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

Last updated: April 24, 2025
Sponsor: Roswell Park Cancer Institute
Overall Status: Active - Recruiting

Phase

2

Condition

Neoplasms

Treatment

Quality-of-Life Assessment

Stereotactic Body Radiation Therapy

Questionnaire Administration

Clinical Study ID

NCT04068649
I 81318
I 81318
NCI-2019-04859
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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, inwhich radiation may be used for relief or prophylaxis

  • Participants of child-bearing potential must agree to use adequate contraceptivemethods (e.g., hormonal or barrier method of birth control; abstinence) prior tostudy entry. Should a woman become pregnant or suspect she is pregnant while she orher partner is participating in this study, she should inform her treating physicianimmediately

  • Participants with synchronous primary malignancies must have either: 1) documentedcontrol of their second malignancy or 2) have pathological confirmation of themetastatic 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 anIndependent Ethics Committee/Institutional Review Board approved written informedconsent form prior to receiving any study related procedure

Exclusion

Exclusion Criteria:

  • Prior radiation therapy targeting the same area for which radiation treatment isbeing 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 medicationregimens, including type, amount, or frequency of pain medication usage

  • Participants who require or are being planned for surgical stabilization ormetastasectomy of the planned radiation site

  • Severe, active co-morbidity defined as follows:

  • Unstable angina and/or congestive heart failure requiring hospitalizationwithin the last 3 months;

  • Transmural myocardial infarction within the last 3 months;

  • Acute bacterial or fungal infection requiring intravenous antibiotics at thetime of registration;

  • Chronic obstructive pulmonary disease exacerbation or other respiratory illnessrequiring hospitalization or precluding study therapy at the time ofregistration

  • Unwilling or unable to follow protocol requirements

  • Any condition which, in the investigator?s opinion, deems the patient unable toparticipate in enrollment

  • Adults unable to consent

  • Individuals who are not yet adults (infants, children, teenagers)

  • Pregnant women

  • Prisoners

Study Design

Total Participants: 1500
Treatment Group(s): 4
Primary Treatment: Quality-of-Life Assessment
Phase: 2
Study Start date:
November 18, 2019
Estimated Completion Date:
November 18, 2027

Study 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.

Connect with a study center

  • Roswell Park Cancer Institute

    Buffalo, New York 14263
    United States

    Active - Recruiting

  • The Cancer Institute at St. Francis Hospital

    East Hills, New York 11548
    United States

    Active - Recruiting

  • Good Samaritan Hospital

    West Islip, New York 11795
    United States

    Active - Recruiting

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.