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

Overview

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.

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: July 2009

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.

Interventions

  • Drug: Folinic Acid, interferon-alpha
    • 5-FU, 450 mg/m² i.v. for 60 min, weekly for 52 weeks postoperatively Folinic acid, 200 mg/m² i.v. 10 min, weekly for 52 weeks postoperatively 6×10 (high6) I.U. as subcutaneous self injection 3x weekly. Training of self injection was initiated on day 28 (duration until week 52)

Arms, Groups and Cohorts

  • Active Comparator: 5-FU
    • Standard arm Systemic drug administration of 5-FU (intravenous)
  • Experimental: 5-FU + folinic acid
    • Experimental arm Systemic drug administration of 5-FU + folinic acid (intravenous)
  • Experimental: 5-FU + Interferon-alpha
    • Experimental arm Systemic drug administration of 5-FU + interferon-alpha (intravenous)

Clinical Trial Outcome Measures

Primary Measures

  • overall survival
    • Time Frame: 5-year

Secondary Measures

  • recurrence-free survival
    • Time Frame: 5-year
  • Toxicity (WHO)
    • Time Frame: 5-year

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Ulm
  • Collaborator
    • Medac GmbH (Hamburg, Germany)
  • Provider of Information About this Clinical Study
    • Prof. Dr. Marko Kornmann, Study Group Oncology of Gastrointestinal Tumors (FOGT)

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