Clinical trial · Interventional
Surgery With or Without Radiation Therapy and Chemotherapy in Treating Patients With Esophageal Cancer
Randomized Study of Pre-Operative Radio-Chemotherapy Versus Surgery Alone in Thoracic Esophageal Cancer Deemed to be Resectable
NCT00047112CI-TRIAL-00044308completedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Esophageal Cancer | Malignant Esophageal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cisplatin | Drug | Cisplatin | ALIAS |
| conventional surgery | Procedure | — | UNRESOLVED |
| fluorouracil | Drug | Fluorouracil | ALIAS |
| neoadjuvant therapy | Procedure | — | UNRESOLVED |
| radiation therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- CHIMIORADIOTHERAPIE SUIVIE DE CHIRURGIE
- description
- CHIMIORADIOTHERAPIE SUIVIE DE CHIRURGIE
- interventionNames
- Drug: cisplatin
- Drug: fluorouracil
- Procedure: conventional surgery
- Procedure: neoadjuvant therapy
- Radiation: radiation therapy
- type
- ACTIVE_COMPARATOR
- label
- CHIRURGIE SEULE
- description
- CHIRURGIE SEULE
- interventionNames
- Procedure: conventional surgery
Primary outcomes (1)
- measure
- overal survival
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 74 Years
Show eligibility criteria text
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
References
Publications (4)
- BACKGROUNDMariette 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. PMID 24670853
- RESULTMariette 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. PMID 24982463
- RESULTRobb 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. PMID 25361220
- DERIVEDRobb 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. PMID 26511668