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

Rectal Cancer Clinical Trial

— FOGT1  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01060501
• Other study ID #: FOGT1
• Status: Completed
• Phase: Phase 3
• First received: February 1, 2010
• Last updated: February 1, 2010
• Start date: July 1992
• Est. completion date: July 2009

Study information

• Verified date: July 1991
• Source: University of Ulm
• Contact: n/a
• Is FDA regulated: No
• Health authority: "Federal Institute for Drugs and Medicinal Devices":Germany
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 796
• Est. completion date: July 2009
• Est. primary completion date: July 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Rectal Cancer

Intervention

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)

Locations

Country	Name	City	State
Germany	Department of General, Visceral, and Transplantation Surgery, University of Ulm	Ulm

Sponsors (3)

Lead Sponsor	Collaborator
University of Ulm	Medac GmbH (Hamburg, Germany), Roche (Grenzach-Wyhlen, Germany)

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	overall survival		5-year	No
Secondary	recurrence-free survival		5-year	No
Secondary	Toxicity (WHO)		5-year	Yes

External Links

•   homepage of institution