Pelvic Cancer Registry for Online Adapted Radiotherapy
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity Medical Center Goettingen
About this trial
This prospective registry-based trial will include patients with pelvic or thoracic tumors with an indication for radiotherapy treated with oART or IGRT. For the primary endpoint and the secondary clinical endpoints, the trial will compare oART versus IGRT, for technical endpoints the trial will compare the real oART scenario with two virtual (hypothetical) control scenarios.
Primary endpoint:
* 10% reduction in the rate of acute radiotherapy related toxicity (≥ CTCAE II°, v5.0) using oART
Secondary endpoints:
* Clinical endpoints: Tumor control, late toxicities compared to conventional irradiated patients, quality of life and patient-reported outcomes * Technical endpoints: Target volume, target coverage, dose to organs at risk, anatomical variability score
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients with pelvic or thoracic tumors with an indication for radiotherapy
Patient information and declaration of consent
Patients age ≥ 18 years
Disqualifiers
Prior radiotherapy in affected site
Trial population
This study will include patients with pelvic or thoracic tumors with an indication for radiotherapy treated with oART or IGRT.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
846 Participants
are grouped into 2 trial groupsGroup A: oART
Group B: IGRT
Trial outcomes
Primary outcomes
1
Rate of acute radiotherapy related toxicity
10% reduction in the rate of acute radiotherapy related toxicity (≥ CTCAE II°, v5.0) using oART
Time frame
until 12 weeks post RTSponsors and contacts
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Source ClinicalTrials.gov