Recruiting
Phase 2

SBRT vs. Palliative Radiation

Sponsor:

Roswell Park Cancer Institute

Code:

NCT04068649

Conditions

Metastatic Malignant Neoplasm

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Palliative Radiation Therapy

Quality-of-Life Assessment

Questionnaire Administration

Stereotactic Body Radiation Therapy

Study Details

Brief summary:

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.

Conditions

Metastatic Malignant Neoplasm

Study ID

NCT04068649

Start date

Nov 18, 2019

Status verified date

Apr, 2026

Completion date

Nov 18, 2027

Anticipated

Primary completion date

Nov 18, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion 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

Exclusion Criteria:

  • 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

Study Design

Enrollment

1500 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Arm I (palliative RT)

Patients undergo 1, 3-5, 5-6, or 10 fractions of palliative RT deemed appropriate by the treating physician.

experimental: Arm II (SBRT)

Patients undergo single fraction SBRT.

Interventions

Palliative Radiation Therapy

Undergo palliative RT

Quality-of-Life Assessment

Ancillary studies

Questionnaire Administration

Ancillary studies

Stereotactic Body Radiation Therapy

Undergo SBRT

Primary outcome measure

  • Pain responses [ Time Frame: Baseline up to 12 weeks ]
  • Change in Quality of life [ Time Frame: Baseline up to 12 weeks ]

Central Contacts and Locations

Locations

Roswell Park Cancer Institute

Recruiting

Buffalo, New York, United States, 14263

Contacts

Anurag K. Singh

716-845-3218Anurag.Singh@roswellpark.org

Principal Investigator:

Anurag K. Singh

The Cancer Institute at St. Francis Hospital

Recruiting

East Hills, New York, United States, 11548

Contacts

Anne Vinokur, MD

516-222-2020anne.vinokur@chsli.org

Good Samaritan Hospital

Recruiting

West Islip, New York, United States, 11795

Contacts

Johnny Kao, MD

631-376-4047Johnny.kao@chsli.org

More Information

Sponsor

Roswell Park Cancer Institute

Last update posted

Apr 30, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Roswell Park Cancer Institute on 2026-04-30.