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Investigating the Effectiveness of Stereotactic Body Radiotherapy (SBRT) in Addition to Standard of Care Treatment for Cancer That Has Spread Beyond the Original Site of Disease

NCT03808337

Description:

This study is being done to determine if stereotactic body radiotherapy (SBRT) when delivered to all sites of disease in participants with 1-5 metastases will increase the length of time before participants' disease gets worse.

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

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Investigating the Effectiveness of Stereotactic Body Radiotherapy (SBRT) in Addition to Standard of Care Treatment for Cancer That Has Spread Beyond the Original Site of Disease
  • Official Title: A Phase II Randomized Study Assessing the Efficacy of Stereotactic Body Radiotherapy (SBRT) in Patients With Oligometastatic Solid Tumors

Clinical Trial IDs

  • ORG STUDY ID: 18-486
  • NCT ID: NCT03808337

Conditions

  • Triple Negative Breast Cancer
  • Non Small Cell Lung Cancer
  • Metastatic Breast Cancer
  • Metastatic Non-Small Cell Lung Carcinoma

Interventions

DrugSynonymsArms
Systemic Therapy/Standard of CareStandare of Care

Purpose

This study is being done to determine if stereotactic body radiotherapy (SBRT) when delivered to all sites of disease in participants with 1-5 metastases will increase the length of time before participants' disease gets worse.

Trial Arms

NameTypeDescriptionInterventions
Standare of CareActive ComparatorPatients with newly diagnosed metastatic non-small cell lung cancer or triple negative breast cancer may be enrolled on protocol prior to receiving any systemic therapy. If these patients are randomized to the standard of care arm (Arm 1), they will initiate appropriate therapy as determined by their oncologist. Standard of care systemic therapy, including chemotherapeutics, targeted therapies, immunomodulatory agents, and hormonal therapies will be delivered at the discretion of the treating oncologist.
  • Systemic Therapy/Standard of Care
Stereotactic Body Radiotherapy (SBRT) + Standard of CareExperimentalPatients enrolled on Arm 2 of the study will undergo Stereotactic Body Radiotherapy/SBRT to all known metastases seen on imaging studies performed prior to enrollment. Radiotherapy will be given concurrently to all metastatic sites. Minimum BED for ablative SBRT is more than or equal to 48 Gy10. Patients can undergo systemic therapy concurrently with SBRT at the discretion of treating radiation oncologist and medical oncologist. After completion of SBRT to all sites of known metastatic disease, patients will continue standard of care therapy per the treating oncologist.
  • Systemic Therapy/Standard of Care

Eligibility Criteria

        Inclusion Criteria:

          -  Histologically confirmed triple negative breast cancer (TNBC), or non-small cell lung
             cancer (NSCLC) without detectable targetable molecular alterations in EGFR, ALK or
             ROS1.

          -  Pathologically confirmed metastatic disease.

          -  Oligometastatic disease, defined as a maximum of 5 metastatic lesions detected on
             imaging.

          -  Measurable disease by RECIST 1.1 or PERCIST 2.0 criteria

          -  Not yet treated with systemic therapy for metastatic disease, or on systemic therapy
             for metastatic disease without evidence of progression as measured per RECIST 1.1 or
             PERCIST 2.0 criteria.

          -  All metastatic lesions must be defined targets suitable for SBRT prior to
             randomization- unsuitable targets for SBRT may include lesions with indistinct
             borders, or lesions adjacent to prior radiation fields.

          -  ECOG Performance status 0 - 2.

          -  Age >/= 18 years.

          -  Able to provide informed consent.

          -  Female subjects must either be of non-reproductive potential (i.e. post-menopausal by
             history: >/= 60 years old and no menses for 1> year without an alternative medical
             cause; OR history of hysterectomy, OR history of bilateral tubal ligation, OR history
             of bilateral oophorectomy) or must have a negative serum pregnancy test within 2 weeks
             prior to starting treatment.

          -  Adequate baseline organ function to allow SBRT to all relevant targets, as determined
             by the treating radiation oncologist based on lesion location, lesion size, and
             proximity to relevant organs at risk.

        Exclusion Criteria:

          -  Presence of one or more brain metastases

          -  Previous radiotherapy to the intended treatment site that precludes developing a
             treatment plan that respects normal tissue tolerances

          -  Patient unable to tolerate physical set up required for SBRT.

          -  Serious medical co-morbidities precluding radiotherapy, determined at the discretion
             of the treating investigator.

          -  Pregnant or lactating women.

          -  Physical limitation to undergo stereotactic radiotherapy.

          -  Other active malignancy within the last year, even if without evidence of disease.

          -  Inability to treat all sites of active disease with SBRT.

          -  Clinical or radiological evidence of spinal cord compression

          -  Malignant pleural effusion or ascites.

          -  Patients whose entry to the trial will cause unacceptable clinical delays in their
             planned management.
      
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 2 years
Safety Issue:
Description:To determine whether stereotactic body radiotherapy to all sites of metastatic disease in patients with oligometastatic non-small cell lung cancer or triple-negative breast cancer improves progression free survival (PFS), defined as time from randomization to disease progression or death, as compared to standard of care therapy alone.

Secondary Outcome Measures

Measure:Overall Survival
Time Frame:Up to 2 years
Safety Issue:
Description:To compare overall survival (OS) between standard of care and SBRT arms.

Details

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

Trial Keywords

  • Stereotactic body radiotherapy
  • SBRT
  • 18-486
  • Memorial Sloan Kettering Cancer Center

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