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New treatment option for Oligometastasis
Official title Stereotactic Ablative Radiotherapy (SABR) for the Treatment of Patients With Metastatic Cancer, ID-COMET Trial
ClinicalTrials.gov ID: NCT06563388
What this study is testing
- What it's testing
- 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
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 1 and older
You may be able to join if
- 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...
You likely can't join if
- . 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...
- Serious medical comorbidities precluding radiotherapy. These include ILD in patients requiring thoracic radiation, Crohn's disease in patients where...
- 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...
- Malignant pleural effusion.
See the full eligibility criteria
- 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...
- 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...
- 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...
- . 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...
- 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...
- 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...
- 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...
- 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...
- Pregnant or nursing female participants.
The study team makes the final eligibility decision.
Where it's taking place
- Buffalo, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 1 year and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Buffalo, New York, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.