Clinical Trial: Anal Cancer Radiotherapy Study
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational
Official Title: Anal Cancer Radiotherapy - Prospective Study of Treatment Outcome, Patient-Reported Outcomes, Utility of Imaging and Biomarkers, and Cancer Survivorship
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.
Detailed Summary:
Sponsor: Oslo University Hospital
Current Primary Outcome: Disease-free survival [ Time Frame: 3 years ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Prediction of local recurrence [ Time Frame: 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.
- Improvement of faecal incontinence [ Time Frame: 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.
Original Secondary Outcome: Same as current
Information By: Oslo University Hospital
Dates:
Date Received: August 28, 2013
Date Started: August 2013
Date Completion:
Last Updated: September 4, 2013
Last Verified: September 2013
