臨床研究等提出・公開システム

A pragmatic, randomized phase III trial of bi-weekly versus conventional schedule of TAS-102 plus bevacizumab for metastatic colorectal cancer (PRABITAS)

PRABITAS study

Taniguchi Hiroya

Aichi Cancer Center Hospital

1-1,Kanokoden,Chikusa-ku,Nagoya,Aichi

hiroya.taniguchi@aichi-cc.jp

Taniguchi Hiroya

Aichi Cancer Center Hospital

1-1,Kanokoden,Chikusa-ku,Nagoya,Aichi

+81-52-762-6111

hiroya.taniguchi@aichi-cc.jp

Not Recruiting

Dec. 21, 2023

Interventional

randomized controlled trial

open(masking not used)

no treatment control/standard of care control

parallel assignment

treatment purpose

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.

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.

Both

colorectal cancer

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

Overall survival:OS

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

+81-52-762-6111

Nov. 30, 2023

No

none