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Epidermoid CarcinomaPhase 1/2NCT01581840

Radiochemotherapy With Panitumumab in the Localised Epidermoid Carcinoma of the Anus

A Phase 1/2 study testing radiochemotherapy and Panitumumab in people with Epidermoid Carcinoma and Anus, run by Federation Francophone de Cancerologie Digestive at 15 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Treatment is based on radiochemotherapy for locally advanced tumours. The objective of treatment is to provide a cure without resorting to abdominoperineal amputation, while preserving sphincter function. The prognosis is mainly related to tumour size and lymph node invasion. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Epidermoid Carcinoma, Anus
What is being tested?
radiochemotherapy and Panitumumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
45 participants
Where
15 sitesFrance
Study dates
Jan 2016to Feb 2021
Phase
Phase 1/2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

  • Histologically proven epidermoid carcinoma of the anus
  • Locally advanced tumour without metastases
  • Stage T2>3 cm or T3 or T4, irrespective of N
  • Stage N1-N3 irrespective of T stage (T1 to T4)
  • General condition WHO 0-1
  • Life expectancy > 3 months
Show all 11Show fewer
  • Signed informed consent form
  • Age > 18 years
  • Effective contraception in female and/or male patients having reached sexual maturity during treatment and up to 6 months after the end of treatment
  • CD4 > 400 / mm3
  • Measureable tumor on at least one of the following exams : MRI, endoscopic ultrasonography, clinical exam

Who cannot join

  • Presence of metastases
  • Previous anti-EGFR therapy
  • Stage T1N0 or T2 < 3 cm N0
  • History of pelvic radiotherapy
  • At least one of the following laboratory test results: Neutrophils < 1500 /mm3, platelets < 100 000 /mm3, Hb < 9 g/dl, leukocytes < 3000/mm3, blood bilirubin > 1.5 times the upper limit of the normal range, transaminase (ASAT and ALAT) > 2.5 times the upper limit of the normal range, creatinine clearance < 50 mL/min (Cockcroft's formula Appendix x), Mg2+ < the lower limit of the normal range, Ca2+ < the lower limit of the normal range
  • Significant coronary artery disease or myocardial infarction in the past year
Show all 10Show fewer
  • Follow-up not possible due to psychological or geographic reasons
  • History of interstitial pneumonitis or pulmonary fibrosis
  • History of malignant disease in the past five years apart from basocellular skin carcinoma or in situ cervical carcinoma having received adequate treatment
  • Pregnant or breast-feeding women, women of child-bearing potential not having taken a pregnancy test.

Trial locations and contacts

15 sites in 1 country.

15 sites in 1 country

France15 sites

  • Pessac - Hôpital Haut Lévêque

    Bordeaux

  • CH - Hopitaux civils de Colmar

    Colmar

  • Centre d'oncologie et de radiothérapie du Parc

    Dijon

  • Centre Oscar Lambret

    Lille

  • CH - CHBS - Hôpital du Scorff

    Lorient

  • Centre Léon Bérard

    Lyon

  • Institut Régional du Cancer Montpellier

    Montpellier

  • Clinique Privée - Plein Ciel

    Mougins

  • Institut Curie

    Paris

  • Cario - HPCA - Hôpital privé des Côtes D'Armor

    Plérin

  • CH - Annecy Genevois

    Pringy

  • Centre Eugène Marquis

    Rennes

  • Institut Curie

    Saint-Cloud

  • CHU

    Saint-Priest-en-Jarez

  • CAC - Paul Strauss

    Strasbourg

Other trials in France

About this study

Official title: Phase I-II on Radiochemotherapy Combined With Panitumumab in the Treatment of Localised Epidermoid Carcinoma of the Anus

Treatment is based on radiochemotherapy for locally advanced tumours. The objective of treatment is to provide a cure without resorting to abdominoperineal amputation, while preserving sphincter function.

The prognosis is mainly related to tumour size and lymph node invasion. The large majority of patients do not show any spread remote from the tumour at the time of diagnosis (2).

Read more

Recurrences are mainly of a local/regional nature and require abdominoperineal amputation. This type of intervention is not always possible or complete, which then gives rise to the particularly distressing risk of local progression, with survival at 3 years of approximately 30% (3).

It is therefore very important to achieve a complete and permanent tumour response from initial treatment with radiochemotherapy.

Furthermore, the use of an anti-EGFR antibody in combination with exclusive radiotherapy in ENT cancer was able to increase recurrence-free survival and overall survival in these patients. These data are in favour of the use of a combination of chemotherapy and anti-EGFR antibodies in epidermoid cancer of the anus.

Being tested
radiochemotherapy, Panitumumab
Keywords
anus, carcinoma, panitumumab, mitomycine, 5Fu, radiotherapy
Medical subject headings
Carcinoma, Squamous Cell, Carcinoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • radiochemotherapyDrug

    Radiotherapy : PTV1 45 Gy 5 weeks PTV2 20 Gy 2 weeks Chemotherapy : 5Fu (400 to 1000 mg/m²) mitomycin : 10 mg/m²

  • PanitumumabDrug

    3 or 6 mg/kg (according to dose level)

Study groups in NCT01581840
Study groupRoleWhat they receive
5Fu-mitomycine-panitumumab + radiotherapyExperimental5 FU = 400 or 600 or 80 or 1000 mg depending of phase I results, days 1 to 4 weeks 1, 5 and 8 mitomicyne = 10 mg/m² day 1 week 1 and days 1, weeks 5 and 8 Panitumumab = 3 or 6 mg/kg (depending of phase I results) days 1, weeks: 1, 3, 5, 8 and 10
Receives: Drug: radiochemotherapy; Drug: Panitumumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Patients With Complete Response to Treatment

    Complete response was defined by the complete disappearance of the tumor on proctological examination and morphological examinations (MRI and/or echo-endoscopy) and the absence of secondary lesion appearance. The responses were validated by an independent committee:

    • In the event of a discrepancy between the investigator and the independent committee, the independent committee's response was used;
    • in case of uncertainty of the investigator on the response, the committee decided on the response in view of the clinical and morphological data; This endpoint was assessed 8 weeks after the end of treatment (week 15). A patient who died (regardless of cause) was considered a failure for the primary endpoint

    Measured: 8 weeks evaluations after the end of the treatment by radiochemotherapy

Secondary outcomes (4)

  1. Percentage of Patients With Complete Response to Treatment

    Complete response was defined by the complete disappearance of the tumor on proctological examination and morphological examinations (MRI and/or echo-endoscopy) and the absence of secondary lesion appearance according to the investigator's opinion

    Measured: 16 weeks after the end of the treatement by radiotherapy

  2. 3 Years Colostomy-free Survival (CFS)

    It was defined as the time from inclusion to the date of colostomy or death (from any cause). Patients alive without colostomy were censored at date of last news. If a patient had a shunt colostomy and continuity wasrestored, the patient was counted among the patients without a colostomy.

    Measured: At 3 years after inclusion

  3. Recurrence-free Survival (RFS) at 3 Years

    It was defined as the time from inclusion to the date of first recurrence (local, regional, metastatic and second anal cancer) or death. Patients alive without recurrence were censored at date of last news.

    Measured: At 3 years after inclusion

  4. Overall Survival (OS) at 12 Months

    The percentage was evaluated at 12 months using the Kaplan Meier estimation.

    In the safety part all the death collected during the study will be reported.

    Measured: At 12 months after inclusion

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Apr 2012 (estimated)
  2. Study startJan 2016
  3. Primary completionSep 2018
  4. Study completionFeb 2021

Resources

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 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
45 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01581840
Sponsor's protocol ID
FFCD 0904
Status last verified
Jun 2024
First submitted
6 Apr 2012
Last updated
1 Jul 2024
Data monitoring committee
Yes

Publications

  • Vendrely V, Lemanski C, Gnep K, Barbier E, Hajbi FE, Lledo G, Dahan L, Terrebonne E, Manfredi S, Mirabel X, Mammar V, Cowen D, Lepage C, Aparicio T; for FFCD investigators/Collaborators. Anti-epidermal growth factor receptor therapy in combination with chemoradiotherapy for the treatment of locally advanced anal canal carcinoma: Results of a phase I dose-escalation study with panitumumab (FFCD 0904). Radiother Oncol. 2019 Nov;140:84-89. doi: 10.1016/j.radonc.2019.05.018. Epub 2019 Jun 8.

    PubMed 31185328

  • Vendrely V, Ronchin P, Minsat M, Le Malicot K, Lemanski C, Mirabel X, Etienne PL, Lievre A, Darut-Jouve A, de la Fouchardiere C, Giraud N, Breysacher G, Argo-Leignel D, Thimonnier E, Magne N, Abdelghani MB, Lepage C, Aparicio T; for FFCD investigators/Collaborators. Panitumumab in combination with chemoradiotherapy for the treatment of locally-advanced anal canal carcinoma: Results of the FFCD 0904 phase II trial. Radiother Oncol. 2023 Sep;186:109742. doi: 10.1016/j.radonc.2023.109742. Epub 2023 Jun 12.

    PubMed 37315583

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing radiochemotherapy and Panitumumab in people with Epidermoid Carcinoma and Anus, run by Federation Francophone de Cancerologie Digestive at 15 sites in France.

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 11 inclusion and 10 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: finished, as of the sponsor's last update on 1 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 sites in France. 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 combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 1 Jul 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Patients With Complete Response to Treatment (time frame: 8 weeks evaluations after the end of the treatment by radiochemotherapy). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01581840, which also lists 2 linked publications.

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 1 Jul 2024.

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