Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
846 participants
OBSERVATIONAL
2024-01-01
2030-04-30
Brief Summary
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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
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Detailed Description
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A promising and innovative technique for margin and in consequence toxicity reduction is online Adaptive Radiotherapy (oART) using daily imaging to create a "plan of the day" aligned to the actual anatomy by means of artificial intelligence (AI) and with the patient on the treatment couch. This approach is especially promising in the pelvic region due to the high anatomic variability, e.g. caused by peristalsis or volume changes of bladder and rectum. Furthermore, the application of oART in the field of thoracic tumors is being evaluated. oART is an already established form of treatment which is used regulary everyday in clinical practice and is not a study-related intervention. A direct comparison of both techniques IGRT vs. oART is missing.
Methods: This prospective and retrospective 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 as follows:
* oART - Applied treatment: AI-based daily treatment plan creation, adapted to daily anatomy
* Virt 1 - Hypothetical dose distribution of initial treatment plan, based on the initial planning CT
* Virt 2 - Hypothetical dose distribution of initial treatment plan, applied to the anatomy of the day as depicted by cone-beam CT at the treatment machine
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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oART
Patients with pelvic or thoracic tumors with an indication for radiotherapy treated with oART (online Adaptied Radiotherapy).
No interventions assigned to this group
IGRT
Patients with pelvic or thoracic tumors with an indication for radiotherapy treated with conventional IGRT (Image Guided Radiotherapy).
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Patient information and declaration of consent
* Patients age ≥ 18 years
Exclusion Criteria
18 Years
ALL
No
Sponsors
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University Medical Center Goettingen
OTHER
Responsible Party
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Prof. Dr. Rami El Shafie
Clinical Study Management on behalf of the Principal Investigator
Locations
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University Medical Center, Departement of Radiation Oncology
Göttingen, , Germany
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2023-02727
Identifier Type: -
Identifier Source: org_study_id
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