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Brief Title: Avelumab With Chemoradiation in Locally Advanced Rectal Cancer
Official Title: Phase II Trial PD-L1/PD-1 Blockade Avelumab (MSB0010718C) With Chemoradiotherapy for Locally Advanced Resectable Rectal Cancer
Study ID: NCT03299660
Brief Summary: This trial is investigating the inclusion of avelumab post long-course chemo-radiotherapy in patients with resectable locally advanced rectal cancer. It is hypothesised that this may enhance the pathological and imaging response rates whilst potentially reducing the relapse rates. Participants will receive standard long course chemoradiotherapy (LCCRT) treatment with radiotherapy and 5-fluorouracil (5 FU)/Capecitabine for 6 weeks, this then followed by 4 cycles of Avelumab and then surgical resection. The trial will measure disease response just prior to surgery and participants will be followed up for a minimum of 18 months (from study entry) and up to 42 months.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Prince of Wales Hospital, Randwick, New South Wales, Australia
Royal North Shore, St Leonards, New South Wales, Australia
Box Hill Hospital, Box hill, Victoria, Australia
Cabrini Hospital, Malvern, Victoria, Australia
Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia
Monash Health, Melbourne, Victoria, Australia
Alfred Hospital, Prahran, Victoria, Australia
Name: Michael Michael, A/Prof
Affiliation: Peter MacCallum Cancer Centre, Australia
Role: PRINCIPAL_INVESTIGATOR