A Trial Comparing Adjuvant Oral UFT/LV to 5-FU/l-LV in Stage III Colorectal Cancer (JCOG-0205-MF)

Study Overview
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Brief Summary
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To evaluate the clinical effectiveness of oral UFT/LV comparing 5-FU/l-LV as adjuvant therapy for stage III colorectal cancer.

Detailed Description
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Oral fluoropyrimidines are widely used in practice for postoperative adjuvant chemotherapy for curatively resected colorectal cancer in Japan. In order to evaluate a clinical benefit of oral anticancer drugs in adjuvant chemotherapy, we conducted randomized controlled trial comparing the oral combination chemotherapy, UFT+LV, to the standard intravenous combination chemotherapy, 5-FU+l-LV, in stage III colorectal cancer. UFT+LV: UFT 300mg/m2/day and LV 75mg/day, orally for 28days with 7days rest, repeated five times every 5 weeks. 5-FU+l-LV: 5-FU 500mg/m2, l-LV 250mg/m2, weekly administration for 6 times, repeated three times every 8 weeks. Primary endpoints are disease-free survival and secondary endpoints are overall survival and adverse event rate.

Official Title
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Randomized Phase III Trial Comparing Adjuvant Oral UFT/LV to 5-FU/l-LV in Stage III Colorectal Cancer (JCOG-0205-MF)

Conditions
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Colorectal Neoplasms

Intervention / Treatment
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* Drug: 5FU+l-leucovorin
* Drug: UFT+Leucovorin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pathologically proved colorectal cancer (either adenocarcinoma, mucinous carcinoma, or signet-ring cell carcinoma). Tumor is mainly located in between cecum and upper rectum, excluding that invades to lower rectum. Stage III cancer by General Rules for Clinical and Pathological Studies on Cancer of the Colon, Rectum and Anus (6th ed.), excluding si(ai), n(-), M(-). No synchronous colorectal cancer which invade muscularis propria or deeper. Tumor resection with D2 or D3 lymph node dissection was performed. Pathological determination of curability of tumor resection is cur A. Age at registration is above 20 and below 75 years old. ECOG Performance status is 0 or 1. No prior chemotherapy or radiation therapy. Intake of normal diet and oral drugs is possible. Major organ function is preserved. WBC>=3,000/mcl, PLT>=100,000/mcl, GOT<=100 IU/L, GPT<=100 IU/L, T.Bil <=2.0 mg/dl, Cr<=1.5 mg/dl Adjuvant chemotherapy can be started within 9 weeks after surgery. Written informed consent is taken. Exclusion Criteria: Active co-existing malignancy （synchronous or metachronous malignancy whose disease free period is within 5 years). Carcinoma in situ is eligible. Severe postoperative complications which do not resolve until registration. There is following complication. insulin-controlling or uncontrollable diabetes mellitus, uncontrollable hypertension, myocardial infarction within six month or unstable angina pectoris, liver cirrhosis, interstitial pneumonia, pulmonary fibrosis, severe emphysema Pregnant or breast-feeding woman. Difficult to participate with the trial, having mental disorder or psychiatric symptoms. Judged to be inappropriate to register.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>5-FU/l-LV | Drug: 5FU+l-leucovorin<br>* 5FU+l-leucovorin<br>|
| Experimental: 2<br>UFT/LV | Drug: UFT+Leucovorin<br>* UFT+Leucovorin<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease-free survival |  | during the study conduct | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival |  | during the study conduct | 
| Rate of adverse event |  | during the study conduct | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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adjuvant chemotherapy, Stage III colorectal cancer, 5-FU+l-LV, UFT+LV, randomized controlled trial