RECRUITING

Single-Fraction SBRT Versus Standard Palliative Radiation Therapy in Treating Patients With Metastatic 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 phase II trial studies how well single-fraction stereotactic body radiation therapy (SBRT) works when compared to standard radiation therapy in treating patients with cancer that has spread to other places in the body (metastatic). Stereotactic body radiation therapy uses special equipment to position a patient and deliver radiation to tumors with high precision. This method can kill tumor cells with fewer doses over a shorter period and cause less damage to normal tissue.

Official Title

A Phase 2 Randomized Study With a Non-randomized Cohort : Assessing Single-Fraction SBRT Versus Standard Palliative Radiation in Patients With Metastatic Disease (ASTEROID)

Quick Facts

Study Start:2019-11-18

Study Completion:2027-11-18

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04068649

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:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Pathologically confirmed malignancy * Clinical or pathologic evidence of metastatic disease * A site of malignant disease causing symptoms, or for which symptoms are imminent, in which radiation may be used for relief or prophylaxis * 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 * Participants with synchronous primary malignancies must have either: 1) documented control of their second malignancy or 2) have pathological confirmation of the metastatic lesion/disease site being targeted * Participant must be willing and able to participate in protocol requirements, including pre- and post-treatment survey evaluations and clinical assessments * 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	* Prior radiation therapy targeting the same area for which radiation treatment is being planned (i.e., re-irradiation to a specific site of metastatic disease) * Participants with known brain metastases * Pregnant or nursing female participants * Participants who are unable to accurately or reliably recount their pain medication regimens, including type, amount, or frequency of pain medication usage * Participants who require or are being planned for surgical stabilization or metastasectomy of the planned radiation site * Severe, active co-morbidity defined as follows: * Unstable angina and/or congestive heart failure requiring hospitalization within the last 3 months; * Transmural myocardial infarction within the last 3 months; * Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration; * Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration * Unwilling or unable to follow protocol requirements * Any condition which, in the investigator?s opinion, deems the patient unable to participate in enrollment * Adults unable to consent * Individuals who are not yet adults (infants, children, teenagers) * Pregnant women * Prisoners

Inclusion Criteria

Exclusion Criteria

* Pathologically confirmed malignancy
* Clinical or pathologic evidence of metastatic disease
* A site of malignant disease causing symptoms, or for which symptoms are imminent, in which radiation may be used for relief or prophylaxis
* 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
* Participants with synchronous primary malignancies must have either: 1) documented control of their second malignancy or 2) have pathological confirmation of the metastatic lesion/disease site being targeted
* Participant must be willing and able to participate in protocol requirements, including pre- and post-treatment survey evaluations and clinical assessments
* 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

* Prior radiation therapy targeting the same area for which radiation treatment is being planned (i.e., re-irradiation to a specific site of metastatic disease)
* Participants with known brain metastases
* Pregnant or nursing female participants
* Participants who are unable to accurately or reliably recount their pain medication regimens, including type, amount, or frequency of pain medication usage
* Participants who require or are being planned for surgical stabilization or metastasectomy of the planned radiation site
* Severe, active co-morbidity defined as follows:
* Unstable angina and/or congestive heart failure requiring hospitalization within the last 3 months;
* Transmural myocardial infarction within the last 3 months;
* Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration;
* Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration
* Unwilling or unable to follow protocol requirements
* Any condition which, in the investigator?s opinion, deems the patient unable to participate in enrollment
* Adults unable to consent
* Individuals who are not yet adults (infants, children, teenagers)
* Pregnant women
* Prisoners

Contacts and Locations

Principal Investigator

Anurag K Singh

PRINCIPAL_INVESTIGATOR

Roswell Park Cancer Institute

Study Locations (Sites)

Roswell Park Cancer Institute

Buffalo, New York, 14263

United States

The Cancer Institute at St. Francis Hospital

East Hills, New York, 11548

United States

Good Samaritan Hospital

West Islip, New York, 11795

United States

Collaborators and Investigators

Sponsor: Roswell Park Cancer Institute

Anurag K Singh, PRINCIPAL_INVESTIGATOR, Roswell Park Cancer Institute

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 Date2019-11-18

Study Completion Date2027-11-18

Study Record Updates

Study Start Date2019-11-18

Study Completion Date2027-11-18

Terms related to this study

Additional Relevant MeSH Terms

Metastatic Malignant Neoplasm