Bony M - Stereotactic Ablative Radiotherapy (SABR) of Bony Metastases in Patients With Oligometastatic Disease - A Phase II Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Oligometastatic Disease
- Sponsor
- Gitte Fredberg Persson MD PhD
- Enrollment
- 67
- Locations
- 6
- Primary Endpoint
- local control rate (LC) at 1-year post SABR
- Status
- Active, not recruiting
- Last Updated
- 2 years ago
Overview
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.
Investigators
Gitte Fredberg Persson MD PhD
Associate professor
Herlev Hospital
Eligibility Criteria
Inclusion Criteria
- •Histology or cytology proven non-haematological cancer.
- •At least one lesion in the bones is required.
- •ECOG performance status ≤
- •≥ 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).
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 \*
- •For spine disease, involvement of ≥ three contiguous vertebrae.
- •Uncontrolled disease in respect to malignant pleural effusion, ascites, lymphangitic carcinomatosis, pleural carcinomatosis or peritoneal carcinomatosis.
Outcomes
Primary Outcomes
local control rate (LC) at 1-year post SABR
Time Frame: 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 Outcomes
- Pain, change from baseline evaluated by "Numeric Pain Rating Scale (NPRS)"(Measured at 2-, 12-, 24-, 36- and 52-weeks post SBRT)
- Local progression free survival(continuous within 2-years post SBRT)
- NCI CTCAE ≥ grade 3 toxicity(Measured at 2-, 12-weeks post SBRT)
- Rate of Symptomatic Skeletal Event (SSE) at the irradiated site(s)(3-, 6-, 12- and 24-months post SBRT)
- NCI CTCAE ≥ grade 3 late toxicity(Measured at 3-, 6-, 12- and 24-months post SBRT)
- Overall survival (OS)(continuous till 2-year post SABR)
- Quality of life (QoL) measured with EQ-5D-5L.(at 3-, 6-, 12- and 24-months post SBRT)
- Progression-free survival (PFS)(Continuous and at 3-, 6-, 12- and 24-months post SBRT)
- Time to progression (TTP) outside the radiation field(Continuous and at 3-, 6-, 12- and 24-months post SBRT)