Abdominal Tumor, Pelvic Tumor
Conditions
Keywords
adaptive radiotherapy, stereotactic body radiotherapy, SBRT, MR-guided radiotherapy
Brief summary
SBRT delivers high-dose radiation to precisely defined target volumes and is an effective locally ablative treatment option for both primary tumours and oligometastases in various settings, including lesions in the abdomen or pelvis. However, SBRT in these regions faces considerable challenges such as inter-fractional organ motion and anatomical deformation, which can compromise treatment precision. MR-guided SBRT offers a solution, providing superior soft-tissue contrast and enabling real-time, online treatment plan adaptation over the course of SBRT. This approach reduces the risk of geographical miss and overdose to adjacent, vulnerable OARs. Currently, MR-guided SBRT uses a fixed dose per fraction, only adjusting target volume and OAR contours for anatomical changes when performing plan adaptation. However, overlaps between planning target volumes (PTVs) and dose-limiting OARs regularly require compromises in PTV coverage. To address this, AF aims to also adjust dose per fraction based on daily PTV-OAR overlap. With this approach, more dose is applied on treatment days with less PTV-OAR overlap while less dose is applied on days with more PTV-OAR overlap. This trial assesses the feasibility of AF in MR-guided SBRT for abdominal and pelvic tumours that show PTV-overlap with one or more dose-limiting OARs, ultimately aiming to enhance PTV dose coverage without increasing toxicity.
Interventions
RADIATIONSBRT with adaptive fractionation
The fraction dose to the PTV will be adapted based on the volume overlap of PTV and the dose-limiting OAR(s) (bowel / duodenum / stomach) on the planning MRI scan of the day ("geometry-of-the-day"). The treatment plan is then approved by the treating physician and independently verified according to department-internal standard. MR-guided fraction dose adaptation will be repeated at each of the 5 fractions, until the prescribed total dose is reached.
RADIATIONStandard of Care (SOC)
Patients that qualify for inclusion in the study but for whom AF is no viable treatment due to lacking PTV/OAR overlap in the planning scans. These patients are treated according to clinical standard of care (SoC), i.e. without dose adaptation, and function as a control group.
Sponsors
University of Zurich
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Karnofsky performance status ≥70 * Abdominal or pelvic malignancy (primary or secondary) with previous histological confirmation of the primary tumour, amenable to SBRT in 5 fractions (excluding SBRT to primary tumour in patients with prostate cancer) Note: patients with primary prostate cancer are eligible, but SBRT to the primary tumour in the prostate cannot be performed within the study * Total prescribed SBRT dose \> 30 Gy (constraint for dose-limiting OAR) over 5 treatment fractions * Distance of the GTV ≤ 1 cm from at least one dose-limiting OAR (bowel / duodenum / stomach) in the available diagnostic images * Patients able to tolerate long (approximately 60 minutes) treatment time according to clinical evaluation of the treating radiation oncologist * Patients willing and able to comply with scheduled visits, treatment, and other trial procedures
Exclusion criteria
* Previous radiation therapy directly overlapping with planned SBRT (type I re-irradiation) * More than one PTV irradiated in the same plan * Contraindications for MRI, e.g., patients with metal fragments or implanted devices that are not MR compatible such as certain types of pacemakers and aneurysm clips or severe claustrophobia * SBRT not indicated or not possible * Inability to follow the procedures of the trial, e.g. due to language problems of the participant
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of patients with successful daily dose adaptation | from enrollment to end of treatment at 1-2 weeks | Proportion of patients treated with daily dose-adapted treatment, who received at least one fraction of non-uniformly fractionated treatment with expectation of a benefit in PTV-coverage of ≥ 1ccGy |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Acute treatment toxicities | during treatment (1-2 weeks) and until 90 days after | Acute treatment toxicities for all included patients measured with Common Terminology Criteria for Adverse Events |
| Interfractional variation in PTV/OAR overlap volume | during treatment (1-2 weeks) | interfractional variation in PTV/OAR overlap volume, in cc |
| Interfractional variation in GTV/OAR distance | during treatment (1-2 weeks) | interfractional variation in GTV/OAR distance, in mm |
| Dosimetric difference in PTV-coverage between algorithm-based calculation and the reference plan | after end of treatment (2 weeks after last fraction) | PTV coverage quantified as the area above the dose-volume-histogram curve measured in cc x Gy |
Countries
Switzerland
Contacts
CONTACTJan Unkelbach, Prof. Dr. rer. nat.
CONTACTLena Kretzschmar, Dr. med.
PRINCIPAL_INVESTIGATORReinhardt Krcek, Dr. med.
University of Zurich
Outcome results
None listed