Stereotactic Ablative Radiotherapy for Comprehensive Treatment of Oligometastatic Tumors (SABR-COMET)

Launched by LONDON HEALTH SCIENCES CENTRE RESEARCH INSTITUTE OR LAWSON RESEARCH INSTITUTE OF ST. JOSEPH'S · Oct 3, 2011

Keywords

ClinConnect Summary

The SABR-COMET trial is studying a new type of radiation treatment called Stereotactic Ablative Radiotherapy (SABR) for patients with metastatic tumors, which are cancer cells that have spread from the original tumor to other parts of the body. This trial aims to see if SABR, which delivers precise and high doses of radiation in just 1-3 weeks, can improve survival and quality of life compared to traditional chemotherapy and older radiation methods. This could be important because more precise treatment may lead to fewer side effects while still effectively controlling the cancer.

To be eligible for this trial, participants should be at least 18 years old and have a confirmed diagnosis of metastatic cancer that can be safely treated with SABR. They should also have a controlled primary tumor and a life expectancy of more than six months. The study is currently active but not recruiting new participants, meaning they are not looking for additional volunteers at this time. If you or a loved one is considering this trial, it may offer a new option for managing metastatic tumors that have not responded to other treatments.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Age 18 or older
• • Willing to provide informed consent
• • Histologically confirmed malignancy with metastatic disease detected on imaging. Biopsy of metastasis is preferred, but not required.
• • ECOG performance status 0-1
• • Controlled primary tumor
• • a. defined as: at least 3 months since original tumor treated definitively, with no progression at primary site
• • All sites of disease can be safely treated based on criteria below
• • Maximum 3 metastases in any single organ system (i.e. lung, liver, brain, bone)
• • Life expectancy \>6 months
• • Not a candidate for surgical resection at all sites: surgery to all sites not recommended by multidisciplinary team, or unfit or declining surgery
• • Prior chemotherapy allowed but no systemic therapy 4 weeks prior to first fraction of radiotherapy, during radiotherapy, or for two weeks after last fraction
• * Patients with metastases that have been previously treated (e.g. prior resection, Radiofrequency Ablation (RFA) or radiotherapy):
• • a. If that previously treated metastasis is controlled on imaging, the patient is eligible for this study and that site does not need treatment
• a. If that previously treated metastasis is NOT controlled on imaging:
• • 1. If the previous treatment was surgery, the patient is eligible if that site can be treated by SABR
• • 2. If the previous treatment was radiotherapy or RFA, the patient is ineligible.
• • Patient presented at multidisciplinary tumor board or quality-assurance rounds.
• Exclusion Criteria:
• • Serious medical comorbidities precluding radiotherapy
• • Bone metastasis in a femoral bone
• • Patients with 1-3 brain metastasis and no disease elsewhere (these patients should not be randomized but treated with stereotactic radiotherapy as per results of randomized trials)
• • Prior radiotherapy to a site requiring treatment
• • Complete response to first-line chemotherapy (i.e. no measurable target for SABR)
• • Malignant pleural effusion
• • Inability to treat all sites of active disease
• • Clinical or radiologic evidence of spinal cord compression OR tumor within 3 mm of spinal cord on Magnetic Resonance Imaging (MRI).
• • Dominant brain metastasis requiring surgical decompression
• • Pregnant or lactating women