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

Phase 3

• Conditions: Rectal cancer

• Registration Number: JPRN-UMIN000001527
• Lead Sponsor: Japanese Foundation for Multidisciplinary Treatment of Cancer

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-01-01
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 540

Inclusion 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.

Exclusion 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Disease-free survival

Secondary Outcome Measures

Name	Time	Method
1) Overall survival<br>2) Relation between Clinical Parameters and prognosis