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

Phase 3

Completed

• Conditions: Rectal Cancer
• Interventions: Drug: Folinic Acid, interferon-alpha

• Registration Number: NCT01060501
• Lead Sponsor: University of Ulm

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.

Study Timeline

• Status Verified: 1991-07
• Study Start: 1992-07
• Primary Completion: 2009-07
• Study Completion: 2009-07
• Study First Submitted: 2010-02-01
• Study First Submitted QC: 2010-02-01
• Last Update Submitted: 2010-02-01
• Study First Posted: 2010-02-02
• Last Update Posted: 2010-02-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 796

Inclusion Criteria

• Eligibility was defined as potentially curative en-bloc resection (R0) of an adenocarcinoma of the rectum with a lower tumor edge within 12 cm from the anal verge determined by rectoscopy, a pathologic UICC stage II (pT3/4pN0M0) or III (pT1-4pNposM0) with examination of at least 12 lymph nodes, a white blood count ≥ 3,500/µl, a platelet count ≥ 100,000/µl, a ECOG performance status of 0 or 1, and written informed consent.

Exclusion Criteria

• Ineligible were patients not fulfilling these criteria or having a history of cancer except for adequately treated superficial basal or squamous cell skin cancer or in situ carcinoma of the cervix, getting previous radio- or chemotherapy, pregnant or nursing women, other having severe concomitant diseases limiting life expectancy or not allowing chemotherapy, and with social conditions not allowing a 5-year follow-up.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
5-FU	Folinic Acid, interferon-alpha	Standard arm Systemic drug administration of 5-FU (intravenous)
5-FU + folinic acid	Folinic Acid, interferon-alpha	Experimental arm Systemic drug administration of 5-FU + folinic acid (intravenous)
5-FU + Interferon-alpha	Folinic Acid, interferon-alpha	Experimental arm Systemic drug administration of 5-FU + interferon-alpha (intravenous)

Primary Outcome Measures

Name	Time	Method
overall survival	5-year

Secondary Outcome Measures

Name	Time	Method
recurrence-free survival	5-year
Toxicity (WHO)	5-year

Trial Locations

Locations (1)

Department of General, Visceral, and Transplantation Surgery, University of Ulm; 🇩🇪 Ulm, Germany