Bony M - Stereotactic Ablative Radiotherapy (SABR) of Bony Metastases in Patients With Oligometastatic Disease

NCT05101824 | Active Not Recruiting DMC

• 1 other identifier: H-19039071
• Study Type: interventional
• Target: 67
• Locations: 2 countries
• Sites: 6

Brief Summary

This is a prospective, investigator-initiated, phase II, multicentre-study, investigating the efficacy and toxicity of definitive SABR of osseous oligometastases, when pragmatically introduced into a daily clinical setting.

Conditions

Oligometastatic Disease; Bone Metastases; Stereotactic Body Radiotherapy

Outcome Measures

Primary Outcomes (1)

• local control rate (LC) at 1-year post SABR

  Response evaluation is based on the interpretation of a experienced onco-radiologist and modifications from the MDACC response criteria's.

  1-year post SABR

Secondary Outcomes (14)

• Rate of Symptomatic Skeletal Event (SSE) at the irradiated site(s)

  3-, 6-, 12- and 24-months post SBRT

• Pain, change from baseline evaluated by "Numeric Pain Rating Scale (NPRS)"

  Measured at 2-, 12-, 24-, 36- and 52-weeks post SBRT

• NCI CTCAE ≥ grade 3 toxicity

  Measured at 2-, 12-weeks post SBRT

• NCI CTCAE ≥ grade 3 late toxicity

  Measured at 3-, 6-, 12- and 24-months post SBRT

• Local progression free survival

  continuous within 2-years post SBRT

Study Arms (1)

Single arm

OTHER

All recruited patients are treated with SABR.

Radiation: SABR

Interventions

SABR RADIATION

Two fractionation regimes are available (37.5 Gy in 3 fractions and 30.0 Gy in 3 fractions)

Single arm

Eligibility Criteria

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

You may qualify if:

• Histology or cytology proven non-haematological cancer.
• At least one lesion in the bones is required.
• ECOG performance status ≤ 2.
• ≥ 18 years old.
• Life expectancy \> 6 months.
• GTV diameter ≤ 5 cm.
• In case of de novo OMD and OMD recurrence a maximum of 5 targets (including the primary tumour) in a maximum of 3 organ sites are allowed.
• In case of OPD \* and induced OMD\*2 only 3 metastases (including the primary tumour) are allowed.
• The metastatic lesion(s) must be visible on a CT- or MR- scan and suitable for treatment with SABR.
• For spine/paraspinal targets, an MR scan is mandatory, if epidural growth cannot be precluded on the baseline CT scan.
• No curative intended treatment option available.
• An ablative strategy should be deemed clinically relevant and is at the discretion of the treating physician to decide.
• Ability to understand and the willingness to sign a written informed consent document.

You may not qualify if:

• Patient cannot tolerate physical set up required for SABR.
• Uncontrolled intercurrent illness.
• Pregnancy.
• Presence of myelopathy from the target area.
• Candidate for surgical treatment (determined by the institutions clinical oncologist, neurosurgeon or orthopaedic surgeon).
• For spine/paraspinal lesions where epidural growth cannot be precluded on the baseline CT scan: patients for whom an MR scan is contraindicated.
• Mechanical instability and/or fracture risk \*3.
• For spine disease, involvement of ≥ three contiguous vertebrae.
• Uncontrolled disease in respect to malignant pleural effusion, ascites, lymphangitic carcinomatosis, pleural carcinomatosis or peritoneal carcinomatosis.
• Patients with uncontrolled brain metastases.
• If the patient has received previous radiotherapy, the combined dose at the radiation site must not exceed the dose constraints according to Appendix B. -

Sponsors & Collaborators

• Gitte Fredberg Persson MD PhD: lead

Study Sites (6)

Aalborg Universitetshospital

Aalborg, Denmark

Location

Rigshospitalet

Copenhagen, 2100, Denmark

Location

Herlev Hospital

Herlev, 2730, Denmark

Location

Odense University Hospital

Odense, 5000, Denmark

Location

Ålesund sjukehus

Ålesund, 6026, Norway

Location

St Olavs Universitetssykehus,

Trondheim, Norway

Location

Related Publications (1)

• Spindler NJ, Felter MVO, Hansen O, Nielsen TB, Suppli MH, Josipovic M, Poulsen LO, Rahma-Petersen F, Sand HMB, Abramova TM, Johansen M, Kornerup JS, Alsaker MD, Eefsen RL, Serup-Hansen E, Andersen MB, Geertsen P, Vogelius IR, Behrens CP, Persson GF. Stereotactic Ablative Radiation Therapy of Bone Metastases in an Oligometastatic Setting: One-Year Follow-Up of the BONY-M Phase 2 Trial. Int J Radiat Oncol Biol Phys. 2025 Jul 24:S0360-3016(25)06023-7. doi: 10.1016/j.ijrobp.2025.07.1419. Online ahead of print.

  PMID: 40714134 DERIVED

Study Officials

• Gitte Persson

  Hospital of Herlev and Gentifte

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate professor

Model Details: Single arm, multicenter, phase 2 study

Study Record Dates

• First Submitted: March 25, 2021
• First Posted: November 1, 2021
• Study Start: November 1, 2019
• Primary Completion: January 13, 2023
• Study Completion (Estimated): November 1, 2027
• Last Updated: July 11, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

NO (2); DK (4)