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

  • STATUS
    Recruiting
  • End date
    Nov 18, 2025
  • participants needed
    1500
  • sponsor
    Roswell Park Cancer Institute
Updated on 9 May 2022
cancer
metastasis
tumor cells

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.

Description

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.

Details
Condition Metastatic Malignant Neoplasm
Treatment questionnaire administration, quality-of-life assessment, stereotactic body radiation therapy, Palliative Radiation Therapy
Clinical Study IdentifierNCT04068649
SponsorRoswell Park Cancer Institute
Last Modified on9 May 2022

Eligibility

Yes No Not Sure

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
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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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