Anal Cancer Radiotherapy Study

Overview

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.

Full Title of Study: “Anal Cancer Radiotherapy – Prospective Study of Treatment Outcome, Patient-Reported Outcomes, Utility of Imaging and Biomarkers, and Cancer Survivorship”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: September 2021

Clinical Trial Outcome Measures

Primary Measures

  • Disease-free survival
    • Time Frame: 3 years

Secondary Measures

  • 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.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Oslo University Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: Marianne Grønlie Guren, MD PhD – Oslo University Hospital
  • Overall Official(s)
    • Marianne G Guren, MD, PhD, Principal Investigator, Oslo University Hospital

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