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

Primary Purpose

Oligometastatic Disease, Bone Metastases, Stereotactic Body Radiotherapy

Status

Active

Phase

Not Applicable

Locations

International

Study Type

Interventional

Intervention

SABR

About this trial

This is an interventional treatment trial for Oligometastatic Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.
All metastatic sites are treated or planned for ablative therapy (including surgery) - for OPD only the sites in progression is required to fulfil this criterion. • A baseline scan within 28 days of inclusion (CT or PET- CT).
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.

Exclusion Criteria:

Patient cannot tolerate physical set up required for SABR.
Uncontrolled intercurrent illness.
Pregnancy.
Bilsky score ≥ 1b. If the patient is treated with surgery, a pre-operative Bilsky score ≥ 1b is an exclusion criterion as well. See appendix A for Bilsky score.
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. -

Sites / Locations

Aalborg Universitetshospital
Herlev Hospital
Rigshospitalet
Odense University Hospital
St Olavs Universitetssykehus,
Ålesund sjukehus

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Single arm

Arm Description

All recruited patients are treated with SABR.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Symptomatic Skeletal Event (SSE) of the irradiated site is defined as a radiographically verification of fracture (vertebral or non-vertebral, pathological or non-pathological), within or adjacent to the PTV of the irradiated site. The fracture must co-exist with one of the

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

Response categories is based on patient reported pain scores (NPRS). The 11- 9 Protocol version 1.1, 01052020. Stereotactic ablative radiotherapy (SABR) of bony metastases in patients with oligometastatic disease - A phase II study point NPRS ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable").

NCI CTCAE ≥ grade 3 toxicity

Cummulated fraction of patients, who encounter one or more ≥ grade 3 NCI CTCAE toxicity within the first 3-months after SBRT.

NCI CTCAE ≥ grade 3 late toxicity

Cummulated fraction of patients, who encounter one or more ≥ grade 3 NCI CTCAE toxicity from 3-months and onward after SBRT including patients who have unresolved early toxicity (encontered within the first 3-months), that is not resolved at the 24-weeks follow-up.

Local progression free survival

Local progression free survival is defined as time from inclusion until progression of the irradiated lesion. Patients are not censored from analysis in case of new lesions outside the irradiated volume. The irradiated volume is defined as, within or adjacent to the PTV. Local progression free survival is reported as a continuos variable.

Progression-free survival (PFS)

Progression-free survival is defined as time from inclusion until disease progression or death following symptoms/interventions: progression in pain (according to definition in section 3.5), development of neurological symptoms/ symptomatic spinal cord compression or a need for surgical intervention/ reirradiation. It should be concluded from the treating physician that the symptom/intervention is a result of the fracture. Vertebral fractures include end plate-only fractures. Analysis is done at a lesion level, lesion by lesion. Patients with a pathological fracture before the radiation therapy, will not be included for analysis

Time to progression (TTP) outside the radiation field

Time to progression outside the radiation field is defined, as the time from inclusion until progression outside the radiation field, determined by a CT -, MR -, or PET-CT - scan. Outside the radiation field is defined as outside and not adjacent to the PTV.

Overall survival (OS)

OS is defined as time from inclusion until death from any cause

Quality of life (QoL) measured with EQ-5D-5L.

Change from baseline in mobility using the 5-level system in EQ-5D-5L

Quality of life (QoL) measured with EQ-5D-5L.

Change from baseline in self-care score using the 5-level system in EQ-5D-5L

Quality of life (QoL) measured with EQ-5D-5L.

Change from baseline in usual activities score using the 5-level system in EQ-5D-5L.

Quality of life (QoL) measured with EQ-5D-5L.

Change from baseline in pain/discomfort score using the 5-level system in EQ-5D-5L.

Quality of life (QoL) measured with EQ-5D-5L.

Change from baseline in anxiety/depression score using the 5-level system in EQ-5D-5L.

Quality of life (QoL) measured with EQ-5D-5L.

Change from baseline in self assessed EQ visual analogue scale in EQ-5D-5L

Full Information

NCT ID

NCT05101824

First Posted

March 25, 2021

Last Updated

July 10, 2023

Sponsor

Gitte Fredberg Persson MD PhD

1. Study Identification

Unique Protocol Identification Number

NCT05101824

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

November 1, 2019 (Actual)

Primary Completion Date

January 13, 2023 (Actual)

Study Completion Date

November 1, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Gitte Fredberg Persson MD PhD

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

Detailed Description

Patients with a histology or cytology proven non-hematological cancer and at least one lesion in the bones are eligible. Patients with de novo- and induced oligometastatic disease, as well as patients with oligo-recurrence or oligo-progression disease can be included. A total of 67 patients will be enrolled. The overall aim is to document long time follow-up in respect to local control rate, OS, PFS, rate of symptomatic skeletal event at the irradiated site(s), time to progression outside the radiation field at 1-, 2- and 5-years and acute/ late toxicities. The primary endpoint is the rate of local control 1-year post SABR. Patients will have a CT scan and a clinical evaluation every 3 month after SABR according to the standard clinical follow-up program. During the 1 year follow-up we also perform pain assessment (using the Numeric Pain Rating Scale), report the analgesic consumption and Quality of life (QoL) measured with EQ-5D-5L. Two dose levels are offered with either 37.5 gy in 3 fractions or 30 gy in 3 fractions, prescribed to the GTV.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Oligometastatic Disease, Bone Metastases, Stereotactic Body Radiotherapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

Single arm, multicenter, phase 2 study

Masking

None (Open Label)

Allocation

N/A

Enrollment

67 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Single arm

Arm Type

Other

Arm Description

All recruited patients are treated with SABR.

Intervention Type

Radiation

Intervention Name(s)

SABR

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Description

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

Time Frame

1-year post SABR

Secondary Outcome Measure Information:

Title

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

Description

Time Frame

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

Title

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

Description

Time Frame

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

Title

NCI CTCAE ≥ grade 3 toxicity

Description

Cummulated fraction of patients, who encounter one or more ≥ grade 3 NCI CTCAE toxicity within the first 3-months after SBRT.

Time Frame

Measured at 2-, 12-weeks post SBRT

Title

NCI CTCAE ≥ grade 3 late toxicity

Description

Time Frame

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

Title

Local progression free survival

Description

Time Frame

continuous within 2-years post SBRT

Title

Progression-free survival (PFS)

Description

Time Frame

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

Title

Time to progression (TTP) outside the radiation field

Description

Time Frame

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

Title

Overall survival (OS)

Description

OS is defined as time from inclusion until death from any cause

Time Frame

continuous till 2-year post SABR

Title

Quality of life (QoL) measured with EQ-5D-5L.

Description

Change from baseline in mobility using the 5-level system in EQ-5D-5L

Time Frame

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

Title

Quality of life (QoL) measured with EQ-5D-5L.

Description

Change from baseline in self-care score using the 5-level system in EQ-5D-5L

Time Frame

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

Title

Quality of life (QoL) measured with EQ-5D-5L.

Description

Change from baseline in usual activities score using the 5-level system in EQ-5D-5L.

Time Frame

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

Title

Quality of life (QoL) measured with EQ-5D-5L.

Description

Change from baseline in pain/discomfort score using the 5-level system in EQ-5D-5L.

Time Frame

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

Title

Quality of life (QoL) measured with EQ-5D-5L.

Description

Change from baseline in anxiety/depression score using the 5-level system in EQ-5D-5L.

Time Frame

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

Title

Quality of life (QoL) measured with EQ-5D-5L.

Description

Change from baseline in self assessed EQ visual analogue scale in EQ-5D-5L

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. All metastatic sites are treated or planned for ablative therapy (including surgery) - for OPD only the sites in progression is required to fulfil this criterion. • A baseline scan within 28 days of inclusion (CT or PET- CT). 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. Exclusion Criteria: Patient cannot tolerate physical set up required for SABR. Uncontrolled intercurrent illness. Pregnancy. Bilsky score ≥ 1b. If the patient is treated with surgery, a pre-operative Bilsky score ≥ 1b is an exclusion criterion as well. See appendix A for Bilsky score. 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. -

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Gitte Persson

Organizational Affiliation

Hospital of Herlev and Gentifte

Official's Role

Principal Investigator

Facility Information:

Facility Name

Aalborg Universitetshospital

City

Aalborg

Country

Denmark

Facility Name

Herlev Hospital

City

Herlev

ZIP/Postal Code

2730

Country

Denmark

Facility Name

Rigshospitalet

City

København

ZIP/Postal Code

2100

Country

Denmark

Facility Name

Odense University Hospital

City

Odense

ZIP/Postal Code

5000

Country

Denmark

Facility Name

St Olavs Universitetssykehus,

City

Trondheim

Country

Norway

Facility Name

Ålesund sjukehus

City

Ålesund

ZIP/Postal Code

6026

Country

Norway

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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