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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04068649
Recruitment Status : Recruiting
First Posted : August 28, 2019
Last Update Posted : July 2, 2020
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Roswell Park Cancer Institute

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.

Condition or disease Intervention/treatment Phase
Metastatic Malignant Neoplasm Radiation: Palliative Radiation Therapy Other: Quality-of-Life Assessment Other: Questionnaire Administration Radiation: Stereotactic Body Radiation Therapy Phase 2

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1500 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2 Randomized Study With a Non-randomized Cohort : Assessing Single-Fraction SBRT Versus Standard Palliative Radiation in Patients With Metastatic Disease (ASTEROID)
Actual Study Start Date : November 18, 2019
Estimated Primary Completion Date : September 9, 2024
Estimated Study Completion Date : September 9, 2025

Arm Intervention/treatment
Experimental: Arm I (palliative RT)
Patients undergo 1, 3-5, 5-6, or 10 fractions of palliative RT deemed appropriate by the treating physician.
Radiation: Palliative Radiation Therapy
Undergo palliative RT

Other: Quality-of-Life Assessment
Ancillary studies
Other Name: Quality of Life Assessment

Other: Questionnaire Administration
Ancillary studies

Experimental: Arm II (SBRT)
Patients undergo single fraction SBRT.
Other: Quality-of-Life Assessment
Ancillary studies
Other Name: Quality of Life Assessment

Other: Questionnaire Administration
Ancillary studies

Radiation: Stereotactic Body Radiation Therapy
Undergo SBRT
Other Names:
  • SABR
  • SBRT
  • Stereotactic Ablative Body Radiation Therapy




Primary Outcome Measures :
  1. Pain responses [ Time Frame: Baseline up to 12 weeks ]
    Will be quantified using the pain scales from the Brief Pain Inventory (BPI). Will be an analysis-of-covariance.

  2. Change in Quality of life [ Time Frame: Baseline up to 12 weeks ]
    Will be measured with European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30. Will be an analysis-of-covariance.


Secondary Outcome Measures :
  1. Overall survival [ Time Frame: Up to date of last follow-up or date of death, at the time of study analysis, assessed up to 12 weeks ]
    Will be assessed by chart review. Will be carried out using a Cox proportional hazards regression model.


Other Outcome Measures:
  1. Changes in immune markers [ Time Frame: Up to 12 weeks ]
    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.

  2. Hospitalization resulting from radiation treatment [ Time Frame: Up to 12 weeks ]
    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.

  3. Cognitive function [ Time Frame: Up to 12 weeks ]
    Will be measured using combined G8 questionnaire and Montreal Cognitive Assessment assessments.

  4. Pain catastrophizing scale [ Time Frame: Up to 12 weeks ]
    Will be measured in conjunction with pain endpoints.

  5. Impact of the time of day of treatment on patient outcomes [ Time Frame: Up to 12 weeks ]
    A retrospective analysis will be used.

  6. Frailty Assessment [ Time Frame: Up to 12 weeks ]
    Frailty will be determined using the Fried Frailty Index



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  • Patients 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
  • Patient or legal representative must be willing and able to participate in protocol requirements, including pre- and post-treatment survey evaluations and clinical assessments
  • Patient or legal representative 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
  • Patients who are unable to accurately or reliably recount their pain medication regimens, including type, amount, or frequency of pain medication usage
  • Patients 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04068649


Locations
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United States, New York
Roswell Park Cancer Institute Recruiting
Buffalo, New York, United States, 14263
Contact: Anurag K. Singh    716-845-3218    Anurag.Singh@roswellpark.org   
Principal Investigator: Anurag K. Singh         
The Cancer Institute at St. Francis Hospital Recruiting
East Hills, New York, United States, 11548
Contact: Anne Vinokur, MD    516-222-2020    anne.vinokur@chsli.org   
Sponsors and Collaborators
Roswell Park Cancer Institute
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Anurag K Singh Roswell Park Cancer Institute
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Responsible Party: Roswell Park Cancer Institute
ClinicalTrials.gov Identifier: NCT04068649    
Other Study ID Numbers: I 81318
NCI-2019-04859 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
I 81318 ( Other Identifier: Roswell Park Cancer Institute )
P30CA016056 ( U.S. NIH Grant/Contract )
First Posted: August 28, 2019    Key Record Dates
Last Update Posted: July 2, 2020
Last Verified: June 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Neoplasms