Avelumab With Chemoradiation in Locally Advanced Rectal Cancer

PHASE2CompletedINTERVENTIONAL
Enrollment

37

Participants

Timeline

Start Date

April 30, 2018

Primary Completion Date

February 28, 2023

Study Completion Date

February 28, 2023

Conditions
Rectal Cancer
Interventions
DRUG

Avelumab

Avelumab 10 mg/Kg every 2 weeks for 4 cycles post LCCRT

DRUG

5 Fluorouracil

5FU continuous infusion 225mg/m2/day during radiotherapy

DRUG

Capecitabine Pill

Can be administered in place of 5FU infusion. Dose = 825 mg/m2 twice a day on each day of radiotherapy

RADIATION

Radiotherapy

50.4 Gy in 28 fractions delivered over 5.5 weeks as 5 fractions/week

PROCEDURE

Surgical Resection

Surgical resection of tumour mass post radiotherapy and chemotherapy

Trial Locations (7)

2031

Prince of Wales Hospital, Randwick

2065

Royal North Shore, St Leonards

3000

Alfred Hospital, Prahran

3002

Peter MacCallum Cancer Centre, Melbourne

3128

Box Hill Hospital, Box Hill

3144

Cabrini Hospital, Malvern

Unknown

Monash Health, Melbourne

All Listed Sponsors
lead

Peter MacCallum Cancer Centre, Australia

OTHER

NCT03299660 - Avelumab With Chemoradiation in Locally Advanced Rectal Cancer | Biotech Hunter | Biotech Hunter