Anal Cancer Radiotherapy Study (ANCARAD)

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2013 by Oslo University Hospital
Sponsor:
Information provided by (Responsible Party):
Oslo University Hospital
ClinicalTrials.gov Identifier:
NCT01937780
First received: August 28, 2013
Last updated: September 4, 2013
Last verified: September 2013
  Purpose

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
Anal Cancer

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Oslo University Hospital:

Primary Outcome Measures:
  • Disease-free survival [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Prediction of local recurrence [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Biomarker ability to predict local recurrence rate [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    Substudy will analyze biomarkers in tissue/blood that may predict poor radiotherapy response or local recurrence.

  • Improvement of faecal incontinence [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Pain relief of palliative radiotherapy [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    Substudy will prospectively evaluate relief of pain and other symptoms of anal cancer after completion of palliative radiotherapy.


Other Outcome Measures:
  • Tumor regression [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • PET and MRI prediction of local tumor control [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    Substudy will analyze PET and MRI at baseline and during treatment, for the ability to predict poor radiotherapy response or local recurrence rate.

  • To identify biomarkers predictive of treatment response or late effects [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Duration of symptom relief of palliative radiotherapy [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Local recurrence rate [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Disease-free survival [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Tissue and blood specimens


Estimated Enrollment: 75
Study Start Date: August 2013
Estimated Primary Completion Date: September 2021 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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

  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Oslo University Hospital
ClinicalTrials.gov Identifier: NCT01937780     History of Changes
Other Study ID Numbers: 2012/2274
Study First Received: August 28, 2013
Last Updated: September 4, 2013
Health Authority: Norway: Ethics Committee

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

ClinicalTrials.gov processed this record on August 28, 2014