Anal Cancer Radiotherapy Study
ANCARAD
Anal Cancer Radiotherapy - Prospective Study of Treatment Outcome, Patient-Reported Outcomes, Utility of Imaging and Biomarkers, and Cancer Survivorship
1 other identifier
observational
75
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Oct 2013
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 28, 2013
CompletedFirst Posted
Study publicly available on registry
September 10, 2013
CompletedStudy Start
First participant enrolled
October 4, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2025
CompletedMarch 21, 2025
March 1, 2025
8.9 years
August 28, 2013
March 18, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Disease-free survival
3 years
Secondary Outcomes (4)
Prediction of local recurrence
2 years
Biomarker ability to predict local recurrence rate
5 years
Improvement of faecal incontinence
5 years
Pain relief of palliative radiotherapy
5 years
Other Outcomes (8)
Tumor regression
5 years
PET and MRI prediction of local tumor control
5 years
To identify biomarkers predictive of treatment response or late effects
5 years
- +5 more other outcomes
Eligibility Criteria
Patients with anal cancer to be treated with radiotherapy or chemoradiotherapy
You may qualify if:
- 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
You may not qualify if:
- \- Cognitive or physical condition resulting in inability to sign informed consent or cooperation during treatment
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Oslo University Hospital
Oslo, Norway
Biospecimen
Tissue and blood specimens
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Marianne G Guren, MD, PhD
Oslo University Hospital
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD PhD
Study Record Dates
First Submitted
August 28, 2013
First Posted
September 10, 2013
Study Start
October 4, 2013
Primary Completion
September 1, 2022
Study Completion
December 1, 2025
Last Updated
March 21, 2025
Record last verified: 2025-03