Feasibility of CBCT-Guided Online Adaptive Radiotherapy (FASCINATE)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorThe Netherlands Cancer Institute
About this trial
The accuracy of radiotherapy can be increased by correcting for geometric uncertainties and changes between radiotherapy fractions. These corrections are currently done with online adaptive treatment on a specialized linear accelerator (linac) for a small subset of patients. However, patients currently treated on a standard linac could also benefit from online adaptive radiotherapy. The objective is to determine the feasibility of online CBCT-guided adaptive radiation therapy on a standard Elekta linac.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patient, age ≥ 18 years, referred for a radiotherapy schedule as described in one of the cohorts.
WHO performance score 0-3.
Provision of signed, written and dated IC prior to any study specific procedures.
Accepted for radiotherapy of the prostate and pelvic lymph node areas.
Disqualifiers
Patients who are pregnant.
Patients with a medical condition that severely compromises CBCT image quality (mainly hip prostheses).
Severe lower urinary tract symptoms that could make the longer treatment time problematic (according to judgement of treating physician).
Patients with a medical condition that severely compromises CBCT image quality (mainly hip prostheses).
Trial design
Design model
Parallel
Treatments tested in this trial
online CBCT-guided adaptive radiation therapy using a new software
DevicePatients are treated in the NKI with CBCT-guided online adaptive radiotherapy. While in the clinical workflow one planning CT is used to make the radiotherapy plan, this study treatment creates a new radiotherapy plan on the day of every treatment fraction. Instead of directly irradiating, the radiotherapy plan is adjusted to the anatomy of the day.
Treatment groups
100 Participants
are divided into 5 treatment groupsGroup A: Adapt to rotation for prostate and elective lymph node irradiationExperimental treatment 1 intervention
Group B: CBCT-guided online adaptation for cervical cancer and elective lymph node irradiationExperimental treatment 1 intervention
Group C: CBCT-guided online adaptation for bladder cancer.Experimental treatment 1 intervention
Group D: CBCT-guided online adaptation for lung cancerExperimental treatment 1 intervention
Group E: CBCT-guided online adaptation for head and neck cancerExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Feasibility: successful application of the online adaptive treatment in 90% of 20 patients
The adaptive treatment is feasible if the technique is successfully ap-plied in 90% of 20 patients.
Time frame
From first fraction until the last fraction, an average of 20-35 fractionsSecondary outcomes
1
Safety: Treatment associated ≥ grade 3 acute toxicity according to the NCI Common Terminology Criteria of Adverse Events (CTCAE version 5.0).
Treatment associated ≥ grade 3 acute toxicity according to the NCI Common Terminology Criteria of Adverse Events (CTCAE version 5.0).
Time frame
From Baseline until 3 months after the last radiotherapy fractionSponsors and contacts
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Source ClinicalTrials.gov