Metastatic or locoregional recurrent anal cancer

Gender Neutral
Type Module
Testing Phase I / II - in development
Principal investigator(s)
Vassilios Vassiliou
Principal investigator
Bank of Cyprus Oncology Centre
Limassol, Cyprus
, Samantha Sodergren
Principal investigator
University of Southampton
Southampton, United Kingdom
Study coordinator(s)
Dan Aze
Principal investigator
University of Southampton
Southampton, United Kingdom

Project summary

The QLQ-ANL27 is a HRQoL instrument for assessing the acute and long-term sequelae of anal cancer treated with chemotherapy and radiotherapy (CRT). The QLQ-ANL27 is usable, reliable, valid and acceptable across different geographical regions and has been translated into 16 languages.

We have now started work involving patients with metastatic or recurrent/persistent anal cancer with the following objectives:

1. Identify the HRQoL issues of importance and relevance to patients with metastatic anal cancer or those with extensive local or locoregional recurrence treated with systemic therapies.
2. Investigate whether the existing EORTC QLQ-ANL27 is suitable for use in the context of metastatic or locoregional recurrent anal cancer or whether this measure needs to be supplemented with additional items.

Achievements

The study is currently in Phase 1a: Generation of quality of life issues of importance and relevance to people with metastatic or recurrent/ persistent anal cancer.

  • Approvals from the Sponsor (University of Southampton) and the research ethics committee of the lead country (UK) have been awarded.
  • A systematic review of the literature on the quality of life of patients with metastatic or recurrent / persistent anal cancer has been conducted and a publication drafted.
  • Patient and health care professional interviews on the issues which impact quality of life in the group of people have started.
  • Several recruiting centres are in set-up.

Future plans

We hope to complete Phase 1a by the end of January 2025 and move onto Phase 1b: Issue review, in March 2025. The current end date for all study activities is 31 March 2026.

NOTE:

If you are interested in collaborating with us or would like more information about our work, please get in touch with the study coordinator Samantha Sodergren (S.C.Sodergren@soton.ac.uk).

 

For patients

Anal cancer is rare and for most people with this cancer, treatment with chemotherapy and radiotherapy (CRT) in combination is successful. Patients often experience short-term and long-lasting problems affecting their quality of life. For a small percentage of these patients (around 15%), the cancer spreads or comes back again. This project is interested in the quality of life of these patients.

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