Re-optimization Based Online Adaptive Radiotherapy of Anal Cancer
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorHerlev Hospital
About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Biopsy-verified anal cancer
Eligible for curative intended radiotherapy
Written and oral consent
Disqualifiers
Other malignant disease within the past 5 years (excluding basal cell carcinoma)
Trial population
Patients with non-metastatic squamous cell carcinoma of the anus, referred for chemo-radiotherapy with curative intent.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
online adaptive radiotherapy
RadiationOnline adaptive radiotherapy compared to standard non-adaptive Image-Guided Radiotherapy
Treatment groups
205 Participants
are divided into 1 treatment groupGroup A: Online adaptive radiotherapy1 intervention
Trial outcomes
Primary outcomes
1
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
Time frame
from mid-treatment to 3 months after end of treatmentSecondary outcomes
1
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 treatment2
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-up3
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-up4
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-upSponsors and contacts
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Source ClinicalTrials.gov