Clinical Trials /

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: Study of Stereotactic Body Radiation Therapy (SBRT) in Patients With Cancers of the Breast and Lung
  • Official Title: A Randomized Phase II Study Assessing the Efficacy of Local Ablative Radiation Therapy for Non-hematologic Metastatic Cancer Patients With Oligo-progressive Disease

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

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/SBRTExperimentalIn general, we recommend using 9-10 Gy x 3 or 10 Gy x 5 fractions given every other day. Physicians should try to give the highest BED whenever possible while respecting normal tissue tolerance.
    Arm 2:Standard of CareActive ComparatorStandard of care for participant's disease per physician's discretion
    • Standard of care

    Eligibility Criteria

            Inclusion Criteria:
    
              -  Age 18 or older
    
              -  Willing and able to provide informed consent
    
              -  Histologically confirmed metastatic TNBC and NSCLC (without EGFR mutation and ALK
                 rearrangement) with metastatic disease detected on imaging. Biopsy of metastasis prior
                 to enrollment is per treating physician's discretion per standard of care. It is
                 preferred but not required.
    
              -  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
                 oligo-progressive 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.
    
              -  Oligo-progression, 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
    
              -  Oligo-progression in this protocol is defined as:
    
              -  Progression of an individual metastasis according to RECIST 1.1 or PERCIST 1.0
                 criteria
    
              -  Development of a new metastatic lesion at least 5 mm in size.
    
              -  All sites of oligo-progression can be safely treated
    
              -  Maximum 5 progressing metastases in any single non-CNS organ system (i.e. lung, liver,
                 bone).
    
              -  No restriction on the total number of metastases.
    
              -  For patients with brain metastases and oligo-progression 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 oligo-progressive lesions.
    
              -  Any symptomatic metastatic sites requiring prompt palliative radiation (e.g., cord
                 compression) will also be treated prior to randomization. This will not be counted
                 toward the 5 oligo-progressive lesions.
    
            Exclusion Criteria:
    
              -  Pregnancy.
    
              -  Leptomeningeal disease.
    
              -  Pleural disease or peritoneal implants.
    
              -  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 48 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.

    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