Re-optimization Based Online Adaptive Radiotherapy of Anal Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: online adaptive radiotherapy.
- Who it may be relevant to
- Registry conditions: Anal Cancer, Anal Carcinoma, Anal Squamous Cell Carcinoma. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Denmark
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
ROAR-A: Re-optimization Based Online Adaptive Radiotherapy of Anal Cancer
Overview
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).
Interventions
- Radiation online adaptive radiotherapy
Online adaptive radiotherapy compared to standard non-adaptive Image-Guided Radiotherapy
Primary outcome measures
- Early Rate of Common Terminology Criteria for Adverse Events (CTCAE) Gastrointestinal Toxicity grade 2 or more (scale from 0-5, 5 being the highest) [Time frame: from mid-treatment to 3 months after end of treatment]
Secondary outcome measures (8)
- All Early Common Terminology Criteria for Adverse Events (CTCAE) Treatment Related Toxicities. Grade 1-5 (5 being the highest) [Time frame: from mid-treatment to 3 months after end of treatment]
- All Late Common Terminology Criteria for Adverse Events (CTCAE) Treatment Related Toxicities [Time frame: From 3 months after end of treatment to 5 years follow-up]
- Patient Reported Outcomes (PRO) [Time frame: from baseline to 5 years follow-up]
- European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Assessment [Time frame: from baseline to 5 years follow-up]
- Progression Free Survival [Time frame: From time of inclusion to disease progression, assessed up to 5 years follow-up]
- Overall Survival [Time frame: From time of inclusion to death from any cause, assessed up to 5 years follow-up]
- Disease Free Survival [Time frame: From time of inclusion to death from bladder cancer, assessed up to 5 years follow-up]
- Treatment Related Hospitalization [Time frame: From of start of radiation therapy through 5 year follow-up]
Eligibility criteria
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Denmark · 1 center
- Oncology dept, Herlev and Gentofte Hospital — Herlev
Publications
- Storm KS, Astrom LM, Sibolt P, Behrens CP, Persson GF, Serup-Hansen E. ROAR-A: re-optimization based Online Adaptive Radiotherapy of anal cancer, a prospective phase II trial protocol. BMC Cancer. 2024 Mar 25;24(1):374. doi: 10.1186/s12885-024-12111-1. PMID 38528456
Identifiers
NCT: NCT05438836 · H-21028093