Clinical trial · Interventional
Radiation Therapy and Combination Chemotherapy With or Without Surgery in Treating Patients With Locally Advanced Esophageal Cancer That Can Be Removed By Surgery
Randomized Study of Adjuvant Radiochemotherapy After Surgery Versus Radiochemotherapy Alone in Patients With Locally Advanced Esophageal Cancer
- 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: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as fluorouracil and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving radiation therapy together with combination chemotherapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving these treatments after surgery may kill any tumor cells that remain. PURPOSE: This randomized phase III trial is studying radiation therapy together with combination chemotherapy to see how well they work with or without surgery in treating patients with locally advanced esophageal cancer that can be removed by surgery.
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 (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| adjuvant therapy | Procedure | — | UNRESOLVED |
| cisplatin | Drug | Cisplatin | ALIAS |
| conventional surgery | Procedure | — | UNRESOLVED |
| fluorouracil | Drug | Fluorouracil | ALIAS |
| neoadjuvant therapy | Procedure | — | UNRESOLVED |
| radiation therapy | Radiation | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed epidermoid or glandular cancer of the esophagus meeting the following criteria: * Tumor volume with or without mediastinal adenopathy, celiac, or subclavicular involvement * T3, N0-N1 disease * Tumor extends into fifth stratum by endosonographic scan * Resectable disease (palliative or curative) * No cervical tumor * No T1, T2, or T4 tumors * No tracheo-esophageal fistula or tracheal invasion * No gastric cardia cancer by gastroscopy * No visceral (e.g., lung, bone, brain, liver), ganglion, or clavicular metastases PATIENT CHARACTERISTICS: * WHO performance status 0-2 * Creatinine normal * WBC ≥ 3,000/mm\^3 * Neutrophil count ≥ 1,500/mm\^3 * Platelet count ≥ 100,000/mm\^3 * Transaminases ≥ 60% * Bilirubin ≤ 2.0 mg/dL * No cirrhosis * DLCO ≥ 1.5 L with or without hypoxemia at rest * No progressive coronary insufficiency * Weight loss ≤ 15% * No other malignancy in the past 2 years * Must be able to maintain sufficient enteral nutrition (2,000 calories/day) * Laser photodestruction, dilation, or gastric balloon allowed * No contraindication to radiotherapy * No recurring left paralysis PRIOR CONCURRENT THERAPY: * No concurrent nephrotoxic or myelotoxic drugs
References
Publications (4)
- RESULTBurtin P, Bouche O, Giovannini M, Pelletier M, Conroy T, Ruget O, Arsene D, Milan C, Bedenne L. Endoscopic ultrasonography is an independent predictive factor of prognosis in locally advanced esophageal cancer. Results from the randomized FFCD 9102 study from the Federation Francophone de Cancerologie Digestive. Gastroenterol Clin Biol. 2008 Mar;32(3):213-20. doi: 10.1016/j.gcb.2007.12.026. Epub 2008 Mar 26. PMID 18372134
- RESULTBedenne L, Michel P, Bouche O, Milan C, Mariette C, Conroy T, Pezet D, Roullet B, Seitz JF, Herr JP, Paillot B, Arveux P, Bonnetain F, Binquet C. Chemoradiation followed by surgery compared with chemoradiation alone in squamous cancer of the esophagus: FFCD 9102. J Clin Oncol. 2007 Apr 1;25(10):1160-8. doi: 10.1200/JCO.2005.04.7118. PMID 17401004
- RESULTCrehange G, Maingon P, Peignaux K, N'guyen TD, Mirabel X, Marchal C, Verrelle P, Roullet B, Bonnetain F, Bedenne L; Federation Francophone de Cancerologie Digestive 9102. Phase III trial of protracted compared with split-course chemoradiation for esophageal carcinoma: Federation Francophone de Cancerologie Digestive 9102. J Clin Oncol. 2007 Nov 1;25(31):4895-901. doi: 10.1200/JCO.2007.12.3471. PMID 17971585
- RESULTBonnetain F, Bouche O, Michel P, Mariette C, Conroy T, Pezet D, Roullet B, Seitz JF, Paillot B, Arveux P, Milan C, Bedenne L. A comparative longitudinal quality of life study using the Spitzer quality of life index in a randomized multicenter phase III trial (FFCD 9102): chemoradiation followed by surgery compared with chemoradiation alone in locally advanced squamous resectable thoracic esophageal cancer. Ann Oncol. 2006 May;17(5):827-34. doi: 10.1093/annonc/mdl033. Epub 2006 Mar 8. PMID 16524973