Phase II Trial of Preoperative Combined Modality Therapy for Esophageal Carcinoma: Cisplatin-Irinotecan Followed by Radiation Therapy With Concurrent Cisplatin and Irinotecan.

Part of paid clinical trials in New York, New York.

Sponsor: Memorial Sloan Kettering Cancer Center
Study ID: NCT00590031
Phase: PHASE2
Status: Completed

Conditions

Esophageal Carcinoma

Eligibility Criteria

Sex: ALL
Age: 18 Years - N/A
Healthy Volunteers: Not accepted

Interventions

Cisplatin — DRUG
pts will receive weekly cisplatin 30mg/m2 after hydration on weeks 8,9,11 and 12
Irinotecan — DRUG
Irinotecan will be given 65 mg/m2
External Beam Radiation Therapy — RADIATION
will be delivered with multiple (\>2) field techniques using mega-voltage radiation therapy. pts will receive 50.4 Gy and will be treated over a 6 week period.

Study Details

Patients with surgically resectable T1N1M0 or T2-4N any M0 esophageal carcinoma will receive six weeks of induction chemotherapy with weekly irinotecan and cisplatin given weeks 1, 2, 4 and 5. Patients will then receive weekly irinotecan, cisplatin, and concurrent radiotherapy with chemotherapy given once weekly, weeks 8,9,11 and 12 during the six weeks of radiotherapy. Patients will be referred for surgery 4-8 weeks after completion of chemoradiotherapy.