Functional Outcomes Following Anal Cancer Treatment (FOFACT)

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified May 2013 by Cambridge University Hospitals NHS Foundation Trust
Sponsor:
Collaborators:
Christie Hospital NHS Foundation Trust
Bowel Disease Research Foundation
Information provided by (Responsible Party):
Adam Stearns, Cambridge University Hospitals NHS Foundation Trust
ClinicalTrials.gov Identifier:
NCT01853059
First received: May 10, 2013
Last updated: May 13, 2013
Last verified: May 2013
  Purpose

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.


Condition
Anal Cancer

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Observational Study of Functional Outcomes After Chemoradiotherapy for Squamous Cell Cancer of the Anus

Resource links provided by NLM:


Further study details as provided by Cambridge University Hospitals NHS Foundation Trust:

Primary Outcome Measures:
  • Functional quality of life after chemoradiotherapy for anal cancer [ Time Frame: 3 years ] [ Designated as safety issue: No ]

    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


Secondary Outcome Measures:
  • Patient-reported treatment-related toxicity after chemoradiotherapy for anal cancer [ Time Frame: 3 years ] [ Designated as safety issue: No ]

    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)



Estimated Enrollment: 176
Study Start Date: October 2013
Estimated Study Completion Date: October 2017
Estimated Primary Completion Date: October 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts
IMRT
Prospective longitudinal assessment of patients receiving intensity-modulated radiation therapy for anal cancer
Conventional
Cross-sectional analysis of patients receiving conventional radiotherapy

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01853059

Contacts
Contact: Adam Stearns, MA DPhil BMBCh MRCS 01603286286

Locations
United Kingdom
Addenbrookes Hospital Not yet recruiting
Cambridge, United Kingdom, CB2 0QQ
Sub-Investigator: Adam T Stearns         
Principal Investigator: Nicola Fearnhead         
Sub-Investigator: Charles Wilson         
Sub-Investigator: Catherine Jephcott         
Sub-Investigator: Justin Davies         
Christie Hospital Not yet recruiting
Manchester, United Kingdom, M20 4BX
Principal Investigator: Andrew Renehan         
Sub-Investigator: Susan Davidson         
Sub-Investigator: Mark Saunders         
Sponsors and Collaborators
Cambridge University Hospitals NHS Foundation Trust
Christie Hospital NHS Foundation Trust
Bowel Disease Research Foundation
  More Information

Additional Information:
Publications:
Responsible Party: Adam Stearns, Specialist Registrar in Surgery, Cambridge University Hospitals NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT01853059     History of Changes
Other Study ID Numbers: A092896
Study First Received: May 10, 2013
Last Updated: May 13, 2013
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by Cambridge University Hospitals NHS Foundation Trust:
Anal cancer
Squamous cell cancer
Radiotherapy
Chemoradiotherapy
Conformational radiotherapy
Intensity modulated radiation therapy
IMRT

Additional relevant MeSH terms:
Anus Diseases
Carcinoma, Squamous Cell
Anus Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases

ClinicalTrials.gov processed this record on September 30, 2014