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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

1500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-11-18

Study Completion Date

2027-11-18

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Metastatic Malignant Neoplasm

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Arm I (palliative RT)

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

Group Type EXPERIMENTAL

Palliative Radiation Therapy

Intervention Type RADIATION

Undergo palliative RT

Quality-of-Life Assessment

Intervention Type OTHER

Ancillary studies

Questionnaire Administration

Intervention Type OTHER

Ancillary studies

Arm II (SBRT)

Patients undergo single fraction SBRT.

Group Type EXPERIMENTAL

Quality-of-Life Assessment

Intervention Type OTHER

Ancillary studies

Questionnaire Administration

Intervention Type OTHER

Ancillary studies

Stereotactic Body Radiation Therapy

Intervention Type RADIATION

Undergo SBRT

Interventions

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Palliative Radiation Therapy

Undergo palliative RT

Intervention Type RADIATION

Quality-of-Life Assessment

Ancillary studies

Intervention Type OTHER

Questionnaire Administration

Ancillary studies

Intervention Type OTHER

Stereotactic Body Radiation Therapy

Undergo SBRT

Intervention Type RADIATION

Other Intervention Names

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Quality of Life Assessment SABR SBRT Stereotactic Ablative Body Radiation Therapy

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No