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Academic radiation oncology: outcome measures

The aim of the outcome measures group is to develop a robust clinical tool to record and score acute and late normal-tissue effects of cancer treatments, specifically radiotherapy. Currently there is a recognized need for an international scoring system both in clinical trials (to facilitate accurate assessment of new technologies) and in clinical practice.

Background

Major advances in cancer prevention, early detection and treatment are resulting in longer survival. Cancer survivors can face a number of problems, which include the long-term effects of treatment on normal tissues. The likelihood of surviving with treatment effects is increased with combined modality treatment.

Improved measurement and assessment of the long-term burden of illness has been highlighted as important for future prospective research. Although tumour outcome and acute toxicity reporting is fairly standardized, there is no consensus as to how best to quantify late normal-tissue effects. The recognition and grading of toxicity caused by cancer treatment is a critical endpoint in clinical trials.

In 1995 the EORTC and RTOG published the late effects in normal tissues subjective, objective, management and analytic scales (LENT SOMA) in an attempt to devise an international scoring system. These scales were not ready to be adopted for widespread clinical use. To address this, the OM group established validation studies, produced user-friendly questionnaires to obtain normal tissue outcome data. In 2003, the NCI published the Common Terminology Criteria for Adverse Events (CTCAE) which incorporated the LENT SOMA items with early and late effects contained in one system.

For further details, see: Common Terminology Criteria for Adverse Events (National Cancer Institute website)

Need for measurement and assessment of late effects

Measurement and assessment of late effects needs to be integrated into current patient management to:

• Provide adequate information to the patient regarding complications associated with their treatment
• Facilitate appropriate management for these complications
• Improve multidisciplinary support for patients suffering from normal-tissue effects
• Permit modification of treatment regimes to account for and reduce normal-tissue effects
• Facilitate the development of predictive testing for normal-tissue effects

The work of the group is supported by a CRUK project grant entitled 'Survivorship Issues: Improving measurement of the long term effects of cancer treatment'.

Research plan

In outline, the research plan is:

1. The development of CTCAE questionnaires
2. Conduct a randomized cross-over study to compare electronic versus paper versions of the CTCAE with patient feedback
3. Translation of questionnaires and assessment in a multi-centre, multi-national prospective randomized trial. A Coordinated Research Project supported by the International Atomic Energy Agency in 6 countries has been established for the treatment of cervix cancer. In three of the participating centres CTCAE questionnaires will be used in follow-up to see if this improves treatment toxicity data capture
4. Prospective correlative DCE-MRI study to assess the value of this imaging technique in the measurement of radiotherapy effects on normal tissue within the pelvis

An application is being made to the Department of Health to fund a programme of work that would develop and introduce structured, systematic follow-up for radiotherapy patients delivered by appropriate healthcare professionals. The initial work is planned in patients with rectal, prostate and gynaecological cancers who have received pelvic radiotherapy. The programme will refine and rationalise the current mechanisms of pelvic cancer radiotherapy patient follow-up.

The research questions posed will be:

1. Does the implementation of a site-specific toxicity questionnaire to identify patients' symptoms and treatment effects improve the quality of clinical outcome data?
2. As a result of identifying symptomatic patients with the questionnaire, can a structured and systematic RT follow up pathway rationalise access to specialist care and improve outcome?
3. Who is the most appropriate healthcare professional to conduct cancer patient follow-up and where should this take place?
4. When and how often should radiotherapy (RT) follow-up be conducted?
5. Can we demonstrate benefit and cost-effectiveness in the delivery of structured follow-up to best meet the needs of patients and clinicians?
6. Does a more specific and informative measure need to be added to the quality-adjusted life year (QALY) for patients who have received RT?
7. Can we develop evidence based advice for commissioners?

Outcome measures group

• Dr Susan E Davidson
  Clinical Oncologist
• Jacki Routledge
  Research nurse (OMG)
• Dr Damian Farnell
  Statistician (OMG)

Collaborators

• Søren M Bentzen (PhD, DSc)
  Professor of Human Oncology, Professor of Medical Physics, Director of Research and Education of Human Oncology, University of Wisconsin School of Medicine and Public Health, Madison, WI 53792, USA
• Andy Trotti (MD)
  Professor of Radiation Oncology, H Lee Moffitt Cancer Center at USF, Tampa, Florida 33612, USA

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