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UMIN ID: UMIN000001527

Registered date:01/01/2009

Randomized Phase III Trial Comparing surgery-alone to UFT+PSK in Stage II Rectal Cancer

Basic Information

Recruitment status Complete: follow-up complete
Health condition(s) or Problem(s) studiedRectal cancer
Date of first enrollment2009/01/01
Target sample size540
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)Control group : surgery-alone UFT : Administered orally 400 mg/day thrice daily after meal for 5 days and followed by 2 days rest (one cycle) for one year after surgery. PSK:Administered orally 3 g/day thrice daily after meal for one year after surgery.


Primary OutcomeDisease-free survival
Secondary Outcome1) Overall survival 2) Relation between Clinical Parameters and prognosis

Key inclusion & exclusion criteria

Age minimum20years-old
Age maximum80years-old
GenderMale and Female
Include criteria1)Stage II,Histologically confirmed adenocarcinoma of the rectum. 2)Patients with resection of a rectal cancer with D2 or more lymph node dissection. 3)pN0 4)Performance status:0-2 5)Patients without receiving chemotherapy, radiation exposure, rectum resection (remove the local operation), and the excision of the pelvis lymph node ,including the treatment for the other carcinoma. 6)Patients who have satisfied the following the latest clinical test values in two weeks or after operation and within two weeks before the registration. 1.WBC:>= 3,000/mm3, <12,000/mm3 2.Neutrophile:>= 1,500/mm3 3.Hemoglobin:>= 9.0g/dL 4.Platelet:>= 100,000/mm3 5.Total bilirubin:< 1.5 mg/dL 6.AST,ALT:<100IU/L 7.Serum creatinine:<1.5mg/dL 7)Patient with starting the chemotherapy within 8 weeks after operation. 8)Patients who have given consent to participate in this clinical study by himself/herself.
Exclude criteria1)Ingestion impossibility or digestive organs stricture. 2)Serious coexisting illness. 3)Primary tumor in Proctos(P) or External skin (E). 4)Active synchronous or metachronous malignancy carcinoma in situ. 5)Pregnant or nursing. 6)Not suitable for participating in the study for any other reason.

Related Information


public contact
Name Japanese Foundation for Multidisciplinary Treatment of Cancer
Address TaniBuilding3F, 1-28-6, kameido, koutou-ku, Tokyo, 136-0071, Japan Japan
Telephone 03-5627-7594
Affiliation Japanese Foundation for Multidisciplinary Treatment of Cancer Office
scientific contact
Name Kiyotaka Okuno
Address 377-2 Ohno-higashi, Osaka-sayama 589-8511, Japan Japan
Affiliation Kinki University School of Medicine Department of Surgery