Capecitabine Plus Concomitant Radiation Therapy Followed by Durvalumab as Preoperative Treatment in Rectal Cancer

PHASE2UnknownINTERVENTIONAL
Enrollment

100

Participants

Timeline

Start Date

January 1, 2020

Primary Completion Date

November 30, 2022

Study Completion Date

August 31, 2025

Conditions
RECTAL CANCER
Interventions
DRUG

Capecitabine

chemoradiation therapy with 825 mg/m2 twice daily capecitabine every day for 5 weeks

DRUG

Radiotherapy

5040 cGy radiotherapy for 5 days per week for 5 weeks

DRUG

Durvalumab

One week after the end of CT/RT patients will be treated with 1500 mg IV Q4W durvalumab for 3 administrations

Trial Locations (1)

48018

RECRUITING

Ospedale Degli Infermi Uo Oncologia, Faenza

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

AstraZeneca

INDUSTRY

collaborator

Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS

OTHER

lead

AUSL Romagna Rimini

OTHER