Stereotactic Ablative Radiotherapy (SABR) for the Treatment of Patients With Metastatic Cancer, ID-COMET Trial

NCT06563388 | Recruiting Phase 3 DMC

• 1 other identifier: I-3739023
• Study Type: interventional
• Target: 800
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Oligometastasis; Lung Cancer; Colo-rectal Cancer; Prostate Cancer

Outcome Measures

Primary Outcomes (2)

• Overall Survival - Trial 1 and 2

  Calculated from the time of randomization until death

  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.

  Up to 5 years

Secondary Outcomes (2)

• Change in Quality of Life

  Up to 5 years after radiation treatment

• Physician determined Radiation related toxicity

  5 years

Study Arms (3)

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

Interventions

Stereotactic Ablative Radiotherapy PROCEDURE

Radiation therapy begins after 3 months of Standard of care

Also known as: SABER, SABR/SBRT

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 Practice OTHER

Receive standard of care therapy

Also known as: Standard of Care

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

Eligibility Criteria

• Age: 1 Year+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify 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 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.

You may not qualify 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 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.

Sponsors & Collaborators

• Roswell Park Cancer Institute: lead

Study Sites (1)

Roswell Park Comprehensive Cancer Center

Buffalo, New York, 14263, United States

RECRUITING

MeSH Terms

Conditions

Lung Neoplasms; Colonic Neoplasms; Prostatic Neoplasms

Interventions

Practice Guidelines as Topic; Standard of Care

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Guidelines as Topic; Quality Assurance, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Quality Indicators, Health Care

Study Officials

• Anurag Singh, MD

  Roswell Park Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

ASK RPCI

CONTACT

1-800-767-9355; askroswellpark@roswellpark.org

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 18, 2024
• First Posted: August 20, 2024
• Study Start: September 18, 2024
• Primary Completion (Estimated): September 18, 2032
• Study Completion (Estimated): September 18, 2032
• Last Updated: February 4, 2026

Record last verified: 2026-02

Locations

US (1)