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Randomized Study of Stereotactic Body Radiation Therapy (SBRT) in Patients With Oligoprogressive Metastatic Cancers of the Breast and Lung

NCT03808662

Description:

The purpose of this study is determine if receiving stereotactic body radiation(SBRT) when participants' metastatic tumors have just begun to grow increase the length of time before disease gets worse

Related Conditions:
  • Breast Carcinoma
  • Non-Small Cell Lung Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Randomized Study of Stereotactic Body Radiation Therapy (SBRT) in Patients With Oligoprogressive Metastatic Cancers of the Breast and Lung
  • Official Title: Precision Radiation for OligoMetastatIc and MetaStatic DiseasE (PROMISE)-004: Consolidative Use of Radiotherapy to Block (CURB) Oligoprogression

Clinical Trial IDs

  • ORG STUDY ID: 18-431
  • NCT ID: NCT03808662

Conditions

  • TNBC - Triple-Negative Breast Cancer
  • Triple Negative Breast Cancer
  • NSCLC
  • NSCLC Stage IV
  • Non Small Cell Lung Cancer
  • Non Small Cell Lung Cancer Metastatic
  • NSCLC Stage IV Without EGFR/ALK Mutation

Interventions

DrugSynonymsArms
Standard of careArm 2:Standard of Care

Purpose

The purpose of this study is determine if receiving stereotactic body radiation(SBRT) when participants' metastatic tumors have just begun to grow increase the length of time before disease gets worse

Trial Arms

NameTypeDescriptionInterventions
Arm 1: Early Stereotactic Body Radiotherapy/SBRTExperimentalSBRT to all oligoprogressive sites
    Arm 2:Standard of CareActive Comparator
    • Standard of care

    Eligibility Criteria

            Inclusion Criteria:
    
              -  Age 18 or older
    
              -  Willing and able to provide informed consent
    
              -  Metastatic disease detected on imaging and histologically confirmed:
    
            Triple negative breast cancer TNBC (ER <1%, PR <1%, her-2-neu 0- 1+ by IHC or FISH-negative
            or as determined by MD discretion)
    
            OR NSCLC (without known EGFR mutation or ALK/ROS1 rearrangement)
    
            OR ER+ breast cancer patients who progressed during chemotherapy, regardless of HER2 status
    
            OR NSCLC with EGFR, ALK, or ROS1 targetable molecular alterations with disease progression
            on first-line tyrosine kinase inhibitor
    
            Note:
    
              -  Biopsy of metastasis prior to enrollment is per treating physician's discretion per
                 standard of care. It is preferred but not required.
    
              -  These patients are selected for the study given the similar survival outcomes when
                 given standard of care therapies
    
              -  Patient has received at least first-line prior treatment with systemic therapy (either
                 cytotoxic or targeted, including maintenance therapies).
    
              -  Patients who received prior immunotherapy are allowed.
    
              -  Patients who had any prior radiation therapy near or overlapping with the
                 oligoprogressive sites are allowed to enroll.
    
              -  Patients with the following medical conditions precluding them from participating in
                 other systemic therapy or drug trials are allowed:
    
              -  active liver disease, including viral or other hepatitis, or cirrhosis
    
              -  any other significant medical condition not under control, including any acute
                 coronary syndrome within the past 6 months.
    
              -  a permanent pacemaker
    
              -  a QTc > 480 ms in the baseline EKG
    
              -  peripheral neuropathy of grade >/= 2 per NCI CTCAE
    
              -  history or known autoimmune disease
    
              -  current chronic systemic steroid therapy or any immunosuppressive therapy
    
              -  history of primary immunodeficiency or solid organ transplant
    
              -  known positive human immunodeficiency virus (HIV), chronic or active hepatitis B or C,
                 or active hepatitis A
    
              -  active infection requiring systemic antibiotic therapy
    
              -  Patients can have more than 5 metastases but can only have 1-5 oligo-progressive
                 lesions.
    
              -  Oligoprogression, defined as Response Evaluation Criteria in Solid Tumors (RECIST) or
                 Positron Emission Tomography Response Criteria in Solid Tumors (PERCIST) documented
                 progression in up to 5 individual lesions
    
            Using Response Evaluation Criteria in Solid Tumors (RECIST) Criteria as a guide:
    
              1. At least a 20% increase in the sum of the longest diameter (LD) of the lesion, taking
                 as reference the smallest sum LD recorded since the last imaging OR
    
              2. The appearance of one or more new lesions OR
    
              3. New/malignant FDG uptake in the absence of other indications of progressive disease or
                 an anatomically stable lesion OR
    
              4. >/= 5mm increase in the diameter sum of the lesion
    
            OR
    
            Using Positron Emission Tomography Response Criteria in Solid Tumors (PERCIST) as a guide:
    
              1. >30% increase in 18F-FDG SUV peak, with >0.8 SUV units increase in tumor SUV from the
                 baseline scan in pattern typical of tumor and not of infection/treatment effect OR
    
              2. Visible increase in the extent of 18F-FDG tumor uptake OR
    
              3. New 18F-FDG avid lesions typical of cancer (including new bone lesion) and not related
                 to treatment effect and/or infection
    
            OR
    
            Development of a new soft tissue metastatic lesion at least 5mm in size or any new bone
            metastasis
    
            OR
    
            Progressive enlargement of a known metastasis on 2 consecutive imaging studies at least 2
            months apart with a minimum 5mm increase in size
    
              -  All sites of oligoprogression can be safely treated
    
              -  Maximum 5 progressing metastases in any single extra-cranial organ system (i.e. lung,
                 liver, bone)
    
              -  No restriction on the total number of metastases
    
              -  For patients with brain metastases and oligoprogression elsewhere where stereotactic
                 radiation to the brain is warranted, the brain lesions can be treated prior to
                 randomization. This will not be counted toward the 5 progressive lesions.
    
              -  Any symptomatic metastatic sites requiring prompt palliative radiation (e.g. cord
                 compression) can also be treated with standard of care radiation prior to
                 randomization. This will not be counted toward the 5 progressive lesions.
    
            Exclusion Criteria:
    
              -  Pregnancy.
    
              -  Leptomeningeal disease.
    
              -  Serious medical comorbidities precluding radiotherapy, such as ataxia-telangiectasia
                 or scleroderma.
    
              -  Any other condition which in the judgment of the investigator would make the patient
                 inappropriate for entry into this study.
          
    Maximum Eligible Age:N/A
    Minimum Eligible Age:18 Years
    Eligible Gender:All
    Healthy Volunteers:No

    Primary Outcome Measures

    Measure:Progression Free Survival
    Time Frame:Up to 52 weeks after final participant is enrolled
    Safety Issue:
    Description:To study if the addition of early SBRT to extra-cranial oligo-progressive metastatic disease could prolong PFS compared to no SBRT. PFS is defined as the time from randomization to disease progression or death.

    Secondary Outcome Measures

    Measure:Overall survival
    Time Frame:From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
    Safety Issue:
    Description:

    Details

    Phase:Phase 2
    Primary Purpose:Interventional
    Overall Status:Recruiting
    Lead Sponsor:Memorial Sloan Kettering Cancer Center

    Trial Keywords

    • SBRT
    • Stereotactic Body Radiotherapy
    • Non-hematology metatstatic cancer
    • non-CNS oligo-progressive disease
    • intracranial metastatic disease
    • Memorial Sloan Kettering Cancer Center
    • 18-431

    Last Updated

    January 8, 2020