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).
Study Type
OBSERVATIONAL
Enrollment
205
Online adaptive radiotherapy compared to standard non-adaptive Image-Guided Radiotherapy
Oncology dept, Herlev and Gentofte Hospital
Herlev, Denmark
RECRUITINGEarly 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
Time frame: from mid-treatment to 3 months after end of treatment
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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: from baseline to 5 years follow-up
Progression Free Survival
Progression free survival (from time of inclusion to disease progression)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: From time of inclusion to disease progression, assessed up to 5 years follow-up
Overall Survival
Overall survival
Time frame: From time of inclusion to death from any cause, assessed up to 5 years follow-up
Disease Free Survival
Disease Free Survival
Time frame: 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
Time frame: From of start of radiation therapy through 5 year follow-up