PRABITAS study

Authors
Category Primary study
Registry of TrialsJapan Primary Registry Network
Year 2023
INTERVENTION: Group A: Conventional FTD/TPI+BEV 1 cycle of 28 days FTD/TPI: 35mg/m2/dose, administered orally BID, day 1‐5, 8‐12 (day 2‐6, 9‐13) BEV: 5mg/kg, administered IV on day 1 and 15. Group B: Bi‐weekly FTD/TPI+BEV FTD/TPI: 35mg/m2/dose, administered orally BID, day 1‐5 (day 2‐6) BEV: 5mg/kg, administered IV on day 1 CONDITION: colorectal cancer PRIMARY OUTCOME: Overall survival:OS SECONDARY OUTCOME: Progression free survival: PFS; Response rate: RR; Disease control rate: DCR; Time to treatment failure: TTF ; Safety 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.
Epistemonikos ID: 555ecebf6f3b5f6499e09600e555c56b3a465850
First added on: Aug 28, 2024