Stereotactic Ablative Radiotherapy (SABR) for Metastatic Lung, Colorectal, and Prostate Cancers
This study, called ID-COMET, is looking at how Stereotactic Ablative Radiotherapy (SABR) affects people with metastatic cancer. SABR is a type of radiation therapy that delivers high doses of radiation to a tumor. The study is comparing starting SABR right away versus waiting three months after standard care for newly diagnosed metastatic lung, colorectal, and prostate cancers. Researchers want to see if SABR can help people live longer. You might be able to join if you are at least 1 year old, have a life expectancy over 6 months, and have metastatic lung, colorectal, or prostate cancer. The study aims to enroll 800 participants, but its current status is unclear.
- Study design
- This is an unblinded, randomized study conducted at a single center, comparing immediate SABR to delayed SABR. It plans to enroll 800 participants.
- What's involved
- Participants will receive either Stereotactic Ablative Radiotherapy (SABR) immediately or after three months of standard of care therapy.
- Compensation
- Not stated in the trial record.
- Follow-up
- Overall survival will be measured for up to 5 years. Androgen Deprivation Therapy (ADT)-free survival will also be measured for up to 5 years in Trial 3.
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NCT06563388
Stereotactic Ablative Radiotherapy (SABR) for the Treatment of Patients With Metastatic Cancer, ID-COMET Trial
Recruiting
PHASE3Ages 1+InterventionalTreatmentRoswell Park Cancer InstituteInvestigator-initiated
~800 participants
Updated 2026-02-04 on ClinicalTrials.gov
What's tested:Stereotactic Ablative RadiotherapyBest Practice
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Overall Survival - Trial 1 and 2
Measured over UP to 5 years
+1 more outcome measured
Conditions
Where it's being run
1 sites across 1 statesNew York1
Study leadership
- Anurag Singh, MD · PRINCIPAL_INVESTIGATOR · Roswell Park Comprehensive Cancer Center
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
Age 1 year or older.
Willing to provide informed consent.
ECOG ≤ 3.
Life expectancy \> 6 months.
Trials 1-3: Histologically confirmed lung, prostate or colorectal malignancy with metastatic disease detected on imaging. Biopsy of metastasis is preferred, but not required.
Trial 4: Any malignancy with metastasis. Participants with liquid tumors are eligible provided they have biopsy confirmed refractory disease and are eligible for salvage radiotherapy.
Newly diagnosed metastatic (1-10 sites)patients for Trials 1-3. Previously diagnosed metastatic patients (1-10 sites or oligoprogression in 5 or fewer sites with no limit on total number for Trial 4.
Restaging completed within 12 (+/- 4) weeks prior to randomization.
For patients receiving thoracic radiotherapy, the enrolling physician must confirm there are no computed tomography (CT) changes suggestive of fibrotic interstitial lung disease (ILD) (i.e., reticular changes, traction bronchiectasis, or honeycombing) reported on any prior CT scans. If any are present, the patient must be assessed by a respirologist to rule out ILD prior to enrollment.
Participants of child-bearing potential must agree to use adequate contraceptive methods (e.g., hormonal or barrier method of birth control; abstinence) prior to study entry.
Participant or legal representative must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure.
Exclusion
. Participants who have no option for standard systemic therapy or refuse systemic therapy.
Participants who have had chemotherapy or radiotherapy within 3 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 3 weeks earlier.
Serious medical comorbidities precluding radiotherapy. These include ILD in patients requiring thoracic radiation, Crohn's disease in patients where the gastrointestinal (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); please see the Child-Pugh score calculator.
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 E. All such cases must be discussed with the PI or Co-I .
Malignant pleural effusion.
Inability to treat all sites of disease.
Metastatic disease that invades any of the following: GI tract (including esophagus, stomach, small or large bowel) or skin.
Participants with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.
Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
Pregnant or nursing female participants.
What this trial measures
- Overall Survival - Trial 1 and 2UP to 5 years
Calculated from the time of randomization until death
- Androgen DeprivationTherapy (ADT)-free survival - Trial 3Up to 5 years
The time from radomization until receipt of ADT, death due to any cause, end of study or last follow up.