A Trial Comparing Adjuvant Oral UFT/LV to 5-FU/l-LV in Stage III Colorectal Cancer (JCOG-0205-MF)
Colorectal Neoplasms
About this trial
This is an interventional treatment trial for Colorectal Neoplasms focused on measuring adjuvant chemotherapy, Stage III colorectal cancer, 5-FU+l-LV, UFT+LV, randomized controlled trial
Eligibility Criteria
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.
Sites / Locations
- Aichi Cancer Center Hospital
- Fujita Health University
- Chiba Cancer Center Hospital
- National Cancer Center Hospital East
- Toho University Sakura Hospital
- Jyuntendo Urayasu Hospital
- National Hospital Organization Shikoku Cancer Center
- National Kyushu Cancer Center
- Kurume University School of Medicine
- Kurume University Medical Center
- Gunma Prefectural Cancer Center
- Hiroshima University, School of Medicine
- Hiroshima City Hospital
- Sapporo-Kosei General Hospital
- Kansai Rosai Hospital
- Ibaraki Kenritsu Chuo Hospital & Cancer Center
- Ishikawa Prefectual Central Hospital
- Teikyo University Hospital, Mizonokuchi
- Kitasato University East Hospital
- Kitasato University School of Medichine
- Yokohama City University Medical Center
- Kanagawa Cancer Center
- Showa University Northern Yokohama Hospital
- National Hospital Organization Kyoto Medical Center
- Miyagi Cancer Center
- Nagano Municipal Hospital
- Niigata Cancer Center Hospital
- Oita University Fuculty of Medicine
- Okayama Saiseikai General Hospital
- Minoh City Hospital
- Osaka National Hospital
- Osaka Medical Center for Cancer and Cardiovascular Diseases
- Osaka City General Hospital
- Sakai Municipal Hospital
- Osaka University Graduate School of Medicine
- Osaka Medical College
- Omiya Medical Center, Jichi Medical School
- National Defense Medical College
- Sizuoka Cancer Center
- Tochigi Cancer Center
- Tokyo Medical and Dental University Hospital
- National Cancer Center Hospital
- Toho University Ohashi Hospital
- Toranomon Hospital
- Kyorin University School of Medicine
- Tokyo Medical University
- Keio University Hospital
- Yamagata Prefectural Central Hospital
Arms of the Study
Arm 1
Arm 2
Active Comparator
Experimental
1
2
5-FU/l-LV
UFT/LV