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A randomized pilot study to search the predictive parameters of PSK responder in patients with colorectal cancer

A randomized pilot study to search the predictive parameters of PSK responder in patients with colorectal cancer - A randomized pilot study to search the predictive parameters of PSK responder in patients with colorectal cancer

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000010046
Enrollment
210
Registered
2013-02-14
Start date
2010-05-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

colorectal cancer

Interventions

1)Curative resection 2)UFT (Stage II) or UFT/LV (Stage III) for 1 year 1)Curative resection 2)UFT (Stage II) or UFT/LV (Stage III) combined with PSK for 1 year

Sponsors

Department of Digestive Surgery and Surgical Oncology, Yamaguchi University Graduate School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1)Histologically proven adenocarcinoma of colon cancer. 2)Patients with Stage II, III and recieved curative resection. 3)No prior radiotherapy, chemotherapy. 4)Age of 20 years or older, 79 years or younger. 5)ECOG Performance status:0-2. 6)Adequate organ functions: without watery diarrhea WBC >=3000/mm3, platelets >=100,000/mm3, AST(GOT)/ALT(GPT) <=100IU/L, total bilirubin <=2.0mg/dL, creatinine <=UNL. 7)Written informed consent.

Exclusion criteria

Exclusion criteria: 1)Patients with non-curative resection. 2)Patients with anal canal cancer. 3)Patients with GI stricture. 4)A large amount of pleural effusion or peritoneal fluid. 5)Infection 6)Active synchronous malignancy. 7)Pregnant females, possibly pregnant females, females wishing to become pregnant and nursing mothers. 8)Severe complications, such as uncontrolled diabetes mellitus. 9)Severe complications, such as heart failure. 10)Severe mental disorders. 11)Patients under treatment with steroid. 12)Other patients who are unfit for the study as determined by the attending physician.

Design outcomes

Primary

MeasureTime frame
3 years disease free survival

Countries

Japan

Contacts

Public ContactShigefumi Yoshino

Yamaguchi University Graduate School of Medicine Department of Digestive Surgery and Surgical Oncology

sigefumi@yamaguchi-u.ac.jp0836-22-2264

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026