Functional Outcomes Following Anal Cancer Treatment

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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01853059

Acronym

FOFACT

Enrollment

176

Registered

2013-05-14

Start date

2013-10-31

Completion date

2017-10-31

Last updated

2013-05-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anal Cancer

Keywords

Anal cancer, Squamous cell cancer, Radiotherapy, Chemoradiotherapy, Conformational radiotherapy, Intensity modulated radiation therapy, IMRT

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
Functional quality of life after chemoradiotherapy for anal cancer	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

Secondary

Measure	Time frame	Description
Patient-reported treatment-related toxicity after chemoradiotherapy for anal cancer	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)

Countries

United Kingdom

Contacts

Primary ContactAdam Stearns, MA DPhil BMBCh MRCS

01603286286

Outcome results