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.
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
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
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
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
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.
- Conditions
- Esophageal Cancer
- Being tested
- cisplatin, fluorouracil, conventional surgery, neoadjuvant therapy, radiation therapy
- 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.
cisplatinDrug
fluorouracilDrug
conventional surgeryProcedure or surgery
neoadjuvant therapyProcedure or surgery
radiation therapyRadiation
| Study group | Role | What they receive |
|---|---|---|
| CHIMIORADIOTHERAPIE SUIVIE DE CHIRURGIE | Experimental | CHIMIORADIOTHERAPIE SUIVIE DE CHIRURGIE Receives: Drug: cisplatin; Drug: fluorouracil; Procedure: conventional surgery; Procedure: neoadjuvant therapy; Radiation: radiation therapy |
| CHIRURGIE SEULE | Active comparator | CHIRURGIE SEULE Receives: Procedure: conventional surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
overal survival
Measured: 2010
Secondary outcomes (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.
- First posted27 Jan 2003 (estimated)
- Study startMay 2002
- Primary completionSep 2010
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Esophageal 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
- 195 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federation Francophone de Cancerologie Digestive
- Sponsor type
- University, hospital or other
- Collaborators
- GERCOR - Multidisciplinary Oncology Cooperative Group, European Organisation for Research and Treatment of Cancer - EORTC, UNICANCER, Societe Francaise de Radiotherapie Oncologique
- Responsible party
- Sponsor
- Investigators
- J. P. Triboulet, Study chair, Centre Hospitalier Regional et Universitaire de LilleJean-Francois Seitz, MD, Study chair, Institut Paoli-Calmettes
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 24670853Mariette 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 24982463Robb 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 25361220Robb 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