NCT05912075View on ClinicalTrials.gov

Preoperative Radiotherapy And ASTX660 in Rectum Cancer

PHASE1RecruitingINTERVENTIONAL
Enrollment

78

Participants

Timeline

Start Date

December 19, 2023

Primary Completion Date

January 1, 2028

Study Completion Date

January 31, 2029

Conditions
Locally-advanced Rectal Cancer
Interventions
DRUG

mFOLFIRINOX

prior to tolinapant (ASTX660) for 6 cycles over 12 weeks

RADIATION

Pelvic radiotherapy LCRT

50-Gy total dose in 25 daily fractions of 2 Gy (5 days per week from Monday to Friday) for 5 weeks

DRUG

Capecitabine

800 mg/m2 bid for 5 days per week (From Monday to Friday) for 25 days will be given concomitantly during the 5 weeks of radiotherapy

DRUG

TOLINAPANT (ASTX660)

starting from 14 days before the first dose of radiotherapy, for 10 weeks.

RADIATION

Pelvic radiotherapy SCRT

total dose of 25 Gy, in 5 daily fractions of 5 Gy for 1 week (5 days from Monday-Friday)

DRUG

FOLFOX4

given every 2 weeks for 9 cycles, starting 10 days after the last session of short course radiotherapy

DRUG

CAPOX

every 3 weeks for 6 cycles, starting 10 days after the last session of short course radiotherapy.

Trial Locations (2)

69373

NOT_YET_RECRUITING

Centre Léon Bérard, Lyon

94805

RECRUITING

Gustave Roussy, Villejuif

All Listed Sponsors
lead

Gustave Roussy, Cancer Campus, Grand Paris

OTHER