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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2019-04859 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| I 81318 | Other Identifier | Roswell Park Cancer Institute |
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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.
PRIMARY OBJECTIVES:
I. To assess patient-reported pain response and quality of life (QoL) in patients randomized to either single-fraction stereotactic body radiation therapy (SBRT) or non-SBRT palliative radiation therapy for metastatic disease.
SECONDARY OBJECTIVES:
I. Compare overall survival for patients undergoing single fraction SBRT versus non-SBRT palliative radiation therapy.
EXPLORATORY OBJECTIVES:
I. Assess for changes in immune markers. II. Assess toxicity related to radiation treatment. III. Assess change in frailty index and cognitive function over time in patients undergoing treatment for metastatic cancer.
IV. Evaluate the effect of circadian rhythm and radiation treatment time on outcomes.
V. Assess the utility of the Pain Catastrophizing Index in patients undergoing radiation treatment for metastatic cancer.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients undergo 1, 3-5, 5-6, or 10 fractions of palliative radiation therapy (RT) deemed appropriate by the treating physician.
ARM II: Patients undergo single fraction SBRT.
After completion of study treatment, patients may be followed up at 5 and 12 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I (palliative RT) | Experimental | Patients undergo 1, 3-5, 5-6, or 10 fractions of palliative RT deemed appropriate by the treating physician. |
|
| Arm II (SBRT) | Experimental | Patients undergo single fraction SBRT. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Palliative Radiation Therapy | Radiation | Undergo palliative RT |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | Will be assessed by chart review. Will be carried out using a Cox proportional hazards regression model. | Up to date of last follow-up or date of death, at the time of study analysis, assessed up to 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in immune markers | Changes in the mediators of tumor antigen presentation, costimulatory molecules, immune effector cell populations, such as CD4+ and CD8+ T-cells, T regulatory cells (CD4+CD25+FoxP3+), natural killer cells, monocytes, macrophages, dendritic cells and myeloid derived suppressor cells will be assessed. | Up to 12 weeks |
Inclusion Criteria:
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:
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
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| Name | Affiliation | Role |
|---|---|---|
| Anurag K Singh | Roswell Park Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Roswell Park Cancer Institute | Recruiting | Buffalo | New York | 14263 | United States |
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| Quality-of-Life Assessment |
| Other |
Ancillary studies |
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| Questionnaire Administration | Other | Ancillary studies |
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| Stereotactic Body Radiation Therapy | Radiation | Undergo SBRT |
|
|
| Hospitalization resulting from radiation treatment |
Will be recorded. Any acute (=< 180 days after the end of radiation therapy [RT]) and late (> 180 days after the end of RT) toxicities will be documented using the Cancer Therapy Evaluation Program National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. |
| Up to 12 weeks |
| Cognitive function | Will be measured using combined G8 questionnaire and Montreal Cognitive Assessment assessments. | Up to 12 weeks |
| Pain catastrophizing scale | Will be measured in conjunction with pain endpoints. | Up to 12 weeks |
| Impact of the time of day of treatment on patient outcomes | A retrospective analysis will be used. | Up to 12 weeks |
| Frailty Assessment | Frailty will be determined using the Fried Frailty Index | Up to 12 weeks |
| The Cancer Institute at St. Francis Hospital | Recruiting | East Hills | New York | 11548 | United States |
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| Good Samaritan Hospital | Recruiting | West Islip | New York | 11795 | United States |
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| ID | Term |
|---|---|
| D009362 | Neoplasm Metastasis |
| ID | Term |
|---|---|
| D009385 | Neoplastic Processes |
| D009369 | Neoplasms |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D016634 | Radiosurgery |
| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
| D013238 | Stereotaxic Techniques |
| D019635 | Neurosurgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
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