Modulation of Adjuvant 5-FU by Folinic Acid and Interferon-alpha in Colon Cancer (NCT01060501) | Clinical Trial Compass
CompletedPhase 3
Modulation of Adjuvant 5-FU by Folinic Acid and Interferon-alpha in Colon Cancer
Germany796 participantsStarted 1992-07
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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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.