Phase 3 Study of Adjuvant Chemoradiotherapy of Advanced Resectable Rectal Cancer Comparing Modulation of 5-FU With Folinic Acid or With Interferon-alpha
Primary endpoint was overall survival (OS). For sample size estimation the following
assumptions were made: The 5-year OS rate of 5-FU was estimated to be 58%. Our intention was
to detect an increase in the 5-year OS rate by one of the additives of at least 10% with a
power of 80% and a level of significance of 5% in comparison to 5-FU (one-sided). Hypotheses
were analyzed as pair wise comparisons between the treatment options. This resulted in a
target sample size of 280 patients per group and a total of 840 patients.
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
overall survival
5-year
No
"Federal Institute for Drugs and Medicinal Devices":Germany
FOGT1
NCT01060501
July 1992
July 2009
Name | Location |
---|