Anal Cancer Radiotherapy Study

Active, not recruiting

• Conditions: Anal Cancer

• Registration Number: NCT01937780
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-08-28
• Study First Submitted QC: 2013-09-04
• Study First Posted: 2013-09-10
• Study Start: 2013-10-04
• Primary Completion: 2022-09
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-18
• Last Update Posted: 2025-03-21
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 75

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Disease-free survival	3 years

Secondary Outcome Measures

Name	Time	Method
Improvement of faecal incontinence	5 years
Pain relief of palliative radiotherapy	5 years	Substudy will prospectively evaluate relief of pain and other symptoms of anal cancer after completion of palliative radiotherapy.
Prediction of local recurrence	2 years
Biomarker ability to predict local recurrence rate	5 years	Substudy will analyze biomarkers in tissue/blood that may predict poor radiotherapy response or local recurrence.

Trial Locations

Locations (1)

Oslo University Hospital; 🇳🇴 Oslo, Norway