Investigating the Tumour Immune Response of Radiotherapy

Overview

This study aims to investigate immune changes which occur before and following standard radiotherapy in a range of tumour types. We will collect tissue and blood samples before and after radiation treatment from participants across six cancer types: cervical, rectal, Head and Neck cancer, nodal non-Hodgkin lymphoma, cutaneous lymphoma and cutaneous squamous cell carcinoma/ basal cell carcinoma.

Detailed description

The purpose of this prospective, non-CTIMP, translational study is to assess the feasibility of achieving paired biopsies for immune analysis in patients across six different cancer types: cervical, rectal, Head and Neck cancer, nodal non-Hodgkin lymphoma, cutaneous lymphoma and cutaneous squamous cell carcinoma/ basal cell carcinoma.

All participants will have a minimum of 1 mandatory biopsy (during/post-radiotherapy \[irradiated site\]) and the potential to have a pre-treatment biopsy if the archival biopsy does not meet the suitability criteria.

Matched blood samples will be collected from participants at baseline, during/post-radiotherapy, and if radiotherapy continues after the on-treatment biopsy is taken, an additional end of treatment blood sample will be collected.

We aim to recruit 10-20 participants per study arm, with the option to increase numbers in study arms that are recruiting well - a maximum of 120 patients in total will be recruited to the study.

Interventions

• Procedure Biopsy and blood sample collection
  A pre-treatment diagnostic biopsy sample plus 1 mandatory biopsy (during/post-radiotherapy \[irradiated site\]) will be collected from each participant. Matched blood samples will be collected from participants at baseline, during/post-radiotherapy, and if radiotherapy continues after the on-treatment biopsy is taken, an additional end of treatment blood sample will be collected.

Primary outcome measures

• Feasibility of obtaining paired biopsy samples [Time frame: Within 6-7 weeks of starting radiotherapy]
• Collection of matched blood samples [Time frame: Within 6-7 weeks of starting radiotherapy]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Cohort

Study locations

United Kingdom · 1 center

• Christie NHS Foundation Trust — Manchester

Identifiers

NCT: NCT05076500 · NHS001688 · 21-XTEAM-13

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗