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Esophageal CancerPhase 3NCT00047112

Surgery With or Without Radiation Therapy and Chemotherapy in Treating Patients With Esophageal Cancer

A Phase 3 study testing cisplatin, fluorouracil and conventional surgery in people with Esophageal Cancer, run by Federation Francophone de Cancerologie Digestive at 73 sites in 4 countries.

Completed

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

Official record
Search all trials

Trial summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Giving combination chemotherapy with radiation therapy before surgery may shrink the tumor so it can be removed during surgery. Read more about this study

Who is it for?
Ages Up to 74 years
Conditions the study is for
Esophageal Cancer
What is being tested?
cisplatin, fluorouracil and conventional surgery
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
195 participants
Where
73 sitesin 4 countries
Study dates
May 2002to Sep 2010
Phase
Phase 3
Are there results?
None posted in the registry

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 Up to 74 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

DISEASE CHARACTERISTICS:

  • Diagnosis of stage I or II thoracic esophageal cancer
  • Tumor no greater than 3 cm with no invasion of mediastinal structures with or without extension to the lymph nodes (T1-2, N0-1, M0) OR
  • Tumor greater than 3 cm with no invasion of mediastinal structures and no adenopathy greater than 1 cm (T3, N0, M0)
  • Epidermoid carcinoma or adenocarcinoma
  • Previously untreated
  • Deemed resectable with curative intent
  • No carcinoma in situ
  • No small cell anaplastic carcinoma (i.e., chromogranin negative)
  • No small cell neuroendocrine carcinoma (i.e., chromogranin positive)
  • No multifocal esophageal carcinoma (i.e., 2 or more distinct lesions 5 or more cm apart)
  • No involvement of the pharyngoesophageal junction and the first 4 cm of the esophagus (i.e., where the proximal edge of the tumor is less than 19 cm from the dental arch)
  • No evidence of extension to the tracheobronchial tree at endoscopy, ultrasound, or CT scan (simple compression allowed)
  • No signs of mediastinal involvement on CT scan
  • No palpable subclavicular lymph nodes or involvement after cytology needle aspiration
  • No lymph nodes from the origin of the celiac greater than 1 cm on CT scan
  • Perigastric lymph nodes far from the celiac trunk and deemed resectable allowed unless tumor is more than 30 mm on CT scan

PATIENT CHARACTERISTICS:

Age

  • Under 75

Performance status

  • WHO 0-1

Life expectancy

  • Not specified

Hematopoietic

  • Granulocyte count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3

Hepatic

  • SGOT/SGPT ratio no greater than 1
  • Albumin at least 35 g/L
  • Total protein greater than 80%
  • No liver cirrhosis with previous failure
  • No ascites
  • No jaundice
  • No rupture of varicose esophageal veins
  • No presence of varicose esophageal veins

Renal

  • Creatinine no greater than 1.25 times normal

Cardiovascular

  • Arterial O_2 greater than 60 mm Hg
  • Arterial CO_2 no greater than 45 mm Hg
  • No myocardial infarction within the past 6 months
  • No progressive coronary artery disease grade 2 or greater
  • No recent left ventricular failure
  • No arterial disease stage II-IV

Pulmonary

  • FEV_1 greater than 1 L/sec

Other

  • Able to receive either study treatment
  • No recurrent paralysis
  • No weight loss greater than 10% from baseline
  • No other prior or concurrent malignancy except basal cell skin cancer or carcinoma in situ of the cervix
  • Not pregnant
  • Fertile patients must use effective contraception during and for 3 months after completion of chemotherapy

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • Not specified

Endocrine therapy

  • Not specified

Radiotherapy

  • Not specified

Surgery

  • Not specified

Trial locations and contacts

73 sites in 4 countries.

73 sites in 4 countries

France63 sites

  • Centre Hospitalier Regional et Universitaire d'Angers

    Angers, 49033

  • Centre Paul Papin

    Angers, 49036

  • Study site

    Arras, 62000

  • CHR de Besancon - Hopital Jean Minjoz

    Besançon, 25030

  • CHU Ambroise Pare

    Boulogne-Billancourt, F-92104

  • Centre Hospitalier Docteur Duchenne

    Boulogne-sur-Mer, 62200

  • C.H. Bourg En Bresse

    Bourg-en-Bresse, 01012

  • Centre Hospitalier de Bourgoin - Jallieu

    Bourgoin, 38300

  • CHU Brest - Hopital De La Cavale Blanche

    Brest, 29200

  • Centre Hospitalier General

    Brivé, 19101

  • CHU de Caen

    Caen, 14033

  • Clinique Sainte Marie

    Chalon-sur-Saône, 71100

  • CHR Clermont Ferrand, Hotel dieu

    Clermont-Ferrand, 63003

  • Hopital Beaujon

    Clichy, 92118

  • Hopital Louis Pasteur

    Colmar, 68024

  • Centre Hospitalier de Lagny

    Compiègne, 60321

  • Centre Hospitalier Universitaire de Dijon

    Dijon, 21034

  • Centre Hospitalier De Dunkerque - CHD

    Dunkirk, 59240

  • Study site

    Évreux, 27000

  • Centre Hospitalier Departemental

    La Roche-sur-Yon, F-85025

  • Hopital Andre Mignot

    Le Chesnay, 78157

  • Centre Jean Bernard

    Le Mans, 72000

  • Hopital Robert Boulin

    Libourne, 33500

  • Polyclinique Du Bois

    Lille, 59000

  • Centre Oscar Lambret

    Lille, 59020

  • Centre Hospitalier Regional et Universitaire de Lille

    Lille, 59037

  • Hopital de la Croix Rousse

    Lyon, 69317

  • Institut J. Paoli and I. Calmettes

    Marseille, 13273

  • Assistance Publique Hopitaux de Marseille Hopitaux Sud

    Marseille, 13274

  • CHU de la Timone

    Marseille, 13385

  • Centre Gray

    Maubeuge, 59600

  • Centre Hospitalier de Meaux

    Meaux, 77104

  • Hopital Notre-Dame de Bon Secours

    Metz, 57038

  • CH Meulan

    Meulan-en-Yvelines, 78250

  • Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle

    Montpellier, 34298

  • Centre Hospitalier

    Mulhouse, 68070

  • CHR Hotel Dieu

    Nantes, 44093

  • Hopital de l'Archet

    Nice, F-06202

  • CHR D'Orleans - Hopital de la Source

    Orléans, 45067

  • Hopital Saint Antoine

    Paris, 75012

  • Hopital Europeen Georges Pompidou

    Paris, 75015

  • Centre Hospitalier Lyon Sud

    Pierre-Bénite, 69495

  • Hopital Jean Bernard

    Poitiers, 86021

  • Centre Hospitalier De Pontivy

    Pontivy, 56300

  • Institut Jean Godinot

    Reims, 51056

  • Centre Hospitalier Universitaire

    Reims, 51092

  • Centre Eugene Marquis

    Rennes, 35042

  • Centre Rene Huguenin

    Saint-Cloud, 92210

  • Centre Hospitalier D'Agen

    Saint-Esprit, 47000

  • Centre Hospitalier Intercommunal de Poissy

    Saint-Germain-en-Laye, 78104

  • Centre Joliot Curie Des Docteurs Jean-Christophe Chardon Jacques Hernandez Et Laurent Gasnault

    Saint-Martin-Boulogne, 62280

  • Clinique Sainte Clotilde

    Sainte-Clotilde, 97400

  • C.H. Senlis

    Senlis, 60309

  • Centre Hospitalier General De Saint-Malo

    St-Malo, 35400

  • Centre Paul Strauss

    Strasbourg, 67065

  • Hopitaux Universitaire de Strasbourg

    Strasbourg, 67091

  • Hopital Universitaire Hautepierre

    Strasbourg, 67098

  • CHU de Tours

    Tours, 37044

  • Nouvelle Clinique Generale

    Valence, 26000

  • Centre Hospitalier de Valenciennes

    Valenciennes, 59300

  • CHU de Nancy - Hopitaux de Brabois

    Vandœuvre-lès-Nancy, 54511

  • Centre d'Oncologie Saint-Yves

    Vannes, 56001

  • Institut Gustave Roussy

    Villejuif, F-94805

Other trials in France

Belgium5 sites

  • Institut Jules Bordet

    Brussels, 1000

  • Hopital Universitaire Erasme

    Brussels, 1070

  • Universitair Ziekenhuis Antwerpen

    Edegem, B-2650

  • Universiteit Gent

    Ghent, B-9000

  • CHR - Clinique Saint Joseph - Hopital de Warqueguies

    Mons, B-7000

Other trials in Belgium

Germany4 sites

  • Robert Roessle Comprehensive Cancer Center at University of Berlin - Charite Campus Buch

    Berlin, D-13122

  • Universitaet Erlangen

    Erlangen, D-91054

  • Klinikum der Albert - Ludwigs - Universitaet Freiburg

    Freiburg im Breisgau, D-79106

  • Universitaets-Krankenhaus Eppendorf

    Hamburg, D-20246

Other trials in Germany

Netherlands1 site

  • Academisch Ziekenhuis Maastricht

    Maastricht, 6202 AZ

Other trials in Netherlands

About this study

Official title: Randomized Study of Pre-Operative Radio-Chemotherapy Versus Surgery Alone in Thoracic Esophageal Cancer Deemed to be Resectable

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Giving combination chemotherapy with radiation therapy before surgery may shrink the tumor so it can be removed during surgery. It is not yet known if surgery is more effective with or without radiation therapy and chemotherapy in treating esophageal cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of surgery with or without radiation therapy and chemotherapy in treating patients who have esophageal cancer.

Read the detailed description

OBJECTIVES:

  • Compare the overall survival of patients with resectable thoracic esophageal cancer treated with neoadjuvant radio-chemotherapy and surgery versus surgery alone.
  • Compare the disease-free survival of patients treated with these regimens.
  • Compare the surgical mortality and morbidity of patients treated with these regimens.
  • Compare the resectability of patients treated with these regimens.
  • Determine the validation of new prognostic factors for survival of these patients and/or the efficacy of this neoadjuvant treatment.

OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified according to histology (epidermoid carcinoma vs adenocarcinoma vs undifferentiated carcinoma), stage (I vs IIA vs IIB), tumor location (above the carina vs below the carina), and participating center. Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients undergo radiotherapy daily 5 days a week for 5 weeks. Patients receive fluorouracil IV continuously on days 1-4 and 29-32 and cisplatin IV on days 1 or 2 and 29 or 30 (or a lower dose on days 1-5 and 29-33). Within 4-8 weeks after completion of radio-chemotherapy, patients undergo surgical resection.
  • Arm II: Patients undergo surgical resection. Patients are followed every 4 months for 2 years, every 6 months for 3 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 380 patients (190 per treatment arm) will be accrued for this study within 3 years.

Keywords
adenocarcinoma of the esophagus, squamous cell carcinoma of the esophagus, stage I esophageal cancer, stage II esophageal cancer
Medical subject headings
Esophageal Neoplasms, Adenocarcinoma Of Esophagus, Esophageal Squamous Cell Carcinoma

What participants receive

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

Study groups in NCT00047112
Study groupRoleWhat they receive
CHIMIORADIOTHERAPIE SUIVIE DE CHIRURGIEExperimentalCHIMIORADIOTHERAPIE SUIVIE DE CHIRURGIE
Receives: Drug: cisplatin; Drug: fluorouracil; Procedure: conventional surgery; Procedure: neoadjuvant therapy; Radiation: radiation therapy
CHIRURGIE SEULEActive comparatorCHIRURGIE SEULE
Receives: Procedure: conventional surgery

What is being measured

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

  1. overal survival

    Measured: 2010

Secondary outcomes (1)

  1. recurrence free survival

    Measured: 2010

Timeline

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

  1. First posted27 Jan 2003 (estimated)
  2. Study startMay 2002
  3. Primary completionSep 2010
  4. Study completionSep 2010

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
195 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00047112
Sponsor's protocol ID
CDR0000257600
Other IDs
FFCD-9901, EORTC-22001, EORTC-40001, FRE-FNCLCC-FFCD-9901, FRE-GERCOR-FFCD-9901, SFRO-FFCD-9901, EU-20215
Status last verified
Mar 2020
First submitted
3 Oct 2002
Last updated
30 Mar 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Mariette C, Robb WB, Piessen G. Reply to Letter: "The Role of Surgery for Patients With a Complete Clinical Response After Chemoradiation for Esophageal Cancer". Ann Surg. 2015 Dec;262(6):e101-2. doi: 10.1097/SLA.0000000000000668. No abstract available.

    PubMed 24670853

  • Mariette C, Dahan L, Mornex F, Maillard E, Thomas PA, Meunier B, Boige V, Pezet D, Robb WB, Le Brun-Ly V, Bosset JF, Mabrut JY, Triboulet JP, Bedenne L, Seitz JF. Surgery alone versus chemoradiotherapy followed by surgery for stage I and II esophageal cancer: final analysis of randomized controlled phase III trial FFCD 9901. J Clin Oncol. 2014 Aug 10;32(23):2416-22. doi: 10.1200/JCO.2013.53.6532. Epub 2014 Jun 30.

    PubMed 24982463

  • Robb WB, Dahan L, Mornex F, Maillard E, Thomas PA, Meunier B, Boige V, Pezet D, Le Brun-Ly V, Bosset JF, Mabrut JY, Triboulet JP, Bedenne L, Seitz JF, Mariette C; Federation Francaise de Cancerologie Digestive, Societe Francaise de Radiotherapie Oncologique, Union des Centres de Lutte Contre le Cancer, Groupe Cooperateur Multidisciplinaire en Oncologie, French EsoGAstric Tumour working group, Federation de Recherche En Chirurgie. Impact of neoadjuvant chemoradiation on lymph node status in esophageal cancer: post hoc analysis of a randomized controlled trial. Ann Surg. 2015 May;261(5):902-8. doi: 10.1097/SLA.0000000000000991.

    PubMed 25361220

  • Robb WB, Messager M, Dahan L, Mornex F, Maillard E, D'Journo XB, Triboulet JP, Bedenne L, Seitz JF, Mariette C; Federation Francophone de Cancerologie Digestive; Societe Francaise de Radiotherapie Oncologique; Union des Centres de Lutte Contre le Cancer; Groupe Cooperateur Multidisciplinaire en Oncologie; French EsoGAstric Tumour working group - Federation de Recherche En Chirurgie. Patterns of recurrence in early-stage oesophageal cancer after chemoradiotherapy and surgery compared with surgery alone. Br J Surg. 2016 Jan;103(1):117-25. doi: 10.1002/bjs.9959. Epub 2015 Oct 29.

    PubMed 26511668

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing cisplatin, fluorouracil and conventional surgery in people with Esophageal Cancer, run by Federation Francophone de Cancerologie Digestive at 73 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

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 30 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 73 sites in France, Belgium, Germany, Netherlands. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

overal survival (time frame: 2010). 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 NCT00047112, which also lists 4 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 30 Mar 2020.

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