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Clinical Trial Summary

The objective of this study is to assess the efficacy and toxicity of a 2 weekly regimen containing irinotecan combined with leucovorin-modified 5-fluorouracil in the setting of relapsed or refractory upper gastrointestinal tumours. Patients with locally advanced or metastatic adenocarcinoma originating from the oesophagogastric junction, stomach or pancreas who have previously received chemotherapy and have either failed to respond or who have relapsed after an initial response will be eligible for treatment in this study.

The response rate, failure-free survival and overall survival of treated patients with the two different regimes will be evaluated. Toxicity and quality of life will also be monitored closely.


Clinical Trial Description

n/a


Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic


Related Conditions & MeSH terms


NCT number NCT00220064
Study type Interventional
Source Royal Marsden NHS Foundation Trust
Contact
Status Completed
Phase Phase 2
Start date July 2000
Completion date November 2005

See also
  Status Clinical Trial Phase
Completed NCT00220168 - Phase II Trial Evaluating Irinotecan and Capecitabine Relapsed/Refractory Upper GI Tumours Phase 4