HiSCO 03 study

Phase 2

Conditions: Colorectal cancer

Registration Number: JPRN-jRCTs061180087

Lead Sponsor: Ohdan Hideki

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 70

Inclusion Criteria

1. Colorectal cancer patients (Histologically confirmed)
2. Stage III colorectal cancer patients
3. Patients who underwent R0 resecrion
4. ECOG Performance Status : 0 to 2
5. 80 years or more
6. No previous history of chemotherapy or radiotherapy for colorectal cancer
7. Within 8 weeks after operation
8. Adequate organ funcion
White blood cell count : greater than or equal to 3,000/mm3 and less than 12,000/mm3
Neutrophil : greater than or equal to 1,500/mm3
Platelet : greater than or equal to 7.5 x 104/mm3
Hemogrobin : greater than or equal to 9.0g/dL
Total bilirubin : less than or equal to 1.5mg/dL
AST(GOT), ALT(GPT) : less than or equal to 100IU/L
Serum creatinine : less than or equal to 1.5mg/dL
9. Oral food intake possible
10. Written informed consent

Exclusion Criteria

1.History of serious drug hypersensivity
2.Watery diarrhea
3.Cases with severe postoperative complication
4.Sever comorbidity
5.Synchronous or meachronous multiple malignancy within tha last 5 years disease free interval
6.Patients who have cognitive impairment or psychiatric disorder
7.Taking oral administration of warfarin potassium

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Feasibility<br><br>An aborted case because of the reason of 1) or 2) is regarded as an event. An aborted case because of the reason of 3) to 5) is regarded as a censored case and calculated the cumulative completion rate by the Kaplan-Meier method or the like. For the calculation of the confidence interval of the cumulative completion rate at 25 weeks after UFT / LV administration, Greenwood's equation is used.<br>1) Canceling due to side effects.<br>2) Canceling due to patient refusal.<br>3) Canceling due to complications after curative treatment.<br>4) Canceling due to recurrence or death.<br>5) Canceling cases due to patient transfers.

Secondary Outcome Measures