Stereotactic Ablative Radiotherapy for Comprehensive Treatment of Oligometastatic Tumors (SABR-COMET): A Randomized Phase II Trial
- Conditions
- cancer spread to other parts of the body10027476metastatic cancer
- Registration Number
- NL-OMON37922
- Lead Sponsor
- Vrije Universiteit Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 20
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, 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 chemotherapy (cytotoxic or molecularly targeted agents) therapy 4 weeks prior to first fraction of radiotherapy, during radiotherapy, or for two weeks after last fraction. Hormonal therapy is allowed.
Patients with metastases that have been previously treated (e.g. prior resection, RFA or radiotherapy):
*If that previously treated metastasis is controlled on imaging, the patient is eligible for this study and that site does not need treatment
*If that previously treated metastasis is NOT controlled on imaging:
* If the previous treatment was surgery, the patient is eligible if
that site can be treated by SABR
* If the previous treatment was radiotherapy or RFA, the patient is ineligable;Patient presented at multidisciplinary tumor board or quality-assurance rounds.
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 MRI.
Dominant brain metastasis requiring surgical decompression
Pregnant or lactating women
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>* Overall Survival, defined as time from randomization to death from any cause.</p><br>
- Secondary Outcome Measures
Name Time Method <p>* Quality of life, assessed with the Functional Assessment of Cancer<br /><br>Therapy: General (FACT-G).<br /><br>* Toxicity, assessed by the National Cancer Institute Common Toxicity Criteria<br /><br>(NCI- CTC) version 4 for each organ treated .<br /><br>* Progression-free survival: time from randomization to disease progression at<br /><br>any site or death.<br /><br>* Lesional control rate.<br /><br>* Number of cycles of further chemotherapy/systemic therapy.</p><br>