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Radiation
Stereotactic Ablative Radiotherapy for Metastatic Cancer (ID-COMET Trial)
Phase 3
Recruiting
Led By Anurag Singh, MD
Research Sponsored by Roswell Park Cancer Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
ECOG ≤ 3
Any malignancy with metastasis for Trial 4
Must not have
Malignant pleural effusion
Inability to treat all sites of disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights
No Placebo-Only Group
Pivotal Trial
Summary
This trial involves three separate studies that are not blinded, where patients with newly diagnosed metastatic lung, colorectal, and prostate cancers will receive either immediate or delayed ablative treatment. The purpose of the
Who is the study for?
This trial is for adults with newly diagnosed metastatic lung, colorectal, or prostate cancer. They must be willing to consent, have a life expectancy over 6 months, and an ECOG performance status of ≤3 (still active). Restaging scans should be recent. Those with signs of fibrotic interstitial lung disease need respirologist clearance.
What is being tested?
The ID-COMET trial compares immediate versus delayed Stereotactic Ablative Radiotherapy (SABR) in patients with certain types of metastatic cancers. It's unblinded and randomized at one center to see if timing affects survival rates.
What are the potential side effects?
Potential side effects from SABR may include skin reactions, fatigue, shortness of breath, chest pain, and rarely more serious complications like radiation pneumonitis or damage to nearby organs.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can take care of myself but cannot do heavy physical work.
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My cancer has spread to other parts of my body.
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I am at least 1 year old.
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My cancer in the lung, prostate, or colon has spread and this was confirmed by tests.
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I have recently been diagnosed with metastatic cancer.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have fluid buildup due to cancer in the lining of my lung.
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Not all areas of my cancer can be treated.
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I have no standard treatment options left or I refuse to undergo systemic therapy.
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My liver is not working well due to cancer spread.
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I have serious health issues that prevent me from receiving radiotherapy.
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My cancer has spread to my digestive system or skin.
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I am currently pregnant or breastfeeding.
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I have brain metastases.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Androgen DeprivationTherapy (ADT)-free survival - Trial 3
Overall Survival - Trial 1 and 2
Secondary study objectives
Change in Quality of Life
Physician determined Radiation related toxicity
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
3Treatment groups
Experimental Treatment
Group I: Trial 4 - Immediate SABR plus standard of careExperimental Treatment2 Interventions
Group II: Standard Therapy followed by SABR - Trial 1-3 Arm 1Experimental Treatment2 Interventions
Group III: SABR plus Standard therapy - Trial 1-3 Arm 2Experimental Treatment2 Interventions
Find a Location
Who is running the clinical trial?
Roswell Park Cancer InstituteLead Sponsor
414 Previous Clinical Trials
32,922 Total Patients Enrolled
Anurag Singh, MDPrincipal InvestigatorRoswell Park Comprehensive Cancer Center
2 Previous Clinical Trials
136 Total Patients Enrolled