Phase II study of oxaliplatin based regimen in relapsed colon cancer patients treated with oxaliplatin based adjuvant

Phase 2

• Conditions: Colorectal cancer

• Registration Number: JPRN-UMIN000011348
• Lead Sponsor: Epidemiological and Clinical research Information Network (ECRIN)

Brief Summary

The median PFS was 11.5 months 95% confidence interval CI 8.3 16.0, the median OS was 45.4 months 95% CI 37.4 NA, and the RR was 56.0% 95% CI 42.3 68.8. Adverse events of grade 3 that occurred in 5% of cases were neutropenia in 6 patients 12%, peripheral sensory neuropathy in 5 patients 10%, diarrhea in 4 patients 8%, hypertension in 4 patients 8%, anorexia in 3 patients 6% and allergic reactions in 3 patients 6%.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-08-01
• Study Completion: 2022-03-31
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Not provided

Exclusion Criteria

1) Serious drug allergy. 2) Serious sensory abnormality or dysfunction 3) Presence of other active malignancies or a history of malignancies within the past 5 years 4) blood transfusion or hemopoietic factors (e.g. G-CSF) within 7 days . 5) Uncontrolled pleural effusion, ascites, or pericardial effusion. 6) Clinically significant infection. 7) brain metastasis 8) Clinically significant heart disease (myocardial infarction within 12 months, etc.). 9) Serious complication(intestinal obstruction, interstitial pneumonia, uncontrolled diabetes, peptic ulcer hypertension, renal failure, hepatic failure ) 10) fresh GI bleeding 11) Watery diarrhea 12) Central nervous system disorders 13) Dementia or clinically significant mental/neurological disorders. 14)Women who are pregnant, lactating, or wish to become pregnant. 15) Investigator's judgement.

Study & Design

• Study Type: Interventional
• Study Design: Not specified