Anal Cancer Radiotherapy Study (ANCARAD)

April 2, 2024 updated by: Marianne Grønlie Guren, Oslo University Hospital

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.

Study Overview

Status

Active, not recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

75

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Oslo, Norway
        • Oslo University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Patients with anal cancer to be treated with radiotherapy or chemoradiotherapy

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

- Cognitive or physical condition resulting in inability to sign informed consent or cooperation during treatment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Disease-free survival
Time Frame: 3 years
3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prediction of local recurrence
Time Frame: 2 years
2 years
Biomarker ability to predict local recurrence rate
Time Frame: 5 years
Substudy will analyze biomarkers in tissue/blood that may predict poor radiotherapy response or local recurrence.
5 years
Improvement of faecal incontinence
Time Frame: 5 years
5 years
Pain relief of palliative radiotherapy
Time Frame: 5 years
Substudy will prospectively evaluate relief of pain and other symptoms of anal cancer after completion of palliative radiotherapy.
5 years

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival
Time Frame: 5 years
5 years
Disease-free survival
Time Frame: 5 years
5 years
Tumor regression
Time Frame: 5 years
5 years
PET and MRI prediction of local tumor control
Time Frame: 5 years
Substudy will analyze PET and MRI at baseline and during treatment, for the ability to predict poor radiotherapy response or local recurrence rate.
5 years
To identify biomarkers predictive of treatment response or late effects
Time Frame: 5 years
5 years
Prevalence and severity of late effects in follow-up; fatigue, faecal incontinence, sexual dysfunction, health-related quality of life. Effect of intervention.
Time Frame: 5 years
5 years
Duration of symptom relief of palliative radiotherapy
Time Frame: 5 years
5 years
Local recurrence rate
Time Frame: 5 years
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oslo University Hospital

Investigators

  • Principal Investigator: Marianne G Guren, MD, PhD, Oslo University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 4, 2013

Primary Completion (Actual)

September 1, 2022

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

August 28, 2013

First Submitted That Met QC Criteria

September 4, 2013

First Posted (Estimated)

September 10, 2013

Study Record Updates

Last Update Posted (Actual)

April 3, 2024

Last Update Submitted That Met QC Criteria

April 2, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2012/2274

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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