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.
Brief Title
Stereotactic Body Radiation Therapy in Treating Patients With Metastatic Breast Cancer, Non-small Cell Lung Cancer, or Prostate Cancer
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.
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.
Categories
Completion Date
Completion Date Type
Actual
Conditions
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
Eligibility 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
* 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
Inclusion 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
* 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
Gender
All
Gender Based
false
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT02206334
Org Class
Other
Org Full Name
NRG Oncology
Org Study Id
NRG-BR001
Overall Status
Completed
Phases
Phase 1
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
A Phase 1 Study of Stereotactic Body Radiotherapy (SBRT) for the Treatment of Multiple Metastases
Primary Outcomes
Outcome Description
Adverse events outlined by metastatic location (full detail in protocol) reported as being probably or definitely related to protocol treatment.
Outcome Measure
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
Outcome 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
Secondary Ids
Secondary Id
NCI-2014-00702
Secondary Id
NRG-BR001
Secondary Id
NRG-BR001
Secondary Id
U10CA180868
Secondary Id
U10CA021661
Secondary Outcomes
Outcome Description
Adverse events reported as being possibly, probably, or definitely related to protocol treatment.
Outcome Time Frame
Up to 2 years from end of treatment; analysis occurs after all patients have been potentially followed for 2 years from registration
Outcome Measure
Rate of long-term adverse events, scored according to the NCI CTCAE v. 4.0
Outcome Description
Adverse events (other than DLTs) reported as being possibly, probably, or definitely related to protocol treatment.
Outcome 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
Outcome Measure
Rates of >= grade 3 adverse events, scored according to NCI CTCAE v. 4.0
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Estimated
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Nitin Ohri
Investigator Email
nitin.ohri@einsteinmed.org
Investigator Phone