Stereotactic Ablative Body Radiotherapy (SABR) for Oligometastases

Launched by BRITISH COLUMBIA CANCER AGENCY · Oct 12, 2016

Keywords

ClinConnect Summary

This clinical trial is studying a type of treatment called Stereotactic Ablative Body Radiotherapy (SABR) for patients with oligometastatic disease, which means they have a limited number of metastatic tumors that have spread from the original cancer site. The main goals of the study are to see how safe this treatment is and to observe any benefits in terms of how long patients survive after receiving SABR. The trial is currently active but not recruiting new participants.

To be eligible for the trial, participants must be able to provide consent and have a confirmed cancer diagnosis with up to five metastases that haven't been fully treated. They must also have had their primary tumor treated and be deemed unfit for surgery. Certain health checks, such as imaging tests and blood tests, are required before starting the treatment. Participants will be asked to complete quality of life questionnaires throughout the study. It’s important to note that some patients, like those with specific brain metastases or serious health conditions, may not qualify for this trial. Overall, this study aims to gather important information about SABR's effectiveness and safety for managing metastatic tumors.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Able to provide informed consent
• • Histologically confirmed malignancy with metastatic disease detected on imaging.
• • Biopsy of metastasis is preferred, but not required.
• • Primary tumour treated radically or controlled by prior palliative radiotherapy or systemic therapy
• • Maximum 5 metastases eligible for SABR (either 5 in total or 5 not controlled by prior treatment)
• * Standard of care tests prior to SABR CT simulation within 14 weeks:
• • Brain CT or MRI imaging (for tumour sites with propensity for brain metastasis)
• * Body imaging:
• • CT chest/abdomen/pelvis, with or without bone scan (at discretion of study doctor), required if no PET-CT is performed
• * PET-CT or PSMA-PET is only required for specific evidence-based indications, and in such cases the CT neck/chest/abdomen/pelvis and bone scan are not required:
• • MRI spine for patients with vertebral or paraspinal metastases
• • For other indications, at the discretion of the treating oncologists, e.g. PET-CT scans may be done but are not required.
• • Blood tests as per standard of care
• • Pregnancy test for women of child-bearing age
• • ECOG performance status 0-2
• • All sites of progressive disease can be safely treated based on criteria below
• • For non-brainstem mets, maximum size of 3cm if using single fraction radiosurgery.
• • If size is from 3.1 to 4cm, 25-35Gy/5 can be considered
• • All brain metastases cases need approval from Stereotactic Radiosurgery (SRS) rounds
• * Maximum size of 6 cm for lesions outside the brain, except:
• • Bone metastases over 6 cm may be included, if in the opinion of the local PI it can be treated safely (e.g. rib, scapula, pelvis)
• • Life expectancy \> 6 months
• • In many scenarios, this is best estimated by a multidisciplinary opinion from disease site experts, often obtained by presentation at multidisciplinary tumours rounds.
• • Not a candidate for surgical resection at all sites: surgery to all sites not recommended by multidisciplinary team, or unfit or declining surgery.
• • No chemotherapy agents (cytotoxic, or molecularly targeted agents) will be used within the period of time commencing 2 weeks prior to radiation, lasting until 1 week after the last fraction. Certain chemotherapy agents may require a longer break prior to or after SABR if protocols dictate. Hormonal therapy during SABR is allowed.
• * Patients with metastases that have been previously treated may be eligible for this SABR protocol:
• • If the previous treatment was systemic therapy, the patient may be eligible, if the metastases have demonstrated a complete radiologic response
• • If the previous treatment was by a local non-radiation means (e.g. prior resection, RFA or microwave ablation), then SABR may be considered for residual/recurrent disease
• • If the previous treatment was SABR, the patient is not eligible unless the new site(s) was/were not previously treated
• • If the previous treatment was conventional RT, SABR could be considered if it can be delivered safely. In such a circumstance it must be presented in a multidisciplinary setting for approval.
• • Review and consensus by 3 disease site experts, or tumour group conference, for eligibility/prognosis Patients must be able and willing to complete quality of life questionnaires in English, and other assessments that are a part of this study, via paper or online using REDCap (if email address is provided by participant on the informed consent) Note: The potential treating SABR radiation oncologist reserves the right to require a multidisciplinary note documenting life expectancy, other treatment options and suitability for SABR.
• Exclusion Criteria:
• • Serious medical co-morbidities precluding radiotherapy
• • Bone metastasis in a femoral bone if risk of pending fracture is high
• • Participants with 1-3 brain metastasis and no disease elsewhere (these participants should not be accrued but treated with stereotactic radiotherapy as per results of published randomized trials)
• • Complete response to first-line chemotherapy (i.e. no measurable target for SABR)
• • Persistent malignant pleural effusion
• • Inability to treat all sites of active disease with ablative intent
• • Clinical or radiological evidence of spinal cord compression
• • Dominant brain metastasis requiring surgical decompression
• • a candidate for a clinical trial that randomizes between SABR and a standard treatment
• • Pregnant or lactating women