Status:
COMPLETED
Radiation Therapy and Combination Chemotherapy With or Without Surgery in Treating Patients With Locally Advanced Esophageal Cancer That Can Be Removed By Surgery
Lead Sponsor:
Federation Francophone de Cancerologie Digestive
Conditions:
Esophageal Cancer
Eligibility:
All Genders
Phase:
PHASE3
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, eith...
Detailed Description
OBJECTIVES: * Compare the survival of patients with locally advanced esophageal cancer treated with neoadjuvant radiotherapy and chemotherapy comprising fluorouracil and cisplatin followed by surgery...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2007
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00416858
End Date
April 1 2007
Last Update
March 4 2014
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