NCT01853059

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
176

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2013

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 10, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 14, 2013

Completed
5 months until next milestone

Study Start

First participant enrolled

October 1, 2013

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2017

Completed
Last Updated

May 15, 2013

Status Verified

May 1, 2013

Enrollment Period

4 years

First QC Date

May 10, 2013

Last Update Submit

May 13, 2013

Conditions

Anal Cancer

Keywords

Anal cancerSquamous cell cancerRadiotherapyChemoradiotherapyConformational radiotherapyIntensity modulated radiation therapyIMRT

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Patient-reported treatment-related toxicity after chemoradiotherapy for anal cancer

    3 years

Study Arms (2)

IMRT

Prospective longitudinal assessment of patients receiving intensity-modulated radiation therapy for anal cancer

Conventional

Cross-sectional analysis of patients receiving conventional radiotherapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients under the care of the anal cancer multidisciplinary team in Addenbrookes, Cambridge and Christie Hospital, Manchester

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Addenbrookes Hospital

Cambridge, CB2 0QQ, United Kingdom

Location

Christie Hospital

Manchester, M20 4BX, United Kingdom

Location

Related Publications (3)

  • 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.

    PMID: 20492729BACKGROUND

  • 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.

    PMID: 17189954BACKGROUND

  • 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.

    PMID: 22633812BACKGROUND

MeSH Terms

Conditions

Anus NeoplasmsNeoplasms, Squamous Cell

Condition Hierarchy (Ancestors)

Rectal NeoplasmsColorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesIntestinal DiseasesAnus DiseasesRectal DiseasesNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Central Study Contacts

Adam Stearns, MA DPhil BMBCh MRCS

CONTACT

01603286286

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Specialist Registrar in Surgery

Study Record Dates

First Submitted

May 10, 2013

First Posted

May 14, 2013

Study Start

October 1, 2013

Primary Completion

October 1, 2017

Study Completion

October 1, 2017

Last Updated

May 15, 2013

Record last verified: 2013-05

Locations

GB(2)