Spots Global Cancer Trial Database for Modulation of Adjuvant 5-FU by Folinic Acid and Interferon-alpha in Colon Cancer

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Trial Identification

Brief Title: Modulation of Adjuvant 5-FU by Folinic Acid and Interferon-alpha in Colon Cancer

Official Title: Phase 3 Study of Adjuvant Chemoradiotherapy of Advanced Resectable Rectal Cancer Comparing Modulation of 5-FU With Folinic Acid or With Interferon-alpha

Study ID: NCT01060501

Conditions

Rectal Cancer

Interventions

Folinic Acid, interferon-alpha

Study Description

Brief Summary: The primary objective was to improve adjuvant 5-FU chemoradiotherapy in resectable rectal cancer. The investigators hypothesis was that modulation of 5-FU by addition of either FA or INF-alpha may increase overall survival.

Detailed Description: 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.