal cancers. To this end, The principal investigator propose a national, multicenter, randomized phase 3 clinical trial to compare induction chemotherapy with mDCF followed by chemoradiotherapy versus standard chemoradiotherapy for locally advanced anal canal cancer.
the efficacy of the treatment will be evaluated by comparing disease-related event-free survival at 2 years according to the type of treatment. Other endpoints will also be evaluated such as overall survival and colostomy-free survival, treatment tolerability, response rate and quality of life.
This trial will be offered to patients over 18 years of age with locally advanced anal cancer without metastasis (T3-4 or N1). It is open to patients over 75 years of age subject to a favorable evaluation by an oncogeriatrician. It is also open to immunocompromised patients (HIV+) if their immunity is well controlled under antiretroviral treatment.The standard chemoradiotherapy treatment consists of 33 sessions of radiation, one session per day from Monday to Friday for 6.5 weeks. It is combined with chemotherapy that includes mitomycin during the first and fifth weeks of radiation therapy, as well as capecitabine that are taken on the days of radiation therapy.In the experimental arm, this chemoradiotherapy treatment is preceded by 4 sessions of mDCF chemotherapy performed every 2 weeks.After treatment, patients are followed up at 8 weeks, then every 4 months for 2 years, and every 6 months for the last year with clinical examination and imaging (CT and MRI).
- Conditions
- Anal Cancer
- Being tested
- induction chemotherapy (mDCF), Concomitant chemotherapy (Capecitabin + Mitomycin-C), radiotherapy
- Medical subject headings
- Anus Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
induction chemotherapy (mDCF)Drug
Induction chemotherapy consists of mDCF administered every 2 weeks:
- Docetaxel (40 mg/m², day 1),
- Cisplatin (40 mg/m², day 1)
- 5-FU (1200 mg/m²/day IV for 2 days)
Concomitant chemotherapy (Capecitabin + Mitomycin-C)Drug
Concomitant Chemotherapy consists of Mitomycin-C (10 mg/m2 intravenous infusion at D1 and D29) and Capecitabine (1650 mg/m²/day divided in two oral intakes 825 mg/m² twice a day, five days a week). Patients should be counseled to only take capecitabine on the days when radiotherapy is being given
radiotherapyRadiation
Radiotherapy consists of conformational intensity-modulated external irradiation with simultaneous integrated boost (IMRT-SIB) with 2 level of dose (30 sessions)
- 49.5 Gy (5 x 1.65 Gy/week) to the pelvis
- 60 Gy (5 x 2 Gy /week) to the primary tumor and initially involved nodes
| Study group | Role | What they receive |
|---|---|---|
| Control arm | Active comparator | Pelvic chemoradiotherapy Radiotherapy consists of conformational intensity-modulated external irradiation with simultaneous integrated boost (IMRT-SIB) with 2 level of dose (30 sessions)
* 49.5 Gy (5 x 1.65 Gy/week) to the pelvis
* 60 Gy (5 x 2 Gy /week) to the primary tumor and initially involved nodes
Concomitant Chemotherapy consists of Mitomycin-C (10 mg/m2 intravenous infusion at D1 and D29) and Capecitabine (1650 mg/m²/day divided in two oral intakes 825 mg/m² twice a day, five days a week). Patients should be counseled to only take capecitabine on the days when radiotherapy is being given Receives: Drug: Concomitant chemotherapy (Capecitabin + Mitomycin-C); Radiation: radiotherapy |
| Exeprimental arm | Experimental | Induction chemotherapy with mDCF (4 cycles) followed by pelvic chemoradiotherapy
Induction chemotherapy consists of mDCF administered every 2 weeks:
* Docetaxel (40 mg/m², day 1),
* Cisplatin (40 mg/m², day 1)
* 5-FU (1200 mg/m²/day IV for 2 days) Chemoradiotherapy is the same as described above in control arm Receives: Drug: induction chemotherapy (mDCF); Drug: Concomitant chemotherapy (Capecitabin + Mitomycin-C); Radiation: radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease-related event free survival (DREFS) at 2 years
DREFS will be compared between the two arms . An event is defined as :progression, residual tumor at 6 months requiring APR, recurrence (local or metastatic) or death
Measured: 2 years after last patient completed treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2024
- Study start26 Feb 2024
- Primary completion1 Feb 2029 (estimated)
- Study completion1 Feb 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 310 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federation Francophone de Cancerologie Digestive
- Sponsor type
- University, hospital or other
- Collaborators
- Fondation ARCAD
- Responsible party
- Sponsor
- Investigators
- Veronique Vendrely, Md-pHD, Principal investigator, University Hospital, Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06207981
- Sponsor's protocol ID
- Prodige 85 KANALRAD
- Acronym
- KANALRAD
- Status last verified
- Feb 2025
- First submitted
- 5 Jan 2024
- Last updated
- 2 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PRODIGE 85- KANALRAD : Prospective Randomized Phase III Study Evaluating Induction Chemotherapy (Modified DCF 4 Cycles) Followed by Chemoradiotherapy Compared to Standard Chemoradiotherapy for Locally Advanced Anal Squamous Cell Carcinoma (T3-4 or N1a, b or c)
- ClinicalTrials.gov ID
- NCT06207981
- Acronym / sponsor ID
- KANALRAD / Prodige 85 KANALRAD
- Conditions
- Anal Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 310 participants (estimated)
- Lead sponsor
- Federation Francophone de Cancerologie DigestiveUniversity, hospital or other
- Collaborators
- Fondation ARCAD
- Study start
- 26 Feb 2024 (actual)
- Primary completion
- 1 Feb 2029 (estimated)
- Study completion
- 1 Feb 2030 (estimated)
- First posted
- 17 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Squamous cell carcinoma of the anus is still a rare disease but its incidence increases mostly due to its association with human papillomavirus (HPV). When localized, the standard treatment combines radiotherapy and chemotherapy with 5FU and mitomycin-C. Chemoradiotherapy (CRT) achieves a good outcome for early stage tumors (T1-T2 tumors without nodal involvement), but more advanced tumors (T3-T4 or N1) are associated with a dismal prognosis. About 35 % of such patients relapse within two years after the end of treatment Recently, for metastatic or recurrent tumors after chemoradiotherapy, a chemotherapy combining docetaxel, cisplatin and 5FU (modified DCF protocol) has given very good results with a median overall survival of 39.2 months in 2 French trials (Epitopes HPV01 and 02). Our idea is to propose a new strategy , associating this chemotherapy (mDCF) followed by chemoradiotherapy to improve efficacy of the treatment for patients with locally advanced anal cancers. To this end, The principal investigator propose a national, multicenter, randomized phase 3 clinical trial to compare induction chemotherapy with mDCF followed by chemoradiotherapy versus standard chemoradiotherapy for locally advanced anal canal cancer.
the efficacy of the treatment will be evaluated by comparing disease-related event-free survival at 2 years according to the type of treatment. Other endpoints will also be evaluated such as overall survival and colostomy-free survival, treatment tolerability, response rate and quality of life.
This trial will be offered to patients over 18 years of age with locally advanced anal cancer without metastasis (T3-4 or N1). It is open to patients over 75 years of age subject to a favorable evaluation by an oncogeriatrician. It is also open to immunocompromised patients (HIV+) if their immunity is well controlled under antiretroviral treatment.The standard chemoradiotherapy treatment consists of 33 sessions of radiation, one session per day from Monday to Friday for 6.5 weeks. It is combined with chemotherapy that includes mitomycin during the first and fifth weeks of radiation therapy, as well as capecitabine that are taken on the days of radiation therapy.In the experimental arm, this chemoradiotherapy treatment is preceded by 4 sessions of mDCF chemotherapy performed every 2 weeks.After treatment, patients are followed up at 8 weeks, then every 4 months for 2 years, and every 6 months for the last year with clinical examination and imaging (CT and MRI).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control arm | Active comparator | Drug: Concomitant chemotherapy (Capecitabin + Mitomycin-C), Radiation: radiotherapyPelvic chemoradiotherapy Radiotherapy consists of conformational intensity-modulated external irradiation with simultaneous integrated boost (IMRT-SIB) with 2 level of dose (30 sessions) * 49.5 Gy (5 x 1.65 Gy/week) to the pelvis * 60 Gy (5 x 2 Gy /week) to the primary tumor and initially involved nodes Concomitant Chemotherapy consists of Mitomycin-C (10 mg/m2 intravenous infusion at D1 and D29) and Capecitabine (1650 mg/m²/day divided in two oral intakes 825 mg/m² twice a day, five days a week). Patients should be counseled to only take capecitabine on the days when radiotherapy is being given |
| Exeprimental arm | Experimental | Drug: induction chemotherapy (mDCF), Drug: Concomitant chemotherapy (Capecitabin + Mitomycin-C), Radiation: radiotherapyInduction chemotherapy with mDCF (4 cycles) followed by pelvic chemoradiotherapy Induction chemotherapy consists of mDCF administered every 2 weeks: * Docetaxel (40 mg/m², day 1), * Cisplatin (40 mg/m², day 1) * 5-FU (1200 mg/m²/day IV for 2 days) Chemoradiotherapy is the same as described above in control arm |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Anal Squamous cell carcinoma histologically proven
- Locally advanced tumors without metastases
- Age ≥18 and ≤ 75 or > 75 in case of score G8 > 14 or favourable oncogeriatric assessment
- Measurable tumor on MRI
- Able to receive chemotherapy and radiotherapy
Key exclusion criteria (16 listed)
- Presence of metastases
- Stage T1N0 or T2N0
- History of pelvic radiotherapy
- Complete or partial Dihydropyrimidine dehydrogenase (DPD) deficiency (uracilemia ≥ 16 ng/mL)
- Positive HIV serology with CD4 < 400 / mm3
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| induction chemotherapy (mDCF)Induction chemotherapy consists of mDCF administered every 2 weeks: * Docetaxel (40 mg/m², day 1), * Cisplatin (40 mg/m², day 1) * 5-FU (1200 mg/m²/day IV for 2 days) | Drug | Exeprimental arm |
| Concomitant chemotherapy (Capecitabin + Mitomycin-C)Concomitant Chemotherapy consists of Mitomycin-C (10 mg/m2 intravenous infusion at D1 and D29) and Capecitabine (1650 mg/m²/day divided in two oral intakes 825 mg/m² twice a day, five days a week). Patients should be counseled to only take capecitabine on the days when radiotherapy is being given | Drug | Control arm, Exeprimental arm |
| radiotherapyRadiotherapy consists of conformational intensity-modulated external irradiation with simultaneous integrated boost (IMRT-SIB) with 2 level of dose (30 sessions) * 49.5 Gy (5 x 1.65 Gy/week) to the pelvis * 60 Gy (5 x 2 Gy /week) to the primary tumor and initially involved nodes | Radiation | Control arm, Exeprimental arm |
Primary outcome
Disease-related event free survival (DREFS) at 2 years
Time frame: 2 years after last patient completed treatment
DREFS will be compared between the two arms . An event is defined as :progression, residual tumor at 6 months requiring APR, recurrence (local or metastatic) or death
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2025.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Veronique Vendrely, Md-pHD principal investigator
University Hospital, Bordeaux
114 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing induction chemotherapy (mDCF), Concomitant chemotherapy (Capecitabin + Mitomycin-C) and radiotherapy in people with Anal Cancer, run by Federation Francophone de Cancerologie Digestive at 114 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 114 sites in France, Reunion. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Veronique Vendrely, Md-pHD (+33 380393483, prodige85.kanalrad@ffcd.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease-related event free survival (DREFS) at 2 years (time frame: 2 years after last patient completed treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2025.