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Anal Cancer Radiotherapy Study (ANCARAD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01937780
Recruitment Status : Active, not recruiting
First Posted : September 10, 2013
Last Update Posted : February 24, 2021
Information provided by (Responsible Party):
Marianne Grønlie Guren, Oslo University Hospital

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.

Condition or disease
Anal Cancer

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Study Type : Observational
Estimated Enrollment : 75 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Anal Cancer Radiotherapy - Prospective Study of Treatment Outcome, Patient-Reported Outcomes, Utility of Imaging and Biomarkers, and Cancer Survivorship
Actual Study Start Date : October 4, 2013
Estimated Primary Completion Date : September 2021
Estimated Study Completion Date : January 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anal Cancer

Primary Outcome Measures :
  1. Disease-free survival [ Time Frame: 3 years ]

Secondary Outcome Measures :
  1. Prediction of local recurrence [ Time Frame: 2 years ]
  2. 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.

  3. Improvement of faecal incontinence [ Time Frame: 5 years ]
  4. 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.

Other Outcome Measures:
  1. Tumor regression [ Time Frame: 5 years ]
  2. 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.

  3. To identify biomarkers predictive of treatment response or late effects [ Time Frame: 5 years ]
  4. 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. Duration of symptom relief of palliative radiotherapy [ Time Frame: 5 years ]
  6. Local recurrence rate [ Time Frame: 5 years ]
  7. Disease-free survival [ Time Frame: 5 years ]
  8. Overall survival [ Time Frame: 5 years ]

Biospecimen Retention:   Samples With DNA
Tissue and blood specimens

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with anal cancer to be treated with radiotherapy or chemoradiotherapy

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01937780

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Oslo University Hospital
Oslo, Norway
Sponsors and Collaborators
Oslo University Hospital
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Principal Investigator: Marianne G Guren, MD, PhD Oslo University Hospital
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Responsible Party: Marianne Grønlie Guren, MD PhD, Oslo University Hospital Identifier: NCT01937780    
Other Study ID Numbers: 2012/2274
First Posted: September 10, 2013    Key Record Dates
Last Update Posted: February 24, 2021
Last Verified: February 2021
Additional relevant MeSH terms:
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Anus Neoplasms
Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Anus Diseases
Rectal Diseases