A phase II study to confirm the effectiveness of a sequence therapy consisted induction therapy (Capecitabin or S-1 or sLV/5-FU plus Bevacizumab) and following therapy (induction therapy + oxaliplatin) for unresectable advanced/recurrent colo-rectal cancer (OGSG 1107)
- Conditions
- Colo-rectal cancer
- Registration Number
- JPRN-UMIN000007004
- Lead Sponsor
- Osaka Gastrointestinal cancer chemotherapy Study Group(OGSG)
- Brief Summary
The median 1st PFS and 2nd PFS were 12.8 months (95% confidence interval {CI] 10.4-26.7) and 19.1 months (95% CI 16.1-not reached [NR] months), respectively. The median 1st PFS C-group (Capecitabine + bevacizumab): 17.2 months (95% CI: 11.1 - NR) S-group (S-1 + bevacizumab): 10.8 months (95% CI: 10.4 - NR) F-group(LV/5-FU + bevacizumab): 11.2 months (95% CI: 7.8 - NR)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 19
Not provided
1)with symptoms due to brain metastasis 2)with uncontrollable diarrhea 3)with difficulty on oral intake due to intestinal paralysis or obstruction 4)with infectious disease or febrile condition 5)HBs Ag (+) 6)with severe pulmonary diseases (interstitial pneumonia, pulmonary fibrosis, pulmonary emphysema etc.) 7)with severe diseases (uncontrollable DM, heart failure severe than NYHA III, renal failure and/or hepatic failure) 8)pregnant and/or nursing women, or women who expect pregnancy 9)with metastatic meningitis, uncontrollable convulsion, and/or mental disorder 10)with a more than grade 1 neural disorder 11)with a condition intolerant to medicines in this regimen (5-FU, Xeloda, TS-1, Avastine or Erplat) 12)with a history of allergy against 5-Fu, Capecitabine or TS-1 13)with a history of some chemotherapy and/or therapy including a VEGF antagonist for unresectable advanced/recurrent colon cancer 14)with a history of embolism, brain infarction (except Lacuna infarction) or pulmonary infarction 15)under easy bleeding condition due to some diseases or medicines (except low dose aspirin) 16)with a history of thoracic surgery or abdominal surgery 28 days ago except reservoir surgery 17)with active wounds 18)with a history of bloody spit more than 2.5mL 19)any other patient whom the physician in charge of the study judges to be unsuitable
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Progression Free Survival between the start of treatment and Progression of second line treatment (1st +2nd PFS)
- Secondary Outcome Measures
Name Time Method Progression Free Survival of 1st line treatment Response Rate Disease Control Rate Overall Survival Adverse Events (Incidence and Grades) Medicines with good response during overall treatment by KRAS status