A Randomized Phase III Trial of Stereotactic Ablative Radiotherapy for the Comprehensive Treatment of 4-10 Oligometastatic Tumors (SABR-COMET 10)
- Conditions
- metastasesoligometastases10027476
- Registration Number
- NL-OMON52850
- Lead Sponsor
- ondon Health Sciences Center- Lawson Health Research Institute
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 20
• Age 18 or older
• Willing to provide informed consent
• Karnofsky performance score >60
• Life expectancy >6 months
• Histologically confirmed malignancy with metastatic disease detected on
imaging. Biopsy of metastasis is preferred, but not required.
• Restaging within 12 weeks prior to randomization:
o Brain: CT or MRI for tumor sites with propensity for brain metastasis. All
patients with brain metastases (at enrollment or previously treated) require an
MRI.
o Body: 18-FDG PET/CT imaging is recommended, except for tumors where FDG
uptake is not expected (e.g. prostate, renal cell carcinoma). PSMA-PET or
choline-PET is recommended for prostate cancer. In situations where a PET scan
is unavailable, or for tumors that do not take up radiotracer, CT
neck/chest/abdomen/pelvis with bone scan required.
o Spine: MRI required for patients with vertebral or paraspinal metastases. The
MRI needs to image the area being treated and one vertebrae above and below as
a minimum, but does not need to be a whole spine MRI unless clinically
indicated.
•
• Controlled primary tumor
o defined as: at least 3 months since original tumor treated definitively, with
no progression at primary site
• Total number of metastases 4-10
• All sites of disease can be safely treated based on a pre-plan
• Serious medical comorbidities precluding radiotherapy. These include
interstitial lung disease in patients requiring thoracic radiation, Crohn*s
disease in patients where the GI tract will receive radiotherapy, or ulcerative
colitis where the bowel will receive radiotherapy and connective tissue
disorders such as lupus or scleroderma.
• For patients with liver metastases, moderate/severe liver dysfunction (Child
Pugh B or C)
• Substantial overlap with a previously treated radiation volume. Prior
radiotherapy in general is allowed, as long as the composite plan meets dose
constraints herein. For patients treated with radiation previously, biological
effective dose calculations should be used to equate previous doses to the
tolerance doses listed in Appendix 1. All such cases must be discussed with one
of the study PIs.
• Malignant pleural effusion
• Inability to treat all sites of disease
• Any single metastasis >5 cm in size. Bone metastases larger than 5 cm may be
included if, in the opinion of one of the study PIs, it can be treated safely.
• Any brain metastasis >3 cm in size or a total volume of brain metastases
greater than 30 cc.
• Metastasis in the brainstem
• Clinical or radiologic evidence of spinal cord compression
• Dominant brain metastasis requiring surgical decompression
• Metastatic disease that invades any of the following: GI tract (including
esophagus, stomach, small or large bowel), mesenteric lymph nodes, or skin
• Pregnant or lactating women
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Primary Endpoint<br /><br>• Overall Survival<br /><br>o Defined as time from randomization to death from any cause</p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary endpoints:<br /><br>• Progression-free survival<br /><br>o Time from randomization to disease progression at any site or death<br /><br>• Time to development of new metastatic lesions<br /><br>• Quality of life<br /><br>o Assessed with the Functional Assessment of Cancer Therapy: General (FACT-G)<br /><br>and the EQ-5D-5L<br /><br>• Toxicity<br /><br>o Assessed by the National Cancer Institute Common Toxicity Criteria (NCI-CTC)<br /><br>version 4 for each organ treated (e.g. liver, lung, bone)]<br /><br><br /><br>Translational endpoints (see section 12)<br /><br>• Assessment of circulating tumor cells, cell-free DNA, and tumor DNA as<br /><br>prognostic and predictive markers of survival, and for early detection of<br /><br>progression<br /><br>• Assessment of immunological predictors of response and long-term survival</p><br>