Anal CancerANCARADNCT01937780
Anal Cancer Radiotherapy Study
An observational study of Anal Cancer, run by Oslo University Hospital at 1 site in Norway.
Trial summary
This is a prospective study of patients receiving radiotherapy or chemoradiotherapy for anal cancer. Treatment effect in terms of survival and local recurrence will be analyzed. The utility of PET-CT and MRI for radiotherapy and for prediction of treatment effect will be investigated. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anal Cancer
- How many people
- 75 participants
- Where
- 1 siteNorway
- Study dates
- 4 Oct 2013to May 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 with anal cancer to be treated with radiotherapy or chemoradiotherapy
Who may be able to join
- Histologically verified anal squamous cell carcinoma
- Radiotherapy or chemoradiotherapy planned
- ECOG performance status 0-2
- >= 18 years of age
- Signed informed consent and expected cooperation of the patients for treatment and follow up
Who cannot join
- Cognitive or physical condition resulting in inability to sign informed consent or cooperation during treatment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Anal Cancer Radiotherapy - Prospective Study of Treatment Outcome, Patient-Reported Outcomes, Utility of Imaging and Biomarkers, and Cancer Survivorship
This is a prospective study of patients receiving radiotherapy or chemoradiotherapy for anal cancer. Treatment effect in terms of survival and local recurrence will be analyzed. The utility of PET-CT and MRI for radiotherapy and for prediction of treatment effect will be investigated. Molecular and genetic markers in tumor and blood will be analyzed for prognostic and predictive effects. Patient-reported outcomes, such as faecal incontinence, sexual dysfunction and quality of life will be assessed. A structured intervention program for management of late effects will be evaluated. Symptom relief of palliative radiotherapy will be investigated. The main purpose of the study is to increase the knowledge of anal cancer treatment, improve treatment results, and improve anal cancer survivor care.
- Conditions
- Anal Cancer
- Medical subject headings
- Anus Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease-free survival
Measured: 3 years
Secondary outcomes (4)
Prediction of local recurrence
Measured: 2 years
Biomarker ability to predict local recurrence rate
Substudy will analyze biomarkers in tissue/blood that may predict poor radiotherapy response or local recurrence.
Measured: 5 years
Improvement of faecal incontinence
Measured: 5 years
Pain relief of palliative radiotherapy
Substudy will prospectively evaluate relief of pain and other symptoms of anal cancer after completion of palliative radiotherapy.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2013 (estimated)
- Study start4 Oct 2013
- Primary completionSep 2022
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Anal CancerStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- 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
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marianne Grønlie Guren, Oslo University Hospital
- Investigators
- Marianne G Guren, MD, PhD, Principal investigator, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01937780
- Sponsor's protocol ID
- 2012/2274
- Acronym
- ANCARAD
- Status last verified
- Oct 2026
- First submitted
- 28 Aug 2013
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
Publications
Hanekamp BA, Viktil E, Dormagen JB, Klow NE, Brunborg C, Malinen E, Guren MG, Schulz A. Optimal time for MRI response evaluation in squamous cell carcinoma of the anus. BJR Open. 2026 Feb 11;8(1):tzag004. doi: 10.1093/bjro/tzag004. eCollection 2026 Jan.
PubMed 41768146
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anal Cancer Radiotherapy - Prospective Study of Treatment Outcome, Patient-Reported Outcomes, Utility of Imaging and Biomarkers, and Cancer Survivorship
- ClinicalTrials.gov ID
- NCT01937780
- Acronym / sponsor ID
- ANCARAD / 2012/2274
- Conditions
- Anal Cancer
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Study start
- 4 Oct 2013 (actual)
- Primary completion
- Sep 2022 (actual)
- Study completion
- May 2027 (estimated)
- First posted
- 10 Sep 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.
This is a prospective study of patients receiving radiotherapy or chemoradiotherapy for anal cancer. Treatment effect in terms of survival and local recurrence will be analyzed. The utility of PET-CT and MRI for radiotherapy and for prediction of treatment effect will be investigated. Molecular and genetic markers in tumor and blood will be analyzed for prognostic and predictive effects. Patient-reported outcomes, such as faecal incontinence, sexual dysfunction and quality of life will be assessed. A structured intervention program for management of late effects will be evaluated. Symptom relief of palliative radiotherapy will be investigated. The main purpose of the study is to increase the knowledge of anal cancer treatment, improve treatment results, and improve anal cancer survivor care.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with anal cancer to be treated with radiotherapy or chemoradiotherapy
Key inclusion criteria (5 listed)
- Histologically verified anal squamous cell carcinoma
- Radiotherapy or chemoradiotherapy planned
- ECOG performance status 0-2
- >= 18 years of age
- Signed informed consent and expected cooperation of the patients for treatment and follow up
Key exclusion criteria (1 listed)
- Cognitive or physical condition resulting in inability to sign informed consent or cooperation during treatment
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
Disease-free survival
Time frame: 3 years
4 secondary outcomes
Prediction of local recurrence
Time frame: 2 years
Biomarker ability to predict local recurrence rate
Time frame: 5 years
Improvement of faecal incontinence
Time frame: 5 years
Pain relief of palliative radiotherapy
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2026.
- Derived from this study: PubMed 41768146Hanekamp BA, Viktil E, Dormagen JB, Klow NE, Brunborg C, Malinen E, Guren MG, Schulz A. Optimal time for MRI response evaluation in squamous cell carcinoma of the anus. BJR Open. 2026 Feb 11;8(1):tzag004. doi: 10.1093/bjro/tzag004. eCollection 2026 Jan.
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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.
Marianne G Guren, MD, PhD principal investigator
Oslo University Hospital
1 site 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 Oslo University Hospital at 1 site in Norway.
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 5 inclusion and 1 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: under way, not looking for participants, as of the sponsor's last update on 20 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease-free survival (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 NCT01937780, which also lists 1 linked publication.
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 20 Oct 2026.