Functional Outcomes Following Anal Cancer Treatment (FOFACT)

May 13, 2013 updated by: Adam Stearns, Cambridge University Hospitals NHS Foundation Trust

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

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 Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

176

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Adam Stearns, MA DPhil BMBCh MRCS
  • Phone Number: 01603286286

Study Locations

  • United Kingdom
      • Cambridge, United Kingdom, CB2 0QQ
        • Addenbrookes Hospital
        • Sub-Investigator:
          • Adam T Stearns
        • Principal Investigator:
          • Nicola Fearnhead
        • Sub-Investigator:
          • Charles Wilson
        • Sub-Investigator:
          • Catherine Jephcott
        • Sub-Investigator:
          • Justin Davies
      • Manchester, United Kingdom, M20 4BX
        • Christie Hospital
        • Principal Investigator:
          • Andrew Renehan
        • Sub-Investigator:
          • Susan Davidson
        • Sub-Investigator:
          • Mark Saunders

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients under the care of the anal cancer multidisciplinary team in Addenbrookes, Cambridge and Christie Hospital, Manchester

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cambridge University Hospitals NHS Foundation Trust

Collaborators

The Christie NHS Foundation Trust
Bowel Disease Research Foundation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2013

Primary Completion (ANTICIPATED)

October 1, 2017

Study Completion (ANTICIPATED)

October 1, 2017

Study Registration Dates

First Submitted

May 10, 2013

First Submitted That Met QC Criteria

May 10, 2013

First Posted (ESTIMATE)

May 14, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

May 15, 2013

Last Update Submitted That Met QC Criteria

May 13, 2013

Last Verified

May 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A092896

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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