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

Primary Purpose

Rectal Cancer

Status
Completed
Phase
Phase 3
Locations
Germany
Study Type
Interventional
Intervention
Folinic Acid, interferon-alpha
Sponsored by
University of Ulm
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rectal Cancer focused on measuring rectal cancer, adjuvant chemoradiotherapy, 5-FU, interferon-alpha, Locally advanced resectable rectal cancer (UICC stage II and III)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

5-FU

5-FU + folinic acid

5-FU + Interferon-alpha

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

overall survival

Secondary Outcome Measures

recurrence-free survival
Toxicity (WHO)

Full Information

First Posted
February 1, 2010
Last Updated
February 1, 2010
Sponsor
University of Ulm
Collaborators
Medac GmbH (Hamburg, Germany), Roche (Grenzach-Wyhlen, Germany)
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1. Study Identification

Unique Protocol Identification Number
NCT01060501
Brief Title
Modulation of Adjuvant 5-FU by Folinic Acid and Interferon-alpha in Colon Cancer
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 1991
Overall Recruitment Status
Completed
Study Start Date
July 1992 (undefined)
Primary Completion Date
July 2009 (Actual)
Study Completion Date
July 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of Ulm
Collaborators
Medac GmbH (Hamburg, Germany), Roche (Grenzach-Wyhlen, Germany)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rectal Cancer
Keywords
rectal cancer, adjuvant chemoradiotherapy, 5-FU, interferon-alpha, Locally advanced resectable rectal cancer (UICC stage II and III)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
796 (Actual)

8. Arms, Groups, and Interventions

Arm Title
5-FU
Arm Type
Active Comparator
Arm Description
Standard arm Systemic drug administration of 5-FU (intravenous)
Arm Title
5-FU + folinic acid
Arm Type
Experimental
Arm Description
Experimental arm Systemic drug administration of 5-FU + folinic acid (intravenous)
Arm Title
5-FU + Interferon-alpha
Arm Type
Experimental
Arm Description
Experimental arm Systemic drug administration of 5-FU + interferon-alpha (intravenous)
Intervention Type
Drug
Intervention Name(s)
Folinic Acid, interferon-alpha
Intervention Description
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)
Primary Outcome Measure Information:
Title
overall survival
Time Frame
5-year
Secondary Outcome Measure Information:
Title
recurrence-free survival
Time Frame
5-year
Title
Toxicity (WHO)
Time Frame
5-year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Department of General, Visceral, and Transplantation Surgery, University of Ulm
City
Ulm
ZIP/Postal Code
89075
Country
Germany

12. IPD Sharing Statement

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

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