Daily Adjustment of the Radiation Dose in MRI-guided Stereotactic Radiotherapy for Tumors in the Abdominal and Pelvic Regions

NCT07687147 | Recruiting

• 2 other identifiers: RAO-25-0192026-00067
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Abdominal Tumor; Pelvic Tumor

Keywords

adaptive radiotherapy; stereotactic body radiotherapy; SBRT; MR-guided radiotherapy

Outcome Measures

Primary Outcomes (1)

• Proportion of patients with successful daily dose adaptation

  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

  from enrollment to end of treatment at 1-2 weeks

Secondary Outcomes (4)

• Acute treatment toxicities

  during treatment (1-2 weeks) and until 90 days after

• Interfractional variation in PTV/OAR overlap volume

  during treatment (1-2 weeks)

• Interfractional variation in GTV/OAR distance

  during treatment (1-2 weeks)

• Dosimetric difference in PTV-coverage between algorithm-based calculation and the reference plan

  after end of treatment (2 weeks after last fraction)

Study Arms (2)

RT with AF

EXPERIMENTAL

Patients with PTV/OAR overlap will receive AF, with dose adapted daily based on anatomy.

Radiation: SBRT with adaptive fractionation

RT without AF

ACTIVE COMPARATOR

Patients without PTV/OAR overlap will receive standard fractionated treatment.

Radiation: Standard of Care (SOC)

Interventions

SBRT with adaptive fractionation RADIATION

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.

RT with AF

Standard of Care (SOC) RADIATION

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.

RT without AF

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Zurich: lead

Study Sites (1)

University Hospital Zurich

Zurich, Canton of Zurich, 8091, Switzerland

RECRUITING

MeSH Terms

Conditions

Abdominal Neoplasms; Pelvic Neoplasms

Interventions

Radiosurgery; Standard of Care

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Reinhardt Krcek, Dr. med.

  University of Zurich

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jan Unkelbach, Prof. Dr. rer. nat.

CONTACT

+41 44 255 85 49; jan.unkelbach@usz.ch

Lena Kretzschmar, Dr. med.

CONTACT

lena.kretzschmar@usz.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 30, 2026
• First Posted: July 7, 2026
• Study Start: June 16, 2026
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: July 7, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)