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

Tracking Information
First Received Date ^ICMJE	February 1, 2010
Last Updated Date	February 1, 2010
Start Date ^ICMJE	July 1992
Primary Completion Date	July 2009 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: February 1, 2010)	overall survival [ Time Frame: 5-year ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	No Changes Posted
Current Secondary Outcome Measures ^ICMJE (submitted: February 1, 2010)	recurrence-free survival [ Time Frame: 5-year ] [ Designated as safety issue: No ] Toxicity (WHO) [ Time Frame: 5-year ] [ Designated as safety issue: Yes ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Modulation of Adjuvant 5-FU by Folinic Acid and Interferon-alpha in Colon Cancer
Official Title ^ICMJE	Phase 3 Study of Adjuvant Chemoradiotherapy of Advanced Resectable Rectal Cancer Comparing Modulation of 5-FU With Folinic Acid or With Interferon-alpha
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 Type ^ICMJE	Interventional
Study Phase	Phase 3
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Rectal Cancer
Intervention ^ICMJE	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)
Study Arm (s)	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
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	796
Completion Date	July 2009
Primary Completion Date	July 2009 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Germany

Administrative Information
NCT Number ^ICMJE	NCT01060501
Other Study ID Numbers ^ICMJE	FOGT1
Has Data Monitoring Committee	Yes
Responsible Party	Prof. Dr. Marko Kornmann, Study Group Oncology of Gastrointestinal Tumors (FOGT)
Study Sponsor ^ICMJE	University of Ulm
Collaborators ^ICMJE	Medac GmbH (Hamburg, Germany) Roche (Grenzach-Wyhlen, Germany)
Investigators ^ICMJE	Not Provided
Information Provided By	University of Ulm
Verification Date	July 1991
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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