Clinical Trial: Functional Outcomes Following Anal Cancer Treatment

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Observational

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

Brief Summary:

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.


Detailed Summary:
Sponsor: Cambridge University Hospitals NHS Foundation Trust

Current Primary Outcome: Functional quality of life after chemoradiotherapy for anal cancer [ Time Frame: 3 years ]

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


Original Primary Outcome: Functional quality of life after chemoradiotherapy for anal cancer [ Time Frame: 3 years ]

Current Secondary Outcome: Patient-reported treatment-related toxicity after chemoradiotherapy for anal cancer [ Time Frame: 3 years ]

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)



Original Secondary Outcome: Patient-reported treatment-related toxicity after chemoradiotherapy for anal cancer [ Time Frame: 3 years ]

Information By: Cambridge University Hospitals NHS Foundation Trust

Dates:
Date Received: May 10, 2013
Date Started: October 2013
Date Completion: October 2017
Last Updated: May 13, 2013
Last Verified: May 2013