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Modulation of Adjuvant 5-FU by Folinic Acid and Interferon-alpha in Colon Cancer (FOGT1)

This study has been completed.
Sponsor:
Collaborators:
Medac GmbH (Hamburg, Germany)
Roche (Grenzach-Wyhlen, Germany)
Information provided by:
University of Ulm
ClinicalTrials.gov Identifier:
NCT01060501
First received: February 1, 2010
Last updated: NA
Last verified: July 1991
History: No changes posted

February 1, 2010
February 1, 2010
July 1992
July 2009   (final data collection date for primary outcome measure)
overall survival [ Time Frame: 5-year ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
  • recurrence-free survival [ Time Frame: 5-year ] [ Designated as safety issue: No ]
  • Toxicity (WHO) [ Time Frame: 5-year ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Modulation of Adjuvant 5-FU by Folinic Acid and Interferon-alpha in Colon Cancer
Phase 3 Study of Adjuvant Chemoradiotherapy of Advanced Resectable Rectal Cancer Comparing Modulation of 5-FU With Folinic Acid or With Interferon-alpha

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.

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
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Rectal Cancer
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 6x10 (high6) I.U. as subcutaneous self injection 3x weekly. Training of self injection was initiated on day 28 (duration until week 52)
  • Active Comparator: 5-FU
    Standard arm Systemic drug administration of 5-FU (intravenous)
    Intervention: Drug: Folinic Acid, interferon-alpha
  • Experimental: 5-FU + folinic acid
    Experimental arm Systemic drug administration of 5-FU + folinic acid (intravenous)
    Intervention: Drug: Folinic Acid, interferon-alpha
  • Experimental: 5-FU + Interferon-alpha
    Experimental arm Systemic drug administration of 5-FU + interferon-alpha (intravenous)
    Intervention: Drug: Folinic Acid, interferon-alpha
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
796
July 2009
July 2009   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT01060501
FOGT1
Yes
Prof. Dr. Marko Kornmann, Study Group Oncology of Gastrointestinal Tumors (FOGT)
University of Ulm
  • Medac GmbH (Hamburg, Germany)
  • Roche (Grenzach-Wyhlen, Germany)
Not Provided
University of Ulm
July 1991

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP