Pelvic Cancer Registry for Online Adapted Radiotherapy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Pelvic Tumor, Thoracic Tumor. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Germany
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Pelvic and Thoracic Cancer Treated With Online Adapted Radiotherapy: A Prospective Registry-based Phase-II Trial
Overview
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
Detailed description
Background: Conventional Radiotherapy (Image Guided Radiotherapy, IGRT) requires a CT-based treatment planning process a priori. During this process, a treatment plan is calculated, which then is applied to the patient with a linear accelerator on a daily basis, possibly using image guidance to account for variability in patient position. However, daily changes of the anatomy of targets and organs at risk (OARs) can only be addressed by applying additional safety margins, resulting in larger irradiated volumes and possibly higher toxicity.
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
Primary outcome measures
- Rate of acute radiotherapy related toxicity [Time frame: until 12 weeks post RT]
Eligibility criteria
Inclusion criteria
- Patients with pelvic or thoracic tumors with an indication for radiotherapy
- Patient information and declaration of consent
- Patients age ≥ 18 years
Exclusion criteria
- Prior radiotherapy in affected site
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Germany · 1 center
- University Medical Center, Departement of Radiation Oncology — Göttingen
Publications
- Fischer LA, Fischer J, Scheele NC, Droege LH, Leu M, Guhlich M, Oelmann-Avendano JT, Hille A, Bendrich S, Donath S, Knaus O, Ziegler DA, Zwerenz CM, Anczykowski MZ, Ammon HE, Luise Bergau PF, Pagel CF, Schirmer MA, Wenzel AR, Frohn J, Bensberg J, Strauss A, Asendorf T, Schmitt D, Rieken S, El Shafie RA. Online adaptive radiotherapy in pelvic and thoracic cancers - comparing toxicities, clinical ou PMID 42557552
Identifiers
NCT: NCT06185062 · 2023-02727