Phase II study of oxaliplatin reintroduction treated with biweekly S-1 plus oxaliplatin (SOX) in patients with metastatic colorectal cancer.(ORION2)

Phase 2

• Conditions: Colorectal cancer

• Registration Number: JPRN-UMIN000013277
• Lead Sponsor: Epidemiological and Clinical research Information Network (ECRIN)

Brief Summary

Biweekly S-1 plus oxaliplatin (SOX) reintroduction in previously treated metastatic colorectal cancer patients (ORION 2 study): a phase II study to evaluate the efficacy and safety. Hiroaki Tanioka. et al; Int J Clin Oncol. 2019 Feb 18. [Epub ahead of print] RESULTS: A total of 41 patients from 12 institutes were enrolled. The median PFS and OS survival were 3.3 months (95% confidence interval [CI] 2.7-4.2) and 10.1 months (8.3-14.6), and response rate and disease control rate were 10.0% and 65.0%, respectively. Grade 3 AEs included thrombocytopenia (5.0%), anorexia (5.0%), pneumonia (5.0%) and fatigue (5.0%). There were no cases of grade 4 AEs or treatment-related death.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-03-01
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Not provided

Exclusion Criteria

1) Serious sensory abnormality or dysfunction 2) PD within 2 months during previous oxaliplatin-based therapy 3) Serious drug allergy 4) Presence of other active malignancies or a history of malignancies within the past 5 years 5) Blood transfusion or hemopoietic factors (G-CSF) within 7 days 6) Uncontrolled pleural effusion, ascites, or pericardial effusion 7) Clinically significant infection 8) Brain metastasis 9) Clinically significant heart disease (myocardial infarction within 12 months, etc) 10) Serious complication(intestinal obstruction, interstitial pneumonia, uncontrolled diabetes, peptic ulcer hypertension, renal failure, hepatic failure) 11) Fresh GI bleeding 12) Watery diarrhea 13) Central nervous system disorders 14) Dementia or clinically significant mental/neurological disorders 15) Patients who need flucytosine, phenytoin or warfarin potassium 16) Women who are pregnant, lactating, or wish to become pregnant 17) Investigator's judgement

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Progression free survival

Secondary Outcome Measures

Name	Time	Method
Overall survival Time to treatment failure Response rate Dose intensity Relative dose intensity Adverse event