ClinicalTrials.gg
RecruitingNCT07687147ACTIONUpdated Jul 7, 2026

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

An interventional study of SBRT with adaptive fractionation and Standard of Care (SOC) in Abdominal Tumor and Pelvic Tumor, sponsored by University of Zurich. Recruiting at 1 site in Switzerland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-07.

Sponsored by University of Zurich · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Jun 2026; still recruiting 4 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Abdominal Tumor
  • Pelvic Tumor

Keywords

  • adaptive radiotherapy
  • stereotactic body radiotherapy
  • SBRT
  • MR-guided radiotherapy
03

In context

Abdominal Neoplasms

42 studies on the registry are indexed under Abdominal Neoplasms; 14 are open to participants now.

This study's planned enrollment of 100 is above the median of 78 across 26 interventional studies indexed under Abdominal Neoplasms.

Browse Abdominal Neoplasms studies →

Lead sponsor

University of Zurich is the lead sponsor of 1,049 studies on the registry; 133 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • performance status ≥70
  • Abdominal or pelvic (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

Exclusion Criteria:

  • Previous radiation therapy directly overlapping with planned SBRT (type I re-irradiation)
  • More than one PTV irradiated in the same plan
  • 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
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Karnofsky performance status (KPS)

A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.

Studies often ask for 60 or 70 and above. Your doctor gives the score.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
100 participants (estimated)

Study arms

  • Experimental
    RT with AF

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

    Radiation: SBRT with adaptive fractionation

  • Active comparator
    RT without AF

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

    Radiation: Standard of Care (SOC)

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.

06

What researchers measure

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

    Time frame: from enrollment to end of treatment at 1-2 weeks

Secondary outcomes

  1. Acute treatment toxicities

    Acute treatment toxicities for all included patients measured with Common Terminology Criteria for Adverse Events

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

  2. Interfractional variation in PTV/OAR overlap volume

    interfractional variation in PTV/OAR overlap volume, in cc

    Time frame: during treatment (1-2 weeks)

  3. Interfractional variation in GTV/OAR distance

    interfractional variation in GTV/OAR distance, in mm

    Time frame: during treatment (1-2 weeks)

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

    PTV coverage quantified as the area above the dose-volume-histogram curve measured in cc x Gy

    Time frame: after end of treatment (2 weeks after last fraction)

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Jun 2026 (actual). Primary completion is estimated for Dec 2028, 30 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 30, 2026
First posted
Jul 7, 2026
StartActual
Jun 16, 2026
Primary completionEst.
Dec 2028
CompletionEst.
Dec 2028
Last update
Jul 7, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 7, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07687147
Responsible party
Sponsor
First posted
Jul 7, 2026
Start date
Jun 16, 2026
Primary completion
Dec 2028 (estimated)
Completion
Dec 2028 (estimated)
Last update
Jul 7, 2026

Study contacts

Jan Unkelbach, Prof. Dr. rer. nat.
Contact
jan.unkelbach@usz.ch
+41 44 255 85 49
Lena Kretzschmar, Dr. med.
Contact
lena.kretzschmar@usz.ch
Reinhardt Krcek, Dr. med.
principal investigator · University of Zurich

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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