A Randomised, Prospective, Monoinstitutional Study of Ablative Radiosurgery vs Stereotactic Radiotherapy in 5 Fractions, With Simultaneous Integrated Boost, for the Treatment of Bone Lesions in Oligometastatic Disease
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- IRCCS San Raffaele
- Enrollment
- 307
- Locations
- 1
- Primary Endpoint
- Local recurrence-free surival
Study Overview
Brief Summary
This is a randomised prospective monoinstitutional study comparing radiosurgery at a total dose up to 24 Gy to five fraction stereotactic radiotherapy with simultaneous integrated boost (SIB) up to 50 Gy for the treatment of bone metastases in oligometastatic cancer treated with radical intent. At the end of the first 12 months from the start of the study an interim analysis will be performed taking into account all major endpoints for an initial evaluation of the study , with only an observational purpose, without subsequent protocol changes.
Detailed Description
The study is interventional, homogeneous (performed in a single institution). Patient recruitment Patients who meet the inclusion criteria will be enrolled during the initial Radiation Oncology examination in our institution or during the multidisciplinary meeting.
Recruitment and selection The patients will be informed of the possibility to participate in the study. I pazienti verranno informati ella possibilità di accedere allo studio. After a careful verification of the inclusion and exclusion criteria, and precise description of the benefits, risks and procedure of the current study, the patient will be asked to sign the informed consent and subsequently randomised.
The following information will be collected for each patient, as is standard practice in our department: demographic data, clinical history, concomitant medical treatments, physical exam, blood exam, tumoral markers, diagnoses CT / Bone scintigraphy/ MRI/ PET and any other staging exam or post tumoral treatment re-evaluation performed.
Randomisation A centralized randomization, with closed envelopes, will be performed by a secretary not involved in the study.
Pre-treatment phase Each patient will undergo the simulation CT, in line with routine clinical practice, with immobilisation devices within 15 (+/- 5) days from the randomisation. The simulation CT will be performed in the Radiotherapy department, the MRI in the Radiology department.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 85 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Performance status ECOG ≤2
- •Life expectancy > 6 months according to Mizumoto criteria*
- •Oligometastatic disease (Total number of metastases from 1 to 5: both synchronous and metachronous with maximum involvement of three organs in total - lymph nodes, bones, lungs, liver, adrenal gland, brain- with known histology
- •At least one bone metastasis treatable with SABR or SRS
- •Each secondary localization (synchronous, metachronous or oligoprogressive) must be treated with radical intent.
- •Patients may have received other anticancer treatments (surgery for initial site of disease or other metastases, chemotherapy, radiotherapy for other metastatic sites)
Exclusion Criteria
- •Sites of disease not eligible for stereotactic radiotherapy
- •Serious medical comorbidities that preclude RT
- •Overlap with a previously treated volume of radiotherapy
- •Dimension greater than 5 cm for extra-cranial lesions.
- •Size greater than 3 cm for brain lesions
- •More than 1 brain metastases
- •Clinical or radiological evidence of spinal cord compression or epidural tumor within 2mm of the spinal cord
- •Radiological evidence of vertebral body fracture or involvement of more than 40% of the vertebral body
- •Radiological evidence of cortical involvement in long bones
- •Pregnant or breastfeeding women
Arms & Interventions
Arm A
Single fraction radiosurgery on bone metastases (21-24Gy x 1 fraction)
Intervention: radiosurgery and stereotactic ablative radiotherapy with simultaneous integrated boost, respectively (Radiation)
Arm B
Multi-fractioned stereotactic ablative radiotherapy (5 fractions delivered in 5 consecutive working days) with SIB on bone metastases (5Gy x 5 fractions + SIB up to 40-50Gy)
Intervention: radiosurgery and stereotactic ablative radiotherapy with simultaneous integrated boost, respectively (Radiation)
Outcomes
Primary Outcomes
Local recurrence-free surival
Time Frame: 3 years from the end of treatment
evaluation of the impact of stereotactic radiotherapy (one fraction versus fractionated) on local control of disease in terms of local recurrence free survival (LRFS) in patients with oligometastastic disease and at least one bone metastasis.
Secondary Outcomes
- Pain control(Changes form baseline at 3 years from the end of treatment)
- Adjusted disease-free survival(3 years from the end of treatment)
- Satisfaction assessed by EQ-5D-3L(Changes from baseline at 3 years after the treatment)
- Overall survival(3 years from the end of treatment)
- Acute and late local toxicity(Changes form baseline at 3 years from the end of treatment)
- Incidence of Treatment-Emergent Adverse Events as assessed by EORTC-QLQ-BM22(Changes from baseline at 3 years after the treatment)
- Cancer Specific Survival(3 years from the end of treatment)
- Progression to polymetastatic disease(3 years from the end of treatment)
- Incidence of Treatment-Emergent Adverse Events as assessed by EORTC-QLQ-C30(Changes from baseline at 3 years after the treatment)
Investigators
Nadia Di Muzio
Professor
IRCCS San Raffaele