Anal Cancer Radiotherapy Study

Anal Cancer Clinical Trial

— ANCARAD  

Official title:

Anal Cancer Radiotherapy - Prospective Study of Treatment Outcome, Patient-Reported Outcomes, Utility of Imaging and Biomarkers, and Cancer Survivorship

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01937780
• Other study ID #: 2012/2274
• Status: Active, not recruiting
• Start date: October 4, 2013
• Est. completion date: December 2024

Study information

• Verified date: April 2024
• Source: Oslo University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 75
• Est. completion date: December 2024
• Est. primary completion date: September 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anal Cancer
• Anus Neoplasms

Locations

Country	Name	City	State
Norway	Oslo University Hospital	Oslo

Sponsors (1)

Lead Sponsor	Collaborator
Oslo University Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Tumor regression		5 years
Other	PET and MRI prediction of local tumor control	Substudy will analyze PET and MRI at baseline and during treatment, for the ability to predict poor radiotherapy response or local recurrence rate.	5 years
Other	To identify biomarkers predictive of treatment response or late effects		5 years
Other	Prevalence and severity of late effects in follow-up; fatigue, faecal incontinence, sexual dysfunction, health-related quality of life. Effect of intervention.		5 years
Other	Duration of symptom relief of palliative radiotherapy		5 years
Other	Local recurrence rate		5 years
Other	Disease-free survival		5 years
Other	Overall survival		5 years
Primary	Disease-free survival		3 years
Secondary	Prediction of local recurrence		2 years
Secondary	Biomarker ability to predict local recurrence rate	Substudy will analyze biomarkers in tissue/blood that may predict poor radiotherapy response or local recurrence.	5 years
Secondary	Improvement of faecal incontinence		5 years
Secondary	Pain relief of palliative radiotherapy	Substudy will prospectively evaluate relief of pain and other symptoms of anal cancer after completion of palliative radiotherapy.	5 years