A tolerability study in Japan of Oxaliplatin, fluorouracil, and l-leucovorin for patients with stage II/III colon cancer

Phase 4

• Conditions: StageII/III colon cancer

• Registration Number: JPRN-UMIN000004443
• Lead Sponsor: Japanese Foundation for Multidisciplinary Treatment of Cancer

Brief Summary

The PSN for >=8 days and the incidence of Gr.>=3 AR were 3.3% and 1.7%, respectively. At the onset of PSN, the median total dose of L-OHP and the median number of courses were 672.5mg/m2 and 9, respectively, while the corresponding values were 565.1mg/m2 and 7.5 at the onset of Gr.>=3 AR. Gr.3PSN appeared to gradually recover from 5.8% to 1.1%, 0.5%, and 0.2% at 12mths, 24mths and 36mths after enrollment, respectively. However, Gr.1 or Gr.2 PSNs after 3yrs follow-up were observed in 21.0% of patients.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-11-01
• Study Completion: 2015-03-01
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 882

Inclusion Criteria

Not provided

Exclusion Criteria

1) Women who are pregnant or breast-feeding. 2) Women who are planning to become pregnant. 3) Appendix cancer. 4) Patients with a history of malignancy. 5) Participating in another clinical trial within 30 days. 6) Peripheral sensory neuropathy >= Grade 1. 7) Insulin-treated diabetic patients. 8) Uncontrolled congestive heart failure, angina pectoris, hypertension, and arrhythmia. 9) Patients with a history of significant neurological or mental illness. 10) Active infectious disease. 11) Other patients who are unfit for the study as determined by the attending physician.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The frequency of allergies, anaphylaxis, and peripheral sensory neuropathy lasting for 8 days (Grade 3 or 4).

Secondary Outcome Measures

Name	Time	Method
(1) Disease-free survival. (2) Relapse-free survival. (3) Time to treatment failure. (4) Overall survival. (5) Adverse events. (6) Peripheral neuropathy. (7) Completion rate. (8) Relative dose intensity. (9) Relationship between lymph node metastasis and prognosis. (10) Exploration of predictors of the prognosis and adverse events (Additional study).