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Avelumab With Chemoradiation in Locally Advanced Rectal Cancer

NCT03299660 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 37

Last updated 2023-03-16

No results posted yet for this study

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.

Conditions

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

Sponsors & Collaborators

  • Peter MacCallum Cancer Centre, Australia

    lead OTHER

Principal Investigators

  • Michael Michael, A/Prof · Peter MacCallum Cancer Centre, Australia

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-04-30
Primary Completion
2023-02-28
Completion
2023-02-28

Countries

  • Australia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03299660 on ClinicalTrials.gov