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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2016 by NRG Oncology
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
NRG Oncology
ClinicalTrials.gov Identifier:
NCT02206334
First received: July 30, 2014
Last updated: June 17, 2016
Last verified: June 2016
  Purpose
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.

Condition Intervention Phase
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
Radiation: Stereotactic Radiosurgery
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 1 Study of Stereotactic Body Radiotherapy (SBRT) for the Treatment of Multiple Metastases

Resource links provided by NLM:


Further study details as provided by NRG Oncology:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
    Adverse events outlined by metastatic location (full detail in protocol) reported as being probably or definitely related to protocol treatment.


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    Adverse events (other than DLTs) reported as being possibly, probably, or definitely related to protocol treatment.


Estimated Enrollment: 84
Study Start Date: August 2014
Estimated Primary Completion Date: February 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment (stereotactic body radiation therapy)
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.
Radiation: Stereotactic Radiosurgery
Undergo SBRT
Other Names:
  • Stereotactic External Beam Irradiation
  • stereotactic external-beam radiation therapy
  • Stereotactic Radiation Therapy
  • Stereotactic Radiotherapy
  • stereotaxic radiation therapy
  • stereotaxic radiosurgery

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.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02206334

  Show 58 Study Locations
Sponsors and Collaborators
NRG Oncology
National Cancer Institute (NCI)
Investigators
Principal Investigator: Steven Chmura NRG Oncology
  More Information

Responsible Party: NRG Oncology
ClinicalTrials.gov Identifier: NCT02206334     History of Changes
Other Study ID Numbers: NRG-BR001  NCI-2014-00702  NRG BR001  NRG-BR001  NRG-BR001  U10CA180868  U10CA021661 
Study First Received: July 30, 2014
Last Updated: June 17, 2016
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Breast Neoplasms
Carcinoma
Lung Neoplasms
Prostatic Neoplasms
Carcinoma, Non-Small-Cell Lung
Adenocarcinoma
Breast Neoplasms, Male
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Respiratory Tract Neoplasms
Thoracic Neoplasms
Lung Diseases
Respiratory Tract Diseases
Genital Neoplasms, Male
Urogenital Neoplasms
Genital Diseases, Male
Prostatic Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms

ClinicalTrials.gov processed this record on July 24, 2016