NCT01853059|Unknown
Functional Outcomes Following Anal Cancer Treatment
FOFACT
Observational Study of Functional Outcomes After Chemoradiotherapy for Squamous Cell Cancer of the Anus
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FOFACT
Observational Study of Functional Outcomes After Chemoradiotherapy for Squamous Cell Cancer of the Anus
Sponsor study identifier
observational
176
1 country
2
Study Start
October 2013
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
October 2017
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
October 2017
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 2017
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 10, 2013
Actual (reported)May 14, 2013
Actual (reported)October 2013
Date type not reportedThis date has not been verified as actual or estimated.
October 2017
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
October 2017
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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
Patient-reported treatment-related toxicity after chemoradiotherapy for anal cancer
3 years
Prospective longitudinal assessment of patients receiving intensity-modulated radiation therapy for anal cancer
Cross-sectional analysis of patients receiving conventional radiotherapy
Patients under the care of the anal cancer multidisciplinary team in Addenbrookes, Cambridge and Christie Hospital, Manchester
Addenbrookes Hospital
Cambridge, CB2 0QQ, United Kingdom
Christie Hospital
Manchester, M20 4BX, United Kingdom
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.
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.
First Submitted
May 10, 2013
First Posted
May 14, 2013
Study Start
October 2013
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
October 2017
Radiation Therapy Plus Fluorouracil With or Without Additional Chemotherapy in Treating Patients With Primary Anal Cancer
Shared Decision Making With Anal Cancer Patients on Radiation Dose
Contact the study team to confirm eligibility.
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.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
October 2017
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
May 15, 2013
Record last verified: 2013-05
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