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Stereotactic Body Radiation Therapy in Treating Patients With Metastatic Breast Cancer, Non-small Cell Lung Cancer, or Prostate Cancer

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ClinicalTrials.gov Identifier: NCT02206334
Recruitment Status : Active, not recruiting
First Posted : August 1, 2014
Last Update Posted : March 1, 2021
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
NRG Oncology

Tracking Information
First Submitted Date  ICMJE July 30, 2014
First Posted Date  ICMJE August 1, 2014
Last Update Posted Date March 1, 2021
Actual Study Start Date  ICMJE August 2014
Actual Primary Completion Date December 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 5, 2015)
Dose-limiting toxicity (DLT) scored according to the National Cancer Institute (NCI) CTCAE version 4.0 for each of 7 metastatic locations when multiple metastases are treated with SBRT [ Time Frame: Within 6 months from the start of treatment; for each of the 7 metastatic locations, analysis occurs after 6 evaluable patients have been followed for a minimum of 6 months from the start of treatment ]
Adverse events outlined by metastatic location (full detail in protocol) reported as being probably or definitely related to protocol treatment.
Original Primary Outcome Measures  ICMJE
 (submitted: July 30, 2014)
Dose-limiting toxicity (DLT) scored according to the National Cancer Institute (NCI) CTCAE version 4.0 for each of 7 metastatic locations when multiple metastases are treated with stereotactic radiosurgery [ Time Frame: Within 6 months from the start of treatment; for each of the 7 metastatic locations, analysis occurs after 6 evaluable patients have been followed for a minimum of 6 months from the start of treatment ]
Adverse events outlined by metastatic location (full detail in protocol) reported as being probably or definitely related to protocol treatment.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 29, 2016)
  • Rate of long-term adverse events, scored according to the NCI CTCAE v. 4.0 [ Time Frame: Up to 2 years from end of treatment; analysis occurs after all patients have been potentially followed for 2 years from registration ]
    Adverse events reported as being possibly, probably, or definitely related to protocol treatment.
  • Rates of >= grade 3 adverse events, scored according to NCI CTCAE v. 4.0 [ Time Frame: Within 6 months from the start of treatment; analysis occurs after all patients have been followed for a minimum of 6 months from the start of treatment ]
    Adverse events (other than DLTs) reported as being possibly, probably, or definitely related to protocol treatment.
Original Secondary Outcome Measures  ICMJE
 (submitted: July 30, 2014)
  • Rates of >= grade 3 adverse events, scored according to NCI CTCAE v. 4.0 [ Time Frame: Within 6 months from the start of treatment; analysis occurs after all patients have been followed for a minimum of 6 months from the start of treatment ]
    Adverse events (other than DLTs) reported as being possibly, probably, or definitely related to protocol treatment.
  • Rate of long-term adverse events, scored according to the NCI CTCAE v. 4.0 [ Time Frame: Up to 2 years from end of treatment; analysis occurs after all patients have been potentially followed for 2 years from registration ]
    Adverse events reported as being possibly, probably, or definitely related to protocol treatment.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Stereotactic Body Radiation Therapy in Treating Patients With Metastatic Breast Cancer, Non-small Cell Lung Cancer, or Prostate Cancer
Official Title  ICMJE A Phase 1 Study of Stereotactic Body Radiotherapy (SBRT) for the Treatment of Multiple Metastases
Brief Summary This phase I trial studies the side effects and the best dose of stereotactic body radiation therapy in treating patients with breast cancer, non-small cell lung cancer, or prostate cancer that has spread to other parts of the body. Stereotactic body radiation therapy delivers fewer, tightly-focused, high doses of radiation therapy to all known sites of cancer in the body while minimizing radiation exposure of surrounding normal tissue.
Detailed Description

PRIMARY OBJECTIVES:

I. To determine the recommended stereotactic body radiation therapy (SBRT) dose for each of the metastatic locations being treated given the individual and overlapping fields when multiple metastases are treated with SBRT in a national clinical trials network setting.

SECONDARY OBJECTIVES:

I. To estimate rates of >= grade 3 Common Terminology Criteria for Adverse Events (CTCAE), version (v.) 4.0 adverse events other than a dose-limiting toxicity (DLT) which is possibly, probably, or definitely related to treatment and which occurs within 6 months from the start of SBRT to multiple metastases.

II. To estimate the rates of long-term adverse events occurring up to 2 years from the end of SBRT.

III. To explore the most appropriate and clinically relevant technological parameters to ensure quality and effectiveness throughout radiation therapy processes, including imaging, simulation, patient immobilization, target and critical structure definition, treatment planning, image guidance and delivery.

OUTLINE:

Patients undergo 3-5 fractions of image-guided stereotactic body radiation therapy to all existing metastases over 1-3 weeks with at least 40 hours between treatments for an individual metastasis.

After completion of study treatment, patients are followed up at 35-45 days and then every 3 months for 2 years.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Male Breast Carcinoma
  • Prostate Adenocarcinoma
  • Recurrent Breast Carcinoma
  • Recurrent Non-Small Cell Lung Carcinoma
  • Recurrent Prostate Carcinoma
  • Stage IV Breast Cancer
  • Stage IV Non-Small Cell Lung Cancer
  • Stage IV Prostate Cancer
Intervention  ICMJE Radiation: Stereotactic Body Radiation Therapy (SBRT)
Undergo SBRT
Other Names:
  • Stereotactic External Beam Irradiation
  • stereotactic external-beam radiation therapy
  • Stereotactic Radiation Therapy
  • stereotactic radiosurgery
  • Stereotactic Radiotherapy
  • stereotaxic radiation therapy
  • stereotaxic radiosurgery
  • SBRT
Study Arms  ICMJE Experimental: Stereotactic Body Radiation Therapy (SBRT)
Patients undergo 3-5 fractions of image-guided stereotactic body radiation therapy to all existing metastases over 1-3 weeks with at least 40 hours between treatments for an individual metastasis.
Intervention: Radiation: Stereotactic Body Radiation Therapy (SBRT)
Publications * Chmura S, Winter KA, Robinson C, Pisansky TM, Borges V, Al-Hallaq H, Matuszak M, Park SS, Yi S, Hasan Y, Bazan J, Wong P, Yoon HA, Horton J, Gan G, Milano MT, Sigurdson ER, Moughan J, Salama JK, White J. Evaluation of Safety of Stereotactic Body Radiotherapy for the Treatment of Patients With Multiple Metastases: Findings From the NRG-BR001 Phase 1 Trial. JAMA Oncol. 2021 Apr 22. doi: 10.1001/jamaoncol.2021.0687. [Epub ahead of print]

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: March 21, 2018)
42
Original Estimated Enrollment  ICMJE
 (submitted: July 30, 2014)
84
Estimated Study Completion Date  ICMJE December 2023
Actual Primary Completion Date December 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Metastatic breast cancer (MBC) OR metastatic non-small cell lung cancer (NSCLC) OR metastatic adenocarcinoma of the prostate; the sites of allowed metastases are: peripheral lung, central lung, mediastinal/cervical lymph node, liver, spinal/paraspinal, osseous, and abdominal-pelvic

    • NOTE: after the required number of evaluable patients have been accrued for a given dose level, the accrual for that metastatic location will be temporarily suspended while the safety of that dose level is assessed; a patient can only be entered onto the trial if all of their metastatic locations are open to accrual (e.g. if central lung is temporarily suspended for safety assessment and the patient has a central lung metastases, regardless of other metastases, they cannot enroll until the safety of dose to central lung is determined)
  • Primary tumor site without progression at registration
  • All metastases not resected must be amenable to SBRT
  • The patient must meet ONE of the three following criteria:

    • 3-4 radiographically distinct metastases of any distribution in the allowed anatomical sites OR
    • 2 radiographically distinct metastases that must be anatomically close (i.e., with less than or equal to 5 cm of normal tissue between them) OR
    • 3 or 4 distinct metastasis, 2 or 3 to be treated with SBRT and the other (s) having been surgically removed
  • Evaluation by a radiation oncologist within 45 days prior to study registration
  • Evaluation by a medical oncologist within 45 days prior to study registration
  • The following imaging workup to document metastases within 45 days prior to study registration:

    • Computed tomography (CT) scans of the chest, abdomen and pelvis with radionuclide bone scan OR whole body positron emission tomography (PET)/CT
  • History/physical examination within 45 days prior to study registration
  • Zubrod performance status =< 2 within 45 days prior to study registration
  • Age >= 18 years
  • Absolute neutrophil count (ANC) >= 500 cells/mm^3
  • Platelets >= 50,000 /mm^3
  • Hemoglobin >= 8.0 g/dl (Note: the use of transfusion or other intervention to achieve hemoglobin [Hgb] >= 8.0 g/dl is acceptable)
  • If liver metastases present, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) must be < 3 x upper limit of normal (ULN)
  • Patient must provide study specific informed consent prior to study entry
  • For females of child-bearing potential, negative serum/urine pregnancy test within 14 days prior to study registration

Exclusion Criteria:

  • Progression of primary tumor site (breast, prostate, or lung) at time of registration
  • Metastases with indistinct borders making targeting not feasible
  • Known brain metastases
  • Prior palliative radiotherapy to metastases
  • Metastases located within 3 cm of the previously irradiated structures:

    • Spinal cord previously irradiated to > 40 Gy (delivered in =< 3 Gy/fraction)
    • Brachial plexus previously irradiated to > 50 Gy (delivered in =< 3 Gy/fraction)
    • Small intestine, large intestine, or stomach previously irradiated to > 45 Gy (delivered in =< 3 Gy/fraction)
    • Brain stem previously irradiated to > 50 Gy (delivered in =< 3 Gy/fraction)
    • Whole lung previously irradiated with prior volume 20 Gy (V20Gy) > 30% (delivered in =< 3 Gy/fraction)
    • Primary tumor irradiated with SBRT
    • Metastasis irradiated with SBRT
  • Severe, active co-morbidity, defined as follows:

    • Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months prior to registration
    • Transmural myocardial infarction within the last 6 months prior to registration
    • 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 within 30 days prior to registration
    • Severe hepatic disease, defined as a diagnosis of Child-Pugh class B or C hepatic disease
    • Human immunodeficiency virus (HIV) positive with cluster of differentiation (CD) 4 count < 200 cells/microliter; note that patients who are HIV positive are eligible, provided they are under treatment with highly active antiretroviral therapy (HAART) and have a CD4 count >= 200 cells/microliter within 30 days prior to registration; note also that HIV testing is not required for eligibility for this protocol
    • End-stage renal disease (i.e., on dialysis or dialysis has been recommended)
  • Pregnancy or women of childbearing potential not willing/able to use medically acceptable forms of contraception during protocol treatment or for at least 6 months following treatment
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   Switzerland,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02206334
Other Study ID Numbers  ICMJE NRG-BR001
NCI-2014-00702 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
NRG-BR001 ( Other Identifier: NRG Oncology )
NRG-BR001 ( Other Identifier: CTEP )
U10CA180868 ( U.S. NIH Grant/Contract )
U10CA021661 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party NRG Oncology
Study Sponsor  ICMJE NRG Oncology
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Principal Investigator: Steven Chmura NRG Oncology
PRS Account NRG Oncology
Verification Date February 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP