Modulation of Adjuvant 5-FU by Folinic Acid and Interferon-alpha in Colon Cancer
FOGT1
Phase 3 Study of Adjuvant Chemoradiotherapy of Advanced Resectable Rectal Cancer Comparing Modulation of 5-FU With Folinic Acid or With Interferon-alpha
1 other identifier
interventional
796
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jul 1992
Longer than P75 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 1992
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2009
CompletedFirst Submitted
Initial submission to the registry
February 1, 2010
CompletedFirst Posted
Study publicly available on registry
February 2, 2010
CompletedFebruary 2, 2010
July 1, 1991
17 years
February 1, 2010
February 1, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
overall survival
5-year
Secondary Outcomes (2)
recurrence-free survival
5-year
Toxicity (WHO)
5-year
Study Arms (3)
5-FU
ACTIVE COMPARATORStandard arm Systemic drug administration of 5-FU (intravenous)
5-FU + folinic acid
EXPERIMENTALExperimental arm Systemic drug administration of 5-FU + folinic acid (intravenous)
5-FU + Interferon-alpha
EXPERIMENTALExperimental arm Systemic drug administration of 5-FU + interferon-alpha (intravenous)
Interventions
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)
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Ulmlead
- Medac GmbH (Hamburg, Germany)collaborator
- Roche (Grenzach-Wyhlen, Germany)collaborator
Study Sites (1)
Department of General, Visceral, and Transplantation Surgery, University of Ulm
Ulm, 89075, Germany
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
February 1, 2010
First Posted
February 2, 2010
Study Start
July 1, 1992
Primary Completion
July 1, 2009
Study Completion
July 1, 2009
Last Updated
February 2, 2010
Record last verified: 1991-07