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Anal Cancer Radiotherapy Study (ANCARAD)

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ClinicalTrials.gov Identifier: NCT01937780
Recruitment Status : Recruiting
First Posted : September 10, 2013
Last Update Posted : September 10, 2013
Sponsor:
Information provided by (Responsible Party):
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

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
Study Start Date : August 2013
Estimated Primary Completion Date : September 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anal Cancer
U.S. FDA Resources




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

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
Criteria

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 ClinicalTrials.gov identifier (NCT number): NCT01937780


Contacts
Contact: Marianne G Guren, MD, PhD marianne.gronlie.guren@ous-hf.no
Contact: Morten Brændengen, MD, PhD morten.braendengen@ous-hf.no

Locations
Norway
Oslo University Hospital Recruiting
Oslo, Norway
Contact: Marianne G Guren, MD, PhD         
Principal Investigator: Marianne G Guren, MD, PhD         
Sponsors and Collaborators
Oslo University Hospital
Investigators
Principal Investigator: Marianne G Guren, MD, PhD Oslo University Hospital

Responsible Party: Oslo University Hospital
ClinicalTrials.gov Identifier: NCT01937780     History of Changes
Other Study ID Numbers: 2012/2274
First Posted: September 10, 2013    Key Record Dates
Last Update Posted: September 10, 2013
Last Verified: September 2013

Additional relevant MeSH terms:
Anus Neoplasms
Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Anus Diseases
Rectal Diseases