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

UMIN ID: UMIN000001527

Registered date:01/01/2009

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Rectal cancer
• Date of first enrollment: 2009/01/01
• Target sample size: 540
• Countries of recruitment: Japan
• Study type: Interventional

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.

Outcome(s)

• Primary Outcome: Disease-free survival

Secondary Outcome

1) Overall survival
2) Relation between Clinical Parameters and prognosis

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 80years-old
• Gender: Male and Female

Include criteria

1)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 criteria

1)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

• Primary Sponsor: Japanese Foundation for Multidisciplinary Treatment of Cancer
• Source(s) of Monetary Support: Japanese Foundation for Multidisciplinary Treatment of Cancer