NCT Number: NCT05438836
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).
Interested in participating?
Request Info18 year and older
All sexes
Observational
Herlev, 2730, Denmark
Location status: Recruiting
Anna-Lene Fromm, MD
SUB_INVESTIGATOR
Eva S Serup-Hansen, MD, PhD
CONTACT
Eva Serup-Hansen, MD, PhD
PRINCIPAL_INVESTIGATOR
Laura V Diness, MD
SUB_INVESTIGATOR
katrine S Storm, MD
SUB_INVESTIGATOR
katrine s Storm, MD
CONTACT
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Online adaptive radiotherapy compared to standard non-adaptive Image-Guided Radiotherapy
Other names: Varian Ethos Adaptive Radiation Therapy
Time frame: from mid-treatment to 3 months after end of treatment
percentage of patients with grade 2 or more early treatment-related Gastrointestinal-toxicity
Time frame: from mid-treatment to 3 months after end of treatment
percentage of patients with grade 2 or more early treatment-related toxicity
Time frame: From 3 months after end of treatment to 5 years follow-up
percentage of patients with grade 2 or more late treatment-related toxicity
Time frame: from baseline to 5 years follow-up
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
Time frame: from baseline to 5 years follow-up
Collection ofEuropean Organisation for Research and Treatment of Cancer (EORTC) Quality of life questionnaire C30
Time frame: From time of inclusion to disease progression, assessed up to 5 years follow-up
Progression free survival (from time of inclusion to disease progression)
Time frame: From time of inclusion to death from any cause, assessed up to 5 years follow-up
Overall survival
Time frame: From time of inclusion to death from bladder cancer, assessed up to 5 years follow-up
Disease Free Survival
Time frame: From of start of radiation therapy through 5 year follow-up
Hospitalization due to radiation therapy treatment related toxicity
Contact information is provided by the study sponsor or research team.
Eva Serup-Hansen, MD, PhD
CONTACT
katrine S storm, MD
CONTACT
Herlev Hospital
Other
ROAR-A: Re-optimization Based Online Adaptive Radiotherapy of Anal Cancer
Acronym: ROAR-A
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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