Neoplasms

All Conditions

Digestive System Diseases

Rare Diseases

Carcinoma

Esophageal Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Gastrointestinal Neoplasms

Digestive System Neoplasms

Head and Neck Neoplasms

Gastrointestinal Diseases

Esophageal Diseases

Esophageal Cancer

Antineoplastic Agents

All Drugs and Chemicals

Irinotecan

Cisplatin

Topoisomerase I Inhibitors

Enzyme Inhibitors

External Beam Radiation Therapy, Cisplatin, Irinotecan

pts will receive weekly cisplatin 30mg/m2 after hydration on weeks 8,9,11 and 12

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.

External Beam Radiation Therapy

David Ilson, MD

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.

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

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

Pathological information will be available for all patients who receive surgery. If a patient is deemed unresectable based on clinical and radiological examination after the therapy, that patient will be counted as non-responder. The best overall response is the best response recorded from the start of treatment until disease progression (taking as reference for progressive disease the smallest measurements recorded since the treatment started). The subject's best response assignment will depend on the achievement of both measurement and confirmation criteria. We will also estimate the pathological complete response rates separately for each of these tumor types. Survival and disease-free survival will be estimated using Kaplan-Meier method. With an accrual rate of 3 patients a month, we expect the study to be completed in 18 months.

Memorial Sloan Kettering Cancer Center

The trial will be a phase II, single institution trial of preoperative therapy with irinotecan, cisplatin, and concurrent radiotherapy in surgically resectable esophageal cancer. The primary endpoint is the pathologic complete response rate to preoperative therapy, and a sample size of 50 patients will characterize this response rate +/- 13% with 95% confidence. Secondary endpoints will include the toxicity of therapy, including surgical morbidity and mortality, the overall and disease-free survival, pattern of disease recurrence, and quality of life achieved during therapy, including relief of dysphagia.

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

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