Functional Outcomes Following Anal Cancer Treatment

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Brief Title

Functional Outcomes Following Anal Cancer Treatment

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.
    



Study Type

Observational


Primary Outcome

Functional quality of life after chemoradiotherapy for anal cancer

Secondary Outcome

 Patient-reported treatment-related toxicity after chemoradiotherapy for anal cancer

Condition

Anal Cancer


Study Arms / Comparison Groups

 IMRT
Description:  Prospective longitudinal assessment of patients receiving intensity-modulated radiation therapy for anal cancer

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information



Estimated Enrollment

176

Start Date

October 2013

Completion Date

October 2017

Primary Completion Date

October 2017

Eligibility Criteria

        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
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

, 01603286286, 

Location Countries

United Kingdom

Location Countries

United Kingdom

Administrative Informations


NCT ID

NCT01853059

Organization ID

A092896


Responsible Party

Principal Investigator

Study Sponsor

Cambridge University Hospitals NHS Foundation Trust

Collaborators

 The Christie NHS Foundation Trust

Study Sponsor

, , 


Verification Date

May 2013