NCT00590031

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.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 61 (actual)
• Sponsor: Memorial Sloan Kettering Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Esophageal Carcinoma

Interventions

Type	Name	Description
DRUG	Cisplatin	pts will receive weekly cisplatin 30mg/m2 after hydration on weeks 8,9,11 and 12
DRUG	Irinotecan	Irinotecan will be given 65 mg/m2
RADIATION	External Beam Radiation Therapy	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.

Timeline

• Start date: 2002-11-01
• Primary completion: 2009-12-01
• Completion: 2009-12-01
• First posted: 2008-01-10
• Last updated: 2016-01-25
• Results posted: 2016-01-25

Locations

1 site across 1 country: United States