Irinotecan and Taxotere With Radiotherapy as Preoperative Treatment in Resectable Esophageal Cancer
|ClinicalTrials.gov Identifier: NCT00318903|
Recruitment Status : Completed
First Posted : April 27, 2006
Last Update Posted : January 4, 2011
|Condition or disease||Intervention/treatment||Phase|
|Esophageal Cancer Cancer of the Esophagus Esophagus Cancer Esophageal Neoplasm Cancer of Esophagus||Drug: Irinotecan (drug) Drug: Taxotere (drug) Procedure: Radiotherapy (procedure) Procedure: Esophagectomy (procedure)||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||25 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of Irinotecan and Taxotere With Concurrent Radiotherapy as a Preoperative Treatment in Resectable Esophageal Cancer|
|Study Start Date :||January 2002|
|Actual Study Completion Date :||April 2006|
Taxotere and Irinotecan is given intravenously for 3 consecutive weeks with a one-week break before radiotherapy for 5-6 weeks. A combination of Taxotere and Irinotecan will then be administered simultaneously with the radiotherapy.
Drug: Irinotecan (drug)
50 mg/m2 of Irinotecan will be administered intravenously over 60-90 minutes following a Taxotere infusion each week for 3 weeks. After a break, Irinotecan will then be given for 3 consecutive weeks at 45 mg/m2 in conjunction with radiotherapy.
Other Name: CamptosarDrug: Taxotere (drug)
Taxotere at 35 mg/m2 is given intravenously over 1 hour each week for three consecutive weeks. After a one-week break, patients will receive Taxotere at a 25 mg/m2 dose for the first three weeks of a 5-6 week radiotherapy regimen.
Other Name: DocetaxelProcedure: Radiotherapy (procedure)
Radiotherapy will be given in 28 fractions over 5-6 weeks at 1.8 Gy per fraction for a total of 50.4 Gy. This will begin concurrently with chemotherapy on Day 29 of treatment.Procedure: Esophagectomy (procedure)
After approximately 14 weeks of treatment, the patient will be evaluated for surgery. Only those who have achieved a good response will be eligible.
- The determination of pathologic response in patients who undergo surgical resection. [ Time Frame: Approximately 14 weeks before eligible patients have surgery ]
- To assess the overall survival, time to treatment failure, and quality of life in patients who receive any therapy [ Time Frame: Approximately 4 months ]
- To assess the toxicities associated with this treatment and any impact on surgery. [ Time Frame: Approximately 4 months ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00318903
|United States, Alabama|
|University of Alabama at Birmingham|
|Birmingham, Alabama, United States, 35294|
|Principal Investigator:||James A. Posey, M.D.||University of Alabama at Birmingham|