Stereotactic Ablative Radiotherapy for metastatic cancer treatment
(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 study tests if starting stereotactic ablative radiotherapy right away helps people with newly diagnosed metastatic lung, colorectal, or prostate cancer live longer compared to waiting three months to start treatment.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 800 (estimated) |
| Ages | 1 Year and up |
| Sex | All |
| Sponsor | Roswell Park Cancer Institute Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Buffalo, New York) |
| Trial ID | NCT06563388 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of stereotactic ablative radiotherapy (SABR) in treating newly diagnosed metastatic patients with lung, colorectal, and prostate cancers. It consists of three unblinded, randomized studies comparing immediate treatment to a three-month delayed treatment approach. The goal is to assess the impact of these treatment timings on patient survival rates. Participants must have histologically confirmed metastatic disease and meet specific eligibility criteria.
Who should consider this trial
Good fit: Ideal candidates include patients aged 1 year or older with newly diagnosed metastatic lung, colorectal, or prostate cancer.
Not a fit: Patients with advanced metastatic disease beyond the specified criteria or those with liquid tumors not meeting the eligibility requirements may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve survival outcomes for patients with metastatic cancer.
How similar studies have performed: Previous studies have shown promising results with stereotactic ablative radiotherapy in similar patient populations, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion 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 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. Exclusion Criteria: * . 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.
Where this trial is running
Buffalo, New York
- Roswell Park Comprehensive Cancer Center — Buffalo, New York, United States (Recruiting)
Study contacts
- Principal investigator: Anurag Singh, MD — Roswell Park Comprehensive Cancer Center
- Study coordinator: Ask Rpci
- Email: askroswellpark@roswellpark.org
- Phone: 1-800-767-9355
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.