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

• Status: Completed
• Trial end date: 2007-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Federation Francophone de Cancerologie Digestive
• Treatments: Fluorouracil

Criteria

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