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| ID | Type | Description | Link |
|---|---|---|---|
| FFCD-9102 | |||
| EU-20539 | |||
| ESSAI-FFCD-9102 |
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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.
OBJECTIVES:
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to gender, histology (epidermoid vs glandular), response to induction therapy (complete vs partial), and tumor differentiation (little differentiated vs undifferentiated/good vs moderately differentiated).
Quality of life is assessed at baseline, after treatment on arms I or II, and then every 2 months (arm I) or every 6 months (arm II) thereafter.
After completion of study therapy, patients are followed periodically.
PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cisplatin | Drug | |||
| fluorouracil | Drug | |||
| adjuvant therapy | Procedure | |||
| conventional surgery | Procedure | |||
| neoadjuvant therapy | Procedure | |||
| radiation therapy | Radiation |
DISEASE CHARACTERISTICS:
Histologically confirmed epidermoid or glandular cancer of the esophagus meeting the following criteria:
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)
No contraindication to radiotherapy
No recurring left paralysis
PRIOR CONCURRENT THERAPY:
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| Name | Affiliation | Role |
|---|---|---|
| Laurent Bedenne, MD | Federation Francophone de Cancerologie Digestive | Study Chair |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18372134 | Result | Burtin 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. | |
| 17401004 |
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| Result |
| Bedenne 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. |
| 17971585 | Result | Crehange 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. |
| 16524973 | Result | Bonnetain 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. |
| ID | Term |
|---|---|
| D004938 | Esophageal Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D004066 | Digestive System Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
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| ID | Term |
|---|---|
| D002945 | Cisplatin |
| D005472 | Fluorouracil |
| D017024 | Chemotherapy, Adjuvant |
| D020360 | Neoadjuvant Therapy |
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D003131 | Combined Modality Therapy |
| D013812 | Therapeutics |
| D004358 | Drug Therapy |
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