Functional Outcomes Following Anal Cancer Treatment

Study Overview
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Brief Summary
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Anal cancer is treated with chemoradiotherapy- combined chemotherapy and radiotherapy. This is very successful (75% long term survival). During the course of the radiotherapy, other organs in the pelvis may be damaged. This can lead to long-term problems with possible changes to the skin, bowels with diarrhoea and incontinence problems, bladder shrinkage and incontinence of urine, sexual problems including impotence and ejaculatory problems, or pain during sexual intercourse with vaginal dryness and shrinkage. Patients should be offered help with these side effects. At present, there is very little information on the effect treatment has on a patient's quality of life, making it difficult to judge if new treatment methods are better. This project will measure quality of life from the patient's perspective after treatment for anal cancer. It will also gather preliminary data on quality of life after the introduction of a new technique for more precise 3D-targeting of radiotherapy beams at the cancer, called IMRT.

Official Title
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Observational Study of Functional Outcomes After Chemoradiotherapy for Squamous Cell Cancer of the Anus

Conditions
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Anal Cancer

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participant is willing and able to give informed consent for participation in the study. Male or Female, aged 18 years or above. Squamous cell or basaloid carcinoma of the anal canal Exclusion Criteria: adenocarcinoma, melanoma, lymphoma, sarcoma or other malignancy of anal canal Any synchronous or metanchronous pelvic malignancy of non-anal origin (eg. prostatic, genital tract) unable to complete questionnaire

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| IMRT<br>Prospective longitudinal assessment of patients receiving intensity-modulated radiation therapy for anal cancer | |
| Conventional<br>Cross-sectional analysis of patients receiving conventional radiotherapy | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional quality of life after chemoradiotherapy for anal cancer | Quality of life measured using: General EORTC (European Organisation for Research and Treatment of Cancer) QLQ-C30 Disease specific EORTC QLQ-CR29 Vaizey incontinence score MOS (Medical Outcomes Survey) sexual questionnaire | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient-reported treatment-related toxicity after chemoradiotherapy for anal cancer | Patient-reported treatment related toxicity measured with: Common Terminology Criteria for Adverse Events (CTCAE version 3) Pelvis questionnaire male & female (LENT/SOMA) (LENT/SOMA: see Barraclough LH et al. Radiother Oncol; 103:327-32) | 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Anal cancer, Squamous cell cancer, Radiotherapy, Chemoradiotherapy, Conformational radiotherapy, Intensity modulated radiation therapy, IMRT