PRABITAS study
Phase 3
Recruiting
- Conditions
- colorectal cancer
- Registration Number
- JPRN-jRCTs041230120
- Lead Sponsor
- Taniguchi Hiroya
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 890
Inclusion Criteria
1) Histopathologically diagnosed as adenocarcinoma of the colon.
2) Diagnosed as metastatic colorectal cancer.
3) Age 18 years or older on the date of consent.
4) ECOG PS of 0-2.
5) Confirmed RAS gene status by tumor tissue.
6) Received all fluoropyrimidines, oxaliplatin, irinotecan and molecular targeted agents.
7) No previous administration of FTD/TPI.
8) Ability to safely receive the protocol treatment.
9) Written informed consent obtained from the patient.
Exclusion Criteria
1) History of severe hypersensitivity reactions to components of FTD/TPI or BEV.
2) Pregnant or potentially pregnant women.
3) History of hemoptysis (more than 2.5 ml of fresh blood)
4)Judged ineligible for trial participation by the investigator.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Overall survival:OS
- Secondary Outcome Measures
Name Time Method Progression free survival: PFS<br>Response rate: RR<br>Disease control rate: DCR<br>Time to treatment failure: TTF <br>Safety