Functional Outcomes Following Anal Cancer Treatment

Anal Cancer Clinical Trial

— FOFACT  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01853059
• Other study ID #: A092896
• Status: Not yet recruiting
• Phase: N/A
• First received: May 10, 2013
• Last updated: May 13, 2013
• Start date: October 2013
• Est. completion date: October 2017

Study information

• Verified date: May 2013
• Source: Cambridge University Hospitals NHS Foundation Trust
• Contact: Adam Stearns, MA DPhil BMBCh MRCS
• Phone: 01603286286
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 176
• Est. completion date: October 2017
• Est. primary completion date: October 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Anal Cancer
• Anus Neoplasms
• Carcinoma, Squamous Cell

Locations

Country	Name	City	State
United Kingdom	Addenbrookes Hospital	Cambridge
United Kingdom	Christie Hospital	Manchester

Sponsors (3)

Lead Sponsor	Collaborator
Cambridge University Hospitals NHS Foundation Trust	Bowel Disease Research Foundation, Christie Hospital NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

References & Publications (3)

Barraclough LH, Routledge JA, Farnell DJ, Burns MP, Swindell R, Livsey JE, Davidson SE. Prospective analysis of patient-reported late toxicity following pelvic radiotherapy for gynaecological cancer. Radiother Oncol. 2012 Jun;103(3):327-32. doi: 10.1016/j.radonc.2012.04.018. Epub 2012 May 23. — View Citation

Brown MW, Brooks JP, Albert PS, Poggi MM. An analysis of erectile function after intensity modulated radiation therapy for localized prostate carcinoma. Prostate Cancer Prostatic Dis. 2007;10(2):189-93. Epub 2006 Dec 26. — View Citation

Provencher S, Oehler C, Lavertu S, Jolicoeur M, Fortin B, Donath D. Quality of life and tumor control after short split-course chemoradiation for anal canal carcinoma. Radiat Oncol. 2010 May 23;5:41. doi: 10.1186/1748-717X-5-41. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Functional quality of life after chemoradiotherapy for anal cancer	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	No
Secondary	Patient-reported treatment-related toxicity after chemoradiotherapy for anal cancer	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	No

External Links

•   Bowel Disease Research Foundation