Radiation Therapy and Combination Chemotherapy With or Without Surgery in Treating Patients With Locally Advanced Esophageal Cancer That Can Be Removed By Surgery

NCT00416858 | Completed Phase 3

• 4 other identifiers: CDR0000453783FFCD-9102EU-20539ESSAI-FFCD-9102
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Esophageal Cancer

Keywords

stage III esophageal cancer

Interventions

cisplatin DRUG

fluorouracil DRUG

adjuvant therapy PROCEDURE

conventional surgery PROCEDURE

neoadjuvant therapy PROCEDURE

radiation therapy RADIATION

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Federation Francophone de Cancerologie Digestive: lead

Related Publications (4)

• 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.

  PMID: 18372134 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.

  PMID: 17401004 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.

  PMID: 17971585 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.

  PMID: 16524973 RESULT

MeSH Terms

Conditions

Esophageal Neoplasms

Interventions

Cisplatin; Fluorouracil; Chemotherapy, Adjuvant; Neoadjuvant Therapy; Radiotherapy

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Combined Modality Therapy; Therapeutics; Drug Therapy

Study Officials

• Laurent Bedenne, MD

  Federation Francophone de Cancerologie Digestive

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Purpose: TREATMENT
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 27, 2006
• First Posted: December 28, 2006
• Primary Completion: April 1, 2007
• Study Completion: April 1, 2007
• Last Updated: March 4, 2014

Record last verified: 2007-04