PRABITAS study

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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCTs041230120

Enrollment

890

Registered

2023-12-21

Start date

2023-12-26

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

colorectal cancer

Interventions

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/

Eligibility

Sex/Gender

All

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
Overall survival:OS	—

Secondary

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

Contacts

Public ContactHiroya Taniguchi

Aichi Cancer Center Hospital

hiroya.taniguchi@aichi-cc.jp+81-52-762-6111

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026