Stereotactic Radiosurgery in Treating Patients With Metastatic Breast Cancer, Non-Small Cell Lung Cancer, or Prostate Cancer

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified September 2014 by NRG Oncology
Sponsor:
Collaborator:
Information provided by (Responsible Party):
NRG Oncology
ClinicalTrials.gov Identifier:
NCT02206334
First received: July 30, 2014
Last updated: September 30, 2014
Last verified: September 2014
  Purpose

This phase I clinical trial studies the side effects and the best dose of stereotactic body radiotherapy, also known as stereotactic radiosurgery, in treating patients with breast cancer, non-small cell lung cancer, or prostate cancer that has spread to other parts of the body. Stereotactic radiosurgery delivers fewer, tightly-focused, high doses of radiation therapy to all known sites of cancer in the body. Stereotactic radiosurgery may also kill any remaining tumor cells that are close together or close to an area previously treated with surgery while minimizing radiation exposure of surrounding normal tissue.


Condition Intervention Phase
Adenocarcinoma of the Prostate
Male Breast Cancer
Recurrent Breast Cancer
Recurrent Non-small Cell Lung Cancer
Recurrent Prostate Cancer
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 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 ] [ 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:
  • 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.

  • 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.


Estimated Enrollment: 84
Study Start Date: November 2014
Estimated Primary Completion Date: February 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment (stereotactic radiosurgery)
Patients undergo 3-5 fractions of image-guided stereotactic radiosurgery to all existing metastases over 1-3 weeks with at least 40 hours between treatments for an individual metastasis.
Radiation: stereotactic radiosurgery
Undergo stereotactic radiosurgery (stereotactic body radiation therapy [SBRT])

Detailed Description:

PRIMARY OBJECTIVES:

I. To determine the recommended stereotactic body radiotherapy (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 radiosurgery to all existing metastases over 1-3 weeks with at least 40 hours between treatments for an individual metastasis.

  Eligibility

Ages Eligible for Study:   18 Years and older
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
  • 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
    • 1 radiographically distinct metastasis, which was anatomically close (i.e., with less than or equal to 5 cm of normal tissue between them) to another metastasis that was surgically resected within 90 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
  • 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

Locations
United States, Pennsylvania
NRG Oncology Not yet recruiting
Philadelphia, Pennsylvania, United States, 19103
Contact: Steven J. Chmura    773-702-0817    schmura@radonc.uchicago.edu   
Principal Investigator: Steven J. Chmura         
Sponsors and Collaborators
NRG Oncology
Investigators
Principal Investigator: Steven Chmura NRG Oncology
  More Information

No publications provided

Responsible Party: NRG Oncology
ClinicalTrials.gov Identifier: NCT02206334     History of Changes
Other Study ID Numbers: NRG-BR001, NCI-2014-00702, NRG-BR001, NRG-BR001, U10CA180868, U10CA021661
Study First Received: July 30, 2014
Last Updated: September 30, 2014
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on October 22, 2014