Clinical trial NCT01853059: Functional Outcomes Following Anal Cancer Treatment
Official title: Observational Study of Functional Outcomes After Chemoradiotherapy for Squamous Cell Cancer of the Anus
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Anal Cancer
Keywords: Anal cancer
Squamous cell cancer
Radiotherapy
Chemoradiotherapy
Conformational radiotherapy
Intensity modulated radiation therapy
IMRT
Lead sponsor: Cambridge University Hospitals NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: The Christie NHS Foundation Trust
name: Bowel Disease Research Foundation
First posted: 2013-05-14
Enrollment: 176
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients under the care of the anal cancer multidisciplinary team in Addenbrookes, Cambridge and Christie Hospital, Manchester

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.


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

Primary outcomes:
measure: Functional quality of life after chemoradiotherapy for anal cancer
timeFrame: 3 years
Secondary outcomes:
measure: Patient-reported treatment-related toxicity after chemoradiotherapy for anal cancer
timeFrame: 3 years
Other outcomes:
Locations:
city: Cambridge
country: United Kingdom
facility: Addenbrookes Hospital
city: Manchester
country: United Kingdom
facility: Christie Hospital
Study officials:
References:
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.
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. doi: 10.1038/sj.pcan.4500938. Epub 2006 Dec 26.
citation: 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.