Anal CancerFOFACTNCT01853059
Functional Outcomes Following Anal Cancer Treatment
An observational study of Anal Cancer, run by Cambridge University Hospitals NHS Foundation Trust at 2 sites in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anal Cancer
- How many people
- 176 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- Oct 2013to Oct 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients under the care of the anal cancer multidisciplinary team in Addenbrookes, Cambridge and Christie Hospital, Manchester
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Adam Stearns, MA DPhil BMBCh MRCS contact
United Kingdom2 sites
Addenbrookes Hospital
Cambridge, CB2 0QQ
Adam T Stearns
Nicola Fearnhead
Christie Hospital
Manchester, M20 4BX
Andrew Renehan
Susan Davidson
About this study
Official title: Observational Study of Functional Outcomes After Chemoradiotherapy for Squamous Cell Cancer of the Anus
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.
- Conditions
- Anal Cancer
- Keywords
- Anal cancer, Squamous cell cancer, Radiotherapy, Chemoradiotherapy, Conformational radiotherapy, Intensity modulated radiation therapy, IMRT
- Medical subject headings
- Anus Neoplasms, Neoplasms, Squamous Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| IMRT | Prospective longitudinal assessment of patients receiving intensity-modulated radiation therapy for anal cancer | |
| Conventional | Cross-sectional analysis of patients receiving conventional radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3 years
Secondary outcomes (1)
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)
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2013 (estimated)
- Study startOct 2013
- Primary completionOct 2017 (estimated)
- Study completionOct 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Anal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 176 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cambridge University Hospitals NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- The Christie NHS Foundation Trust, Bowel Disease Research Foundation
- Responsible party
- Principal investigator, Adam Stearns, Cambridge University Hospitals NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01853059
- Sponsor's protocol ID
- A092896
- Acronym
- FOFACT
- Status last verified
- May 2013
- First submitted
- 10 May 2013
- Last updated
- 15 May 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 20492729Brown 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.
PubMed 17189954Barraclough 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.
PubMed 22633812
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study of Functional Outcomes After Chemoradiotherapy for Squamous Cell Cancer of the Anus
- ClinicalTrials.gov ID
- NCT01853059
- Acronym / sponsor ID
- FOFACT / A092896
- Conditions
- Anal Cancer
- Keywords
- Anal cancer, Squamous cell cancer, Radiotherapy, Chemoradiotherapy, Conformational radiotherapy, Intensity modulated radiation therapy, IMRT
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 176 participants (estimated)
- Lead sponsor
- Cambridge University Hospitals NHS Foundation TrustUniversity, hospital or other
- Collaborators
- The Christie NHS Foundation Trust, Bowel Disease Research Foundation
- Study start
- Oct 2013
- Primary completion
- Oct 2017 (estimated)
- Study completion
- Oct 2017 (estimated)
- First posted
- 14 May 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IMRT | – | –Prospective longitudinal assessment of patients receiving intensity-modulated radiation therapy for anal cancer |
| Conventional | – | –Cross-sectional analysis of patients receiving conventional radiotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients under the care of the anal cancer multidisciplinary team in Addenbrookes, Cambridge and Christie Hospital, Manchester
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
1 secondary outcome
Patient-reported treatment-related toxicity after chemoradiotherapy for anal cancer
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2013.
- Background: PubMed 20492729Provencher 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.
- Background: PubMed 17189954Brown 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.
- Background: PubMed 22633812Barraclough 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adam Stearns, MA DPhil BMBCh MRCS contact
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anal Cancer, run by Cambridge University Hospitals NHS Foundation Trust at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 May 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Adam Stearns, MA DPhil BMBCh MRCS (01603286286), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional quality of life after chemoradiotherapy for anal cancer (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01853059, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2013.