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

NCT ID: NCT01060501

Last Updated: 2010-02-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 796 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1992-07-31
• Study Completion Date: 2009-07-31

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.

Conditions

Rectal Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

5-FU

Standard arm Systemic drug administration of 5-FU (intravenous)

Group Type: ACTIVE_COMPARATOR

Folinic Acid, interferon-alpha

Intervention Type: DRUG

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)

5-FU + folinic acid

Experimental arm Systemic drug administration of 5-FU + folinic acid (intravenous)

Group Type: EXPERIMENTAL

Folinic Acid, interferon-alpha

Intervention Type: DRUG

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)

5-FU + Interferon-alpha

Experimental arm Systemic drug administration of 5-FU + interferon-alpha (intravenous)

Group Type: EXPERIMENTAL

Folinic Acid, interferon-alpha

Intervention Type: DRUG

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)

Interventions

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)

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medac GmbH (Hamburg, Germany)

UNKNOWN

Sponsor Role: collaborator

Roche (Grenzach-Wyhlen, Germany)

UNKNOWN

Sponsor Role: collaborator

University of Ulm

OTHER

Sponsor Role: lead

Responsible Party

Study Group Oncology of Gastrointestinal Tumors (FOGT)

Locations

Department of General, Visceral, and Transplantation Surgery, University of Ulm

Ulm, , Germany

Countries

Germany

Other Identifiers

FOGT1

Identifier Type: -

Identifier Source: org_study_id