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
  Purpose

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.


Condition Intervention Phase
Rectal Cancer
Drug: Folinic Acid, interferon-alpha
Phase 3

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

Resource links provided by NLM:


Further study details as provided by University of Ulm:

Primary Outcome Measures:
  • overall survival [ Time Frame: 5-year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • recurrence-free survival [ Time Frame: 5-year ] [ Designated as safety issue: No ]
  • Toxicity (WHO) [ Time Frame: 5-year ] [ Designated as safety issue: Yes ]

Enrollment: 796
Study Start Date: July 1992
Study Completion Date: July 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 5-FU
Standard arm Systemic drug administration of 5-FU (intravenous)
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)
Experimental: 5-FU + folinic acid
Experimental arm Systemic drug administration of 5-FU + folinic acid (intravenous)
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)
Experimental: 5-FU + Interferon-alpha
Experimental arm Systemic drug administration of 5-FU + interferon-alpha (intravenous)
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)

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01060501

Locations
Germany
Department of General, Visceral, and Transplantation Surgery, University of Ulm
Ulm, Germany, 89075
Sponsors and Collaborators
University of Ulm
Medac GmbH (Hamburg, Germany)
Roche (Grenzach-Wyhlen, Germany)
  More Information

Additional Information:
No publications provided

Responsible Party: Prof. Dr. Marko Kornmann, Study Group Oncology of Gastrointestinal Tumors (FOGT)
ClinicalTrials.gov Identifier: NCT01060501     History of Changes
Other Study ID Numbers: FOGT1
Study First Received: February 1, 2010
Last Updated: February 1, 2010
Health Authority: "Federal Institute for Drugs and Medicinal Devices":Germany

Keywords provided by University of Ulm:
rectal cancer
adjuvant chemoradiotherapy
5-FU, interferon-alpha
Locally advanced resectable rectal cancer (UICC stage II and III)
Adjuvant chemoradiotherapy

Additional relevant MeSH terms:
Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases
Interferon-alpha
Interferons
Fluorouracil
Leucovorin
Folic Acid
Levoleucovorin
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antineoplastic Agents
Immunosuppressive Agents
Vitamin B Complex
Vitamins

ClinicalTrials.gov processed this record on September 11, 2014