Actively Recruiting
Stereotactic Ablative Radiotherapy (SABR) for the Treatment of Patients With Metastatic Cancer, ID-COMET Trial
Led by Roswell Park Cancer Institute · Updated on 2026-02-04
800
Participants Needed
1
Research Sites
417 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This protocol is comprised of three unblinded, randomized, single-center studies to evaluate the impact of immediate versus three-month delayed comprehensive ablative treatment on survival in newly diagnosed metastatic patients with lung (Trial 1), colorectal (Trial 2), and prostate (Trial 3) cancers
CONDITIONS
Official Title
Stereotactic Ablative Radiotherapy (SABR) for the Treatment of Patients With Metastatic Cancer, ID-COMET Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 1 year or older.
- Willing to provide informed consent.
- ECOG performance status 3 or less.
- Life expectancy greater than 6 months.
- Histologically confirmed lung, prostate, or colorectal cancer with metastatic disease detected on imaging for Trials 1-3. Biopsy of metastasis preferred but not required.
- Any malignancy with metastasis for Trial 4; liquid tumors eligible if biopsy confirmed refractory disease and eligible for salvage radiotherapy.
- Newly diagnosed metastatic disease with 1-10 sites for Trials 1-3. Previously diagnosed metastatic disease with 1-10 sites or oligoprogression in 5 or fewer sites for Trial 4.
- Restaging completed within 12 (+/- 4) weeks prior to randomization.
- No CT changes suggesting fibrotic interstitial lung disease for patients receiving thoracic radiotherapy, or assessed by respirologist if changes are present.
- Participants of child-bearing potential agree to use adequate contraceptive methods before study entry.
- Participant or legal representative must understand the investigational nature and sign approved informed consent before any study procedure.
You will not qualify if you...
- No option for standard systemic therapy or refusal of systemic therapy.
- Received chemotherapy or radiotherapy within 3 weeks (6 weeks for nitrosoureas or mitomycin C) before study entry or not recovered from previous treatment adverse events.
- Serious medical conditions preventing radiotherapy, including interstitial lung disease (for thoracic radiation), Crohn's disease (if GI tract will receive radiotherapy), ulcerative colitis (if bowel will receive radiotherapy), lupus, or scleroderma.
- Moderate or severe liver dysfunction (Child Pugh B or C) for patients with liver metastases.
- Substantial overlap with previously treated radiation volume beyond dose constraints.
- Malignant pleural effusion.
- Inability to treat all sites of disease.
- Metastatic disease invading GI tract or skin.
- Known brain metastases.
- Uncontrolled illness including active infection, symptomatic heart failure, unstable angina, arrhythmia, or psychiatric/social conditions limiting study compliance.
- Pregnant or nursing female participants.
AI-Screening
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Trial Site Locations
Total: 1 location
1
Roswell Park Comprehensive Cancer Center
Buffalo, New York, United States, 14263
Actively Recruiting
Research Team
A
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How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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