PRIME-RT
Research type
Research Study
Full title
Priming the Tumour MicroEnvironment for Effective Treatment with Immunotherapy in Locally Advanced Rectal Cancer: A Phase II trial of Durvulamab in Combination with Extended Neoadjuvant Regimens in Rectal Cancer
IRAS ID
256921
Contact name
Campbell Roxburgh
Contact email
Sponsor organisation
NHS Greater Glasgow and Clyde
Eudract number
2019-001471-36
Duration of Study in the UK
5 years, 0 months, 1 days
Research summary
Title: PRIME-RT
A phase II trial of Durvalumab in combination with radiotherapy and chemotherapy for the neo-adjuvant treatment of locally advanced rectal cancer.Locally advanced rectal cancer is usually treated with radiotherapy and chemotherapy first followed by surgery. The treatment is important as it shrinks tumour making surgery more successful. In a small proportion of patients, there is the potential avoid surgery altogether if there is evidence of a complete response. This trial will recruit patients who require radiotherapy prior to surgery to cure their disease. We will investigate whether a combination of chemotherapy, radiotherapy in addition to immunotherapy can achieve higher rates of complete response allowing more patients to be managed with organ preservation avoiding radical surgery.
This trial will compare two different regimens of radiotherapy which are both used currently in standard practice. The radiotherapy treatment in both arms will be combined with an immunotherapy drug called Durvalumab and followed by a combination of Durvalumab and chemotherapy. The chemotherapy being used is currently used in the standard treatment of colorectal cancer. The immunotherapy has been used in trials of colorectal cancer previously but is not currently a standard treatment for localised rectal cancer prior to surgery.
The aim of this trial is to understand which combination of treatment results in the highest rates of complete response to allow us to consider avoiding surgery. In addition, by using biopsies of tumours from the patients on the trial before, during and after treatment we will learn about how the patient's own immune system is responding to the immunotherapy treatment. This information will then be used to do a bigger trial using the combination of chemotherapy, radiotherapy and immunotherapy treatments that have the highest rates of complete response with the least toxicity.
REC name
East of Scotland Research Ethics Service REC 2
REC reference
20/ES/0083
Date of REC Opinion
2 Oct 2020
REC opinion
Further Information Favourable Opinion