Single-Fraction SBRT Versus Standard Palliative Radiation Therapy in Treating Patients With Metastatic Cancer

NCT04068649 | Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: I 81318NCI-2019-04859
• Study Type: interventional
• Target: 1,500
• Locations: 1 country
• Sites: 3

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

Outcome Measures

Primary Outcomes (2)

• Pain responses

  Will be quantified using the pain scales from the Brief Pain Inventory (BPI). Will be an analysis-of-covariance.

  Baseline up to 12 weeks

• Change in Quality of life

  Will be measured with European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30. Will be an analysis-of-covariance.

  Baseline up to 12 weeks

Secondary Outcomes (1)

• Overall survival

  Up to date of last follow-up or date of death, at the time of study analysis, assessed up to 12 weeks

Other Outcomes (6)

• Changes in immune markers

  Up to 12 weeks

• Hospitalization resulting from radiation treatment

  Up to 12 weeks

• Cognitive function

  Up to 12 weeks

Study Arms (2)

Arm I (palliative RT)

EXPERIMENTAL

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

Radiation: Palliative Radiation Therapy; Other: Quality-of-Life Assessment; Other: Questionnaire Administration

Arm II (SBRT)

EXPERIMENTAL

Patients undergo single fraction SBRT.

Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Radiation: Stereotactic Body Radiation Therapy

Interventions

Palliative Radiation Therapy RADIATION

Undergo palliative RT

Arm I (palliative RT)

Quality-of-Life Assessment OTHER

Ancillary studies

Also known as: Quality of Life Assessment

Arm I (palliative RT); Arm II (SBRT)

Questionnaire Administration OTHER

Ancillary studies

Arm I (palliative RT); Arm II (SBRT)

Stereotactic Body Radiation Therapy RADIATION

Undergo SBRT

Also known as: SABR, SBRT, Stereotactic Ablative Body Radiation Therapy

Arm II (SBRT)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Roswell Park Cancer Institute: lead

Study Sites (3)

Roswell Park Cancer Institute

Buffalo, New York, 14263, United States

RECRUITING

The Cancer Institute at St. Francis Hospital

East Hills, New York, 11548, United States

RECRUITING

Good Samaritan Hospital

West Islip, New York, 11795, United States

RECRUITING

MeSH Terms

Conditions

Neoplasm Metastasis

Interventions

Radiosurgery

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Anurag K Singh

  Roswell Park Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 21, 2019
• First Posted: August 28, 2019
• Study Start: November 18, 2019
• Primary Completion (Estimated): November 18, 2027
• Study Completion (Estimated): November 18, 2027
• Last Updated: April 30, 2026

Record last verified: 2026-04

Locations

US (3)