Randomized phase II study of oxaliplatin reintroduction and the biweekly XELOX in previously treated patients with metastatic colorectal cancer (ORION study)
- Conditions
- Colorectal Cancer
- Registration Number
- JPRN-UMIN000004122
- Lead Sponsor
- PO Epidemiological and Clinical Research Information Network (ECRIN)
- Brief Summary
RESULTS: A total of 46 patients were enrolled in the trial-22 patients were randomly assigned to the Q3W group and 23 to the Q2W group. The median TTF was 3.4 months in both groups (hazard ratio [HR] 1.053; p = 0.880). The median PFS and OS were 3.3 and 9.2 months in the Q2W group and 4.3 and 12.1 months in the Q3W group, respectively (HR 1.15; p = 0.153 and 0.672; p = 0.836). The most common grade 3-4 AEs in the Q3W and Q2W groups were fatigue (27.3 vs 21.7), neuropathy (9.1 vs 0 %) and diarrhea (9.1 vs 0 %), respectively.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 42
Not provided
1) blood transfusion or administration of blood products or hemopoietic factors (e.g. G-CSF) within 7 days before enrollment. 2) a history of serious drug hypersensitivity or serious drug allergy. 3) Grade 3 or 4 sensory neuropathy. 4) PD within the previous 2 months during prior oxaliplatin-based therapy. 5) less than 3 weeks after administration of folic acid preparation in prior chemotherapy 6) active double cancer within the past 5 years 7) uncontrolled pleural effusion or ascites 8) pericardial effusion 9) clinically important infection or suspected infection in febrile patients. 10) brain metastasis 11) significant electrocardiographic abnormality 12) clinically significant heart disease 13) severe pulmonary disease 14) fresh gastrointestinal bleeding 15) diarrhea(watery) or diarrhea that interferes with daily activities for patients with a stoma. 16) bleeding or intestinal obstruction 17) central nervous system disorders 18) senile dementia 19) patients who are judged to be unsuitable for this trial due to clinically significant mental / psychological disease etc 20) uncontrolled diabetes or diabetic neuropathy. 21) women who are pregnant, lactating, or wish to become pregnant. 22) patients who are judged to be ineligible by principal investigator for any other reason.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method time to treatment failure
- Secondary Outcome Measures
Name Time Method 1)evaluation of fatigue based on Cancer Fatigue Scale 2)relative dose intensity 3)response rate(Disease control rate) 4)progression free survival 5)adverse event 6)overall survival