PRABITAS study

JRCT ID: jRCTs041230120

Registered date:21/12/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: colorectal cancer
• Date of first enrollment: 26/12/2023
• Target sample size: 890
• Study type: Interventional

Intervention(s)

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

Outcome(s)

• Primary Outcome: Overall survival:OS

Secondary Outcome

Progression free survival: PFS
Response rate: RR
Disease control rate: DCR
Time to treatment failure: TTF
Safety

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include 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.

Exclude 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.

Related Information

• Primary Sponsor: Taniguchi Hiroya