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

• ClinicalTrials.gov Identifier: NCT04068649
• Recruitment Status: Recruiting
• First Posted: August 28, 2019
• Last Update Posted: July 27, 2020
• Sponsor: Roswell Park Cancer Institute
• Information provided by (Responsible Party): Roswell Park Cancer Institute

Tracking Information

• First Submitted Date: August 21, 2019
• First Posted Date: August 28, 2019
• Last Update Posted Date: July 27, 2020
• Actual Study Start Date: November 18, 2019
• Estimated Primary Completion Date: September 9, 2024 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: August 22, 2019)

• 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.
• 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.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: August 22, 2019)

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.

• Original Secondary Outcome Measures: Same as current

Current Other Pre-specified Outcome Measures (submitted: August 22, 2019)

• 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.
• 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.
• Cognitive function [ Time Frame: Up to 12 weeks ]
  Will be measured using combined G8 questionnaire and Montreal Cognitive Assessment assessments.
• Pain catastrophizing scale [ Time Frame: Up to 12 weeks ]
  Will be measured in conjunction with pain endpoints.
• Impact of the time of day of treatment on patient outcomes [ Time Frame: Up to 12 weeks ]
  A retrospective analysis will be used.
• Frailty Assessment [ Time Frame: Up to 12 weeks ]
  Frailty will be determined using the Fried Frailty Index

• Original Other Pre-specified Outcome Measures: Same as current

Descriptive Information

• Brief Title: Single-Fraction SBRT Versus Standard Palliative Radiation Therapy in Treating Patients With Metastatic Cancer
• 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)
• 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.

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.

• Study Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Non-Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Metastatic Malignant Neoplasm

Intervention

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

  • SABR
  • SBRT
  • Stereotactic Ablative Body Radiation Therapy

Study Arms

• Experimental: Arm I (palliative RT)
  Patients undergo 1, 3-5, 5-6, or 10 fractions of palliative RT deemed appropriate by the treating physician.
  Interventions:

  • Radiation: Palliative Radiation Therapy
  • Other: Quality-of-Life Assessment
  • Other: Questionnaire Administration
• Experimental: Arm II (SBRT)
  Patients undergo single fraction SBRT.
  Interventions:

  • Other: Quality-of-Life Assessment
  • Other: Questionnaire Administration
  • Radiation: Stereotactic Body Radiation Therapy

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: August 22, 2019): 1500
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: September 9, 2025
• Estimated Primary Completion Date: September 9, 2024 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Listed Location Countries: United States

Administrative Information

• NCT Number: 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 )
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• 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

• IPD Sharing Statement: Not Provided
• Responsible Party: Roswell Park Cancer Institute
• Study Sponsor: Roswell Park Cancer Institute
• Collaborators: Not Provided

Investigators

• Principal Investigator: Anurag K Singh; Roswell Park Cancer Institute

• PRS Account: Roswell Park Cancer Institute
• Verification Date: July 2020