Functional Outcomes Following Anal Cancer Treatment

Overview

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.

Full Title of Study: “Observational Study of Functional Outcomes After Chemoradiotherapy for Squamous Cell Cancer of the Anus”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: October 2017

Arms, Groups and Cohorts

  • IMRT
    • Prospective longitudinal assessment of patients receiving intensity-modulated radiation therapy for anal cancer
  • Conventional
    • Cross-sectional analysis of patients receiving conventional radiotherapy

Clinical Trial Outcome Measures

Primary Measures

  • Functional quality of life after chemoradiotherapy for anal cancer
    • Time Frame: 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 Measures

  • Patient-reported treatment-related toxicity after chemoradiotherapy for anal cancer
    • Time Frame: 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)

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Cambridge University Hospitals NHS Foundation Trust
  • Collaborator
    • The Christie NHS Foundation Trust
  • Provider of Information About this Clinical Study
    • Principal Investigator: Adam Stearns, Specialist Registrar in Surgery – Cambridge University Hospitals NHS Foundation Trust
  • Overall Contact(s)
    • Adam Stearns, MA DPhil BMBCh MRCS, 01603286286

References

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. Epub 2006 Dec 26.

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.

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