ROAR-A: re-optimization based Online Adaptive Radiotherapy of anal cancer, a prospective phase II trial protocol.
Katrine Smedegaard Storm, Lina M Åström, Patrik Sibolt...
https://pubmed.ncbi.nlm.nih.gov/38528456Actively Recruiting
Age: 18Years +
All Genders
ID05438836
ROAR-A: Re-optimization Based Online Adaptive Radiotherapy of Anal Cancer
Led by Herlev Hospital · Updated on 2023-09-25
205
Participants Needed
1
Research Sites
260 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating if daily online adaptive radiotherapy for anal cancer can reduce early gastrointestinal side effects compared to the usual non-adaptive intensity modulated radiation therapy (IMRT). This single-arm, prospective Phase II trial is conducted at a single center and aims to improve treatment tolerability for patients with anal cancer. Participants will receive daily online adaptive radiotherapy, which adjusts treatment based on daily imaging to better target the tumor and spare healthy tissue. This approach is compared to the standard non-adaptive Image-Guided Radiotherapy (IGRT) used historically. The trial focuses on the early treatment period and continues monitoring for longer-term effects. During the study, researchers will assess gastrointestinal toxicity from mid-treatment through three months after therapy ends. They will also monitor all treatment-related side effects up to five years, along with patient-reported outcomes and quality of life measures. The trial will track progression-free survival, overall survival, disease-free survival, and any hospitalizations related to treatment over five years, with participation lasting up to that time frame.
CONDITIONS
Brief Title
Re-optimization Based Online Adaptive Radiotherapy of Anal Cancer
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Biopsy-verified anal cancer
- Eligible for curative intended radiotherapy
- Written and oral consent
You will not qualify if you...
- Other malignant disease within the past 5 years (excluding basal cell carcinoma)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Duration of radiotherapy treatment as prescribed
Participants receive daily online adaptive radiotherapy for anal cancer.
Daily visits for radiotherapy sessions
Follow-up
Duration - Up to 5 years after treatment ends
Participants are monitored for treatment-related toxicities, quality of life, and survival outcomes.
Regular follow-up visits over 5 years
Trial Site Locations
Total: 1 location
1
Oncology dept, Herlev and Gentofte Hospital
Herlev, Denmark, 2730
Actively Recruiting
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Research Team
E
Eva Serup-Hansen, MD, PhD
K
katrine S storm, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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