Re-optimization Based Online Adaptive Radiotherapy of Anal Cancer

Study Overview
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Brief Summary
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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).

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

Conditions
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Anal Cancer, Anal Carcinoma, Anal Squamous Cell Carcinoma

Intervention / Treatment
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* Radiation: online adaptive radiotherapy


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Online adaptive radiotherapy<br>Daily online adaptive radiotherapy | Radiation: online adaptive radiotherapy<br>* Online adaptive radiotherapy compared to standard non-adaptive Image-Guided Radiotherapy<br>* Other names: Varian Ethos Adaptive Radiation Therapy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| Overall Survival | Overall survival | From time of inclusion to death from any cause, assessed up to 5 years follow-up | 
| Disease Free Survival | Disease Free Survival | From time of inclusion to death from bladder cancer, assessed up to 5 years follow-up | 
| Treatment Related Hospitalization | Hospitalization due to radiation therapy treatment related toxicity | From of start of radiation therapy through 5 year follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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adaptive radiotherapy, Anal cancer, Online Adaptive radiotherapy (oART)