RECRUITING

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

Conditions

Oligometastasis Lung Cancer Colo-rectal Cancer Prostate Cancer

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

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

Quick Facts

Study Start:2024-09-18

Study Completion:2032-09-18

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06563388

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:1 Year

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD, ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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 patients for Trials 1-3. Previously diagnosed metastatic patients 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. * Participant 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.	* . 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.

Inclusion Criteria

Exclusion 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 patients for Trials 1-3. Previously diagnosed metastatic patients 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.
* Participant 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.

* . 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.

Contacts and Locations

Study Contact

ASK RPCI

CONTACT

1-800-767-9355

askroswellpark@roswellpark.org

Principal Investigator

Anurag Singh, MD

PRINCIPAL_INVESTIGATOR

Roswell Park Comprehensive Cancer Center

Study Locations (Sites)

Roswell Park Comprehensive Cancer Center

Buffalo, New York, 14263

United States

Collaborators and Investigators

Sponsor: Roswell Park Cancer Institute

Anurag Singh, MD, PRINCIPAL_INVESTIGATOR, Roswell Park Comprehensive Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-09-18

Study Completion Date2032-09-18

Study Record Updates

Study Start Date2024-09-18

Study Completion Date2032-09-18

Terms related to this study

Additional Relevant MeSH Terms

Oligometastasis
Lung Cancer
Colo-rectal Cancer
Prostate Cancer