Stereotactic Body Radiation Therapy in Treating Patients With Metastatic Breast Cancer, Non-small Cell Lung Cancer, or Prostate Cancer
Information source: NRG Oncology
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: 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: Stereotactic Radiosurgery (Radiation)
Phase: Phase 1
Status: Recruiting
Sponsored by: NRG Oncology Official(s) and/or principal investigator(s): Steven Chmura, Principal Investigator, Affiliation: NRG Oncology
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.
Clinical Details
Official title: A Phase 1 Study of Stereotactic Body Radiotherapy (SBRT) for the Treatment of Multiple Metastases
Study design: Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: 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
Secondary outcome: Rates of >= grade 3 adverse events, scored according to NCI CTCAE v. 4.0Rate of long-term adverse events, scored according to the NCI CTCAE v. 4.0
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
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
- Brachial plexus previously irradiated to > 50 Gy
- Small intestine, large intestine, or stomach previously irradiated to > 45 Gy
- Brain stem previously irradiated to > 50 Gy
- Lung previously irradiated with prior volume 20 Gy (V20Gy) > 30%
- 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
Locations and Contacts
University of Alabama at Birmingham, Birmingham, Alabama 35233, United States; Recruiting Jennifer F. De Los Santos, Phone: 888-823-5923, Email: ctsucontact@westat.com Jennifer F. De Los Santos, Principal Investigator
University of California Davis Comprehensive Cancer Center, Sacramento, California 95817, United States; Recruiting Megan E. Daly, Phone: 916-734-3089 Megan E. Daly, Principal Investigator
University of Florida, Gainesville, Florida 32610, United States; Recruiting Roi Dagan, Phone: 877-686-6009 Roi Dagan, Principal Investigator
Emory University Hospital Midtown, Atlanta, Georgia 30308, United States; Recruiting Pretesh R. Patel, Phone: 404-778-1868 Pretesh R. Patel, Principal Investigator
Emory University/Winship Cancer Institute, Atlanta, Georgia 30322, United States; Recruiting Pretesh R. Patel, Phone: 404-778-1868 Pretesh R. Patel, Principal Investigator
Northwest Community Hospital, Arlington Heights, Illinois 60005, United States; Recruiting Stephen S. Nigh, Phone: 847-618-4968 Stephen S. Nigh, Principal Investigator
University of Chicago Comprehensive Cancer Center, Chicago, Illinois 60637, United States; Recruiting Steven J. Chmura, Phone: 773-834-7424 Steven J. Chmura, Principal Investigator
The James Graham Brown Cancer Center at University of Louisville, Louisville, Kentucky 40202, United States; Recruiting Neal E. Dunlap, Phone: 866-530-5516 Neal E. Dunlap, Principal Investigator
Henry Ford Hospital, Detroit, Michigan 48202, United States; Recruiting Eleanor M. Walker, Phone: 313-916-1784 Eleanor M. Walker, Principal Investigator
Duke University Medical Center, Durham, North Carolina 27710, United States; Recruiting Joseph K. Salama, Phone: 888-275-3853 Joseph K. Salama, Principal Investigator
Ohio State University Comprehensive Cancer Center, Columbus, Ohio 43210, United States; Recruiting Jose G. Bazan, Phone: 800-293-5066, Email: Jamesline@osumc.edu Jose G. Bazan, Principal Investigator
Reading Hospital, West Reading, Pennsylvania 19611, United States; Recruiting Michael L. Haas, Phone: 610-988-9323 Michael L. Haas, Principal Investigator
CHUM - Hopital Notre-Dame, Montreal, Quebec H2L 4M1, Canada; Recruiting Philip Wong, Phone: 514-890-8000ext23611, Email: sylvie.beaudoin.chum@ssss.gouv.qc.ca Philip Wong, Principal Investigator
Additional Information
Starting date: August 2014
Last updated: March 5, 2015
|