Re-optimization Based Online Adaptive Radiotherapy of Anal Cancer

Anal Cancer Clinical Trial

— ROAR-A  

Official title:

ROAR-A: Re-optimization Based Online Adaptive Radiotherapy of Anal Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05438836
• Other study ID #: H-21028093
• Status: Recruiting
• Start date: January 1, 2022
• Est. completion date: January 1, 2031

Study information

• Verified date: September 2023
• Source: Herlev Hospital
• Contact: Eva Serup-Hansen, MD, PhD
• Phone: +4538689084
• Email: eva.serup-hansen[@]regionh.dk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

A single-arm, prospective, Phase II, single-center clinical trial that will investigate if daily online adaptive radiotherapy for anal cancer will significantly reduce early treatment-related GI toxicity compared with the historically reported rate for non-adaptive intensity modulated radiation therapy (IMRT).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 205
• Est. completion date: January 1, 2031
• Est. primary completion date: January 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Biopsy-verified anal cancer
• Eligible for curative intended radiotherapy
• Written and oral consent

Exclusion Criteria:

• Other malignant disease within the past 5 years (excluding basal cell carcinoma)

Related Conditions & MeSH terms

• Anal Cancer
• Anal Carcinoma
• Anal Squamous Cell Carcinoma
• Anus Neoplasms
• Carcinoma

Intervention

Radiation:
• online adaptive radiotherapy
Online adaptive radiotherapy compared to standard non-adaptive Image-Guided Radiotherapy

Locations

Country	Name	City	State
Denmark	Oncology dept, Herlev and Gentofte Hospital	Herlev

Sponsors (1)

Lead Sponsor	Collaborator
Herlev Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Early Rate of Common Terminology Criteria for Adverse Events (CTCAE) Gastrointestinal Toxicity grade 2 or more (scale from 0-5, 5 being the highest)	percentage of patients with grade 2 or more early treatment-related Gastrointestinal-toxicity	from mid-treatment to 3 months after end of treatment
Secondary	All Early Common Terminology Criteria for Adverse Events (CTCAE) Treatment Related Toxicities. Grade 1-5 (5 being the highest)	percentage of patients with grade 2 or more early treatment-related toxicity	from mid-treatment to 3 months after end of treatment
Secondary	All Late Common Terminology Criteria for Adverse Events (CTCAE) Treatment Related Toxicities	percentage of patients with grade 2 or more late treatment-related toxicity	From 3 months after end of treatment to 5 years follow-up
Secondary	Patient Reported Outcomes (PRO)	Collection of National Cancer Institute Patient Reported Outcome-Common Terminology Criteria for Adverse Events (NCI PRO-CTCAE) questionnaire (scale from none to a lot) and comparison to Common Terminology Criteria for Adverse Events (CTCAE) and dosimetry data	from baseline to 5 years follow-up
Secondary	European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Assessment	Collection ofEuropean Organisation for Research and Treatment of Cancer (EORTC) Quality of life questionnaire C30	from baseline to 5 years follow-up
Secondary	Progression Free Survival	Progression free survival (from time of inclusion to disease progression)	From time of inclusion to disease progression, assessed up to 5 years follow-up
Secondary	Overall Survival	Overall survival	From time of inclusion to death from any cause, assessed up to 5 years follow-up
Secondary	Disease Free Survival	Disease Free Survival	From time of inclusion to death from bladder cancer, assessed up to 5 years follow-up
Secondary	Treatment Related Hospitalization	Hospitalization due to radiation therapy treatment related toxicity	From of start of radiation therapy through 5 year follow-up