Re-optimization Based Online Adaptive Radiotherapy of Anal Cancer

Recruiting

• Conditions: Anal Cancer; Anal Squamous Cell Carcinoma; Anal Carcinoma
• Interventions: Radiation: online adaptive radiotherapy

• Registration Number: NCT05438836
• Lead Sponsor: 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).

Detailed Description

Not available

Study Timeline

• Study Start: 2022-01-01
• Study First Submitted: 2022-06-27
• Study First Submitted QC: 2022-06-27
• Study First Posted: 2022-06-30
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-21
• Last Update Posted: 2023-09-25
• Primary Completion: 2026-01-01
• Study Completion: 2031-01-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 205

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Online adaptive radiotherapy	online adaptive radiotherapy	Daily online adaptive radiotherapy

Primary Outcome Measures

Name	Time	Method
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	percentage of patients with grade 2 or more early treatment-related Gastrointestinal-toxicity

Secondary Outcome Measures

Name	Time	Method
Treatment Related Hospitalization	From of start of radiation therapy through 5 year follow-up	Hospitalization due to radiation therapy treatment related toxicity
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	percentage of patients with grade 2 or more early treatment-related toxicity
Patient Reported Outcomes (PRO)	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
All Late Common Terminology Criteria for Adverse Events (CTCAE) Treatment Related Toxicities	From 3 months after end of treatment to 5 years follow-up	percentage of patients with grade 2 or more late treatment-related toxicity
Disease Free Survival	From time of inclusion to death from bladder cancer, assessed up to 5 years follow-up	Disease Free Survival
Progression Free Survival	From time of inclusion to disease progression, assessed up to 5 years follow-up	Progression free survival (from time of inclusion to disease progression)
Overall Survival	From time of inclusion to death from any cause, assessed up to 5 years follow-up	Overall survival
European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Assessment	from baseline to 5 years follow-up	Collection ofEuropean Organisation for Research and Treatment of Cancer (EORTC) Quality of life questionnaire C30

Trial Locations

Locations (1)

Oncology dept, Herlev and Gentofte Hospital; 🇩🇰 Herlev, Denmark