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Functional Outcomes Following Anal Cancer Treatment (FOFACT)

NHS Foundation Trust logo

NHS Foundation Trust

Status

Unknown

Conditions

Anal Cancer

Study type

Observational

Funder types

Other

Identifiers

NCT01853059
A092896

Details and patient eligibility

About

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.

Enrollment

176 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

176 participants in 2 patient groups

IMRT
Description:
Prospective longitudinal assessment of patients receiving intensity-modulated radiation therapy for anal cancer
Conventional
Description:
Cross-sectional analysis of patients receiving conventional radiotherapy

Trial contacts and locations

2

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Central trial contact

Adam Stearns, MA DPhil BMBCh MRCS

Data sourced from clinicaltrials.gov

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