Randomized Phase III Trial of Adjuvant Chemotherapy With UFT vs. Observation in Curatively Resected Stage II Colon Cancer
Randomized Phase III Trial of Adjuvant Chemotherapy With UFT vs. Observation in Curatively Resected Stage II Colon Cancer
RATIONALE: Drugs used in chemotherapy, such as tegafur-uracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving chemotherapy after surgery may kill any tumor cells that remain after surgery. Sometimes, after surgery, the tumor may not need more treatment until it progresses. In this case, observation may be sufficient. It is not yet known whether chemotherapy is more effective than observation in treating colorectal cancer.
PURPOSE: This randomized phase III trial is studying tegafur and uracil to see how well they work compared to observation in treating patients with stage II colorectal cancer that has been completely removed by surgery.
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a randomized, controlled study. Patients are randomized to 1 of 2 treatment arms.
After completion of study treatment, patients are followed periodically for 5 years.
PROJECTED ACCRUAL: A total of 2,000 patients will be accrued for this study.
DISEASE CHARACTERISTICS:
Histologically confirmed adenocarcinoma of the colon or rectosigmoid
Has undergone curative (R0) resection within the past 8 weeks
No suspicion of hereditary colorectal cancer
No severe postoperative complications
PATIENT CHARACTERISTICS:
ECOG performance status 0-1
WBC 3,500-12,000/mm³
Absolute neutrophil count ≥ 1,500/mm³
Platelet count ≥ 100,000/mm³
Hemoglobin ≥ 9.0 g/dL
Bilirubin ≤ 2.0 mg/dL
AST and ALT ≤ 100 IU/L
Creatinine ≤ 1.5 mg/dL
Not pregnant or nursing
Able to take oral medications
Major organ functions are preserved
No other active malignancy
None of the following conditions:
No psychiatric disease or other condition that would preclude study participation
PRIOR CONCURRENT THERAPY:
Aichi-gun, Aichi-ken 480-1100, Japan
Asahi-machi, Chiba 289-2511, Japan
Urayasu-shi, Chiba 279-0021, Japan
Yoshida-gun, Fukui 910-1193, Japan
Kitakyushu-shi, Fukuoka 807-8555, Japan
Ogaki-shi, Gifu 503-8502, Japan
Otashi, Gunma 373-8550, Japan
Fukuyama, Hiroshima 721-8581, Japan
Otaru-shi, Hokkaido 047-0031, Japan
Akou, Hyōgo 678-0232, Japan
Takarazukai, Hyōgo 665-0873, Japan
Yamsakicho, Hyōgo, Japan
Ibaraki, Ibaraki 311-3193, Japan
Kahoku-gun, Ishikawa-ken 920-0265, Japan
Ashigarakami-gun, Kanagawa 258-0003, Japan
Fujisawa-shi, Kanagawa 251-8550, Japan
Kumamoto, Kumamoto 860-8556, Japan
Yashiro, Kumamoto 866-0826, Japan
Higashiyama-ku, Kyoto 605-0981, Japan
Kanigyou-ku, Kyoto 602-8026, Japan
Sakyo-ku, Kyoto 606-8507, Japan
Thu-shi, Mie-ken 514-8507, Japan
Magasaki-shi, Nagasaki 852-8501, Japan
Sasebo-shi, Nagasaki 857-8511, Japan
Yamatotakada, Nara 635-0022, Japan
Yufu-shi, Oita Prefecture 879-5593, Japan
Kurashiki-shi, Okayama-ken 701-0192, Japan
Mino, Osaka 562-0014, Japan
Sakai-shi, Osaka 591-8025, Japan
Suita-shi, Osaka 564-0082, Japan
Kawagoe-shi, Saitama 350-8550, Japan
Saitamaken, Saitama 330-8503, Japan
Tokorozawa, Saitama 359-1151, Japan
Izumo-shi, Shimane 693-0068, Japan
Sunto-gun, Shizuoka 411-8777, Japan
Ohtawawa, Tochigi 324-0, Japan
Shimotsuga-gun, Tochigi 321-0293, Japan
Shimotsuke-shi, Tochigi 329-0498, Japan
Bunkyo-ku, Tokyo 113-0033, Japan
Chuo-ku, Tokyo 104-8560, Japan
Meguro-ku, Tokyo 153-8515, Japan
Minato-ku, Tokyo 105-8470, Japan
Shinjuku-ku, Tokyo 169-0073, Japan
Shinjyuku-ku, Tokyo 162-8666, Japan
Takaoka-shi, Toyama 933-8555, Japan
Wakayama, Wakayama 640-8435, Japan
Chu-o-shi, Yamanashi 409-3898, Japan
Aki-Gun, 731-4311, Japan
Numazu, Shizuoka, 410-0302, Japan
Suginami-ku, 166-8588, Japan