OligometastasisPhase 3ID-COMETNCT06563388
Stereotactic Ablative Radiotherapy (SABR) for the Treatment of Patients With Metastatic Cancer, ID-COMET Trial
A Phase 3 study testing Stereotactic Ablative Radiotherapy and Best Practice in people with Oligometastasis and Lung Cancer, run by Roswell Park Cancer Institute at 1 site in United States.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 1 year and older
- Conditions the study is for
- Oligometastasis, Lung Cancer, Colo-rectal Cancer
- What is being tested?
- Stereotactic Ablative Radiotherapy and Best Practice
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 800 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Sep 2024to 18 Sep 2032
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Show all 12Show fewer
- 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.
- Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately.
- 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.
Who cannot join
- . 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.
Show all 11Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Roswell Park Comprehensive Cancer Center
Buffalo, New York, 14263
877-275-7724, Askrpci@roswellpark.org
About this study
Official title: (ID-COMET) A Randomized Phase III Trial of Immediate Versus Six-Month Delayed Comprehensive Treatment of 1-10 Oligometastatic Tumors With or Without Synchronous Primary
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
- Oligometastasis, Lung Cancer, Colo-rectal Cancer, Prostate Cancer
- Being tested
- Stereotactic Ablative Radiotherapy, Best Practice
- Medical subject headings
- Lung Neoplasms, Colonic Neoplasms, Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stereotactic Ablative RadiotherapyProcedure or surgery
Also called SABER, SABR/SBRT
Radiation therapy begins after 3 months of Standard of care
Best PracticeOther
Also called Standard of Care
Receive standard of care therapy
| Study group | Role | What they receive |
|---|---|---|
| Standard Therapy followed by SABR - Trial 1-3 Arm 1 | Experimental | Not described Receives: Procedure: Stereotactic Ablative Radiotherapy; Other: Best Practice |
| SABR plus Standard therapy - Trial 1-3 Arm 2 | Experimental | Not described Receives: Procedure: Stereotactic Ablative Radiotherapy; Other: Best Practice |
| Trial 4 - Immediate SABR plus standard of care | Experimental | Not described Receives: Procedure: Stereotactic Ablative Radiotherapy; Other: Best Practice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival - Trial 1 and 2
Calculated from the time of randomization until death
Measured: UP to 5 years
Androgen DeprivationTherapy (ADT)-free survival - Trial 3
The time from radomization until receipt of ADT, death due to any cause, end of study or last follow up.
Measured: Up to 5 years
Secondary outcomes (2)
Change in Quality of Life
Quality of life will be assessed using The EORTC Core Quality of Life questionnaire (EORTC-QLC30). This questionnaire measures cancer patients' physical, psychological and social functions. This 30 item questionnaire ranges from 1 (not at all ) to 4 (Very much) except for the global health status/quality-of-life scale, which has response options ranging from (1) "very poor" to (7) "excellent"
Measured: Up to 5 years after radiation treatment
Physician determined Radiation related toxicity
To document toxicity in patients using the National Cancer Institute Common Toxicity Criteria (NCI-CTC) version 5 for each organ treated
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2024
- Study start18 Sep 2024
- Primary completion18 Sep 2032 (estimated)
- Study completion18 Sep 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OligometastasisStudies of the same condition, open and under way.
- More trials run by Roswell Park Cancer InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Roswell Park Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anurag Singh, MD, Principal investigator, Roswell Park Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06563388
- Sponsor's protocol ID
- I-3739023
- Acronym
- ID-COMET
- Status last verified
- Feb 2026
- First submitted
- 18 Aug 2024
- Last updated
- 4 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- (ID-COMET) A Randomized Phase III Trial of Immediate Versus Six-Month Delayed Comprehensive Treatment of 1-10 Oligometastatic Tumors With or Without Synchronous Primary
- ClinicalTrials.gov ID
- NCT06563388
- Acronym / sponsor ID
- ID-COMET / I-3739023
- Conditions
- Oligometastasis, Lung Cancer, Colo-rectal Cancer, Prostate Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- Roswell Park Cancer InstituteUniversity, hospital or other
- Study start
- 18 Sep 2024 (actual)
- Primary completion
- 18 Sep 2032 (estimated)
- Study completion
- 18 Sep 2032 (estimated)
- First posted
- 20 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Standard Therapy followed by SABR - Trial 1-3 Arm 1 | Experimental | Procedure: Stereotactic Ablative Radiotherapy, Other: Best Practice |
| SABR plus Standard therapy - Trial 1-3 Arm 2 | Experimental | Procedure: Stereotactic Ablative Radiotherapy, Other: Best Practice |
| Trial 4 - Immediate SABR plus standard of care | Experimental | Procedure: Stereotactic Ablative Radiotherapy, Other: Best Practice |
Who may qualify
- Ages
- 1 year and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (12 listed)
- 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.
Key exclusion criteria (11 listed)
- . 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 .
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stereotactic Ablative RadiotherapyAlso: SABER, SABR/SBRTRadiation therapy begins after 3 months of Standard of care | Procedure or surgery | SABR plus Standard therapy - Trial 1-3 Arm 2, Standard Therapy followed by SABR - Trial 1-3 Arm 1, Trial 4 - Immediate SABR plus standard of care |
| Best PracticeAlso: Standard of CareReceive standard of care therapy | Other | SABR plus Standard therapy - Trial 1-3 Arm 2, Standard Therapy followed by SABR - Trial 1-3 Arm 1, Trial 4 - Immediate SABR plus standard of care |
Primary outcome
Overall Survival - Trial 1 and 2
Time frame: UP to 5 years
Calculated from the time of randomization until death
Androgen DeprivationTherapy (ADT)-free survival - Trial 3
Time frame: Up to 5 years
The time from radomization until receipt of ADT, death due to any cause, end of study or last follow up.
2 secondary outcomes
Change in Quality of Life
Time frame: Up to 5 years after radiation treatment
Physician determined Radiation related toxicity
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2026.
Related trials for Oligometastasis
Active, not recruitingPhase 2/3
Veterans Affairs Seamless Phase II/III Randomized Trial of STAndard Systemic theRapy With or Without PET-directed Local Therapy for Oligometastatic pRosTate Cancer
Prostate Cancer, Oligometastasis
RecruitingObservational study
Ablation of Pulmonary Oligometastasis Combined With System for Advanced Hepatocellular Carcinoma
Advanced Hepatocellular Carcinoma, Lung Cancer
RecruitingPhase 2
Delayed Systemic Therapy Following Destructive Local Treatment of Pulmonary Oligometastases After No Evidence of Disease (NED) in Colorectal Cancer.
Colorectal Neoplasms Malignant
RecruitingPhase 3
Metastasis-directed Therapy for Oligometastases of Breast Cancer
Breast Cancer, Oligometastasis
RecruitingPhase 2
Chemotherapy With or Without Radiation or Surgery in Treating Participants With Oligometastatic Esophageal or Gastric Cancer
Gastric Adenocarcinoma, Oligometastasis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Anurag Singh, MD principal investigator
Roswell Park Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Stereotactic Ablative Radiotherapy and Best Practice in people with Oligometastasis and Lung Cancer, run by Roswell Park Cancer Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact ASK RPCI (1-800-767-9355, askroswellpark@roswellpark.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Survival - Trial 1 and 2 (time frame: UP to 5 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2026.