Investigating the Tumour Immune Response of Radiotherapy

Launched by UNIVERSITY OF MANCHESTER · Sep 30, 2021

Keywords

ClinConnect Summary

This clinical trial is looking at how radiotherapy, a common cancer treatment that uses high-energy rays to kill cancer cells, affects the immune system in patients with different types of cancer. Researchers will collect tissue and blood samples from participants before and after they receive radiotherapy to see how their immune response changes. The trial includes patients with various cancers, including cervical, rectal, head and neck cancers, as well as certain types of lymphomas and skin cancers.

To participate, candidates must be at least 18 years old and have been diagnosed with one of the mentioned cancers. They should be planning to receive radiotherapy and have a biopsy confirming their cancer type. Participants will be required to give their consent before joining the study, and they will undergo some tests to ensure they meet the study’s requirements. Overall, this trial aims to deepen our understanding of how radiotherapy interacts with the immune system, which may help improve treatment strategies in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Histologically confirmed cancer, Stage I-IV, in one of the following: Cervical, rectal, nodal Non-Hodgkin lymphoma, cutaneous lymphoma, Head \& neck cancer
• • Diagnostic/pre-treatment biopsy confirmed suitable for translational research \*
• • Performance status - ECOG 0-2 (Refer to appendix 1), ECOG 3 allowed for arm F (unrelated to underlying cancer) as this group of patients often have ECOG 3 due to age and comorbidities.
• • Age ≥ 18; no upper age limit.
• • Participant considered suitable for radiotherapy
• • Before participant registration, written informed consent must be given according to GCP and national regulations.
• \*Pre-treatment biopsy must be from the gross tumour volume within the planned radiation field and must also:
• • Have been formalin fixed for \>12h and \<72h
• • Have tumour tissue and morphology confirmed by H\&E staining
• • Contain sufficient tumour cells (approximately 100)
• Exclusion Criteria:
• • Participants deemed unsuitable for a biopsy (during or following radiotherapy) in the opinion of the treating oncologist.
• • Participants who have received chemotherapy within 28 days of starting radiotherapy.
• • Participants with intercurrent or past history of hepatitis B, C or human immunodeficiency virus infection if known. A negative test result for hepatitis B, C and HIV infection is required prior to inclusion in the study.