Re-optimization Based Online Adaptive Radiotherapy of Anal Cancer

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

Sponsors

Lead Sponsor: Herlev Hospital

Source Herlev Hospital
Brief 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).

Overall Status Recruiting
Start Date 2022-01-01
Completion Date 2031-01-01
Primary Completion Date 2026-01-01
Phase Phase 2
Study Type Interventional
Primary Outcome
Measure 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) from mid-treatment to 3 months after end of treatment
Secondary Outcome
Measure Time Frame
All Early Common Terminology Criteria for Adverse Events (CTCAE) Treatment Related Toxicities. Grade 1-5 (5 being the highest) from mid-treatment to 3 months after end of treatment
All Late Common Terminology Criteria for Adverse Events (CTCAE) Treatment Related Toxicities From 3 months after end of treatment to 5 years follow-up
Patient Reported Outcomes (PRO) from baseline to 5 years follow-up
European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Assessment from baseline to 5 years follow-up
Progression Free Survival From time of inclusion to disease progression, assessed up to 5 years follow-up
Overall Survival From time of inclusion to death from any cause, assessed up to 5 years follow-up
Disease Free Survival From time of inclusion to death from bladder cancer, assessed up to 5 years follow-up
Treatment Related Hospitalization From of start of radiation therapy through 5 year follow-up
Enrollment 205
Condition
Intervention

Intervention Type: Radiation

Intervention Name: online adaptive radiotherapy

Description: Online adaptive radiotherapy compared to standard non-adaptive Image-Guided Radiotherapy

Arm Group Label: Online adaptive radiotherapy

Other Name: Varian Ethos Adaptive Radiation Therapy

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)

Gender:

All

Minimum Age:

18 Years

Maximum Age:

N/A

Healthy Volunteers:

No

Overall Official
Last Name Role Affiliation
Eva S Serup-Hansen, MD, PhD Principal Investigator Herlev og Gentofte Hospital
Overall Contact

Last Name: Eva Serup-Hansen, MD, PhD

Phone: +4538689084

Email: [email protected]

Location
Facility: Status: Contact: Contact Backup: Investigator: Oncology dept, Herlev and Gentofte Hospital Eva S Serup-Hansen, MD, PhD +4538689084 [email protected] Eva Serup-Hansen, MD, PhD Principal Investigator katrine S Storm, MD Sub-Investigator Anna-Lene Fromm, MD Sub-Investigator Laura V Diness, MD Sub-Investigator
Location Countries

Denmark

Verification Date

2022-08-01

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Herlev Hospital

Investigator Full Name: Eva Serup-Hansen

Investigator Title: Clinical oncologist, MD, PhD

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 1
Arm Group

Label: Online adaptive radiotherapy

Type: Experimental

Description: Daily online adaptive radiotherapy

Acronym ROAR-A
Patient Data Undecided
Study Design Info

Allocation: N/A

Intervention Model: Single Group Assignment

Primary Purpose: Treatment

Masking: None (Open Label)

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