Stereotactic Body Radiation Therapy Followed by Surgery in Treating Patients With Stage I-IIIA Non-small Cell Lung Cancer
Status: | Recruiting |
---|---|
Conditions: | Lung Cancer, Lung Cancer |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 1/3/2019 |
Start Date: | December 18, 2017 |
End Date: | July 15, 2023 |
Three Pilot Studies of Stereotactic Body Radiation Therapy (SBRT) and Surgery in Non-small Cell Lung Cancer
This pilot clinical trial studies the effects of stereotactic body radiation therapy followed
by surgery in treating patients with stage I-IIIA non-small cell lung cancer. Stereotactic
body radiation therapy is a method of radiation that uses imaging to precisely locate a tumor
and then deliver very high radiation doses to the tumor site in order to limit normal tissue
toxicity or damage.
by surgery in treating patients with stage I-IIIA non-small cell lung cancer. Stereotactic
body radiation therapy is a method of radiation that uses imaging to precisely locate a tumor
and then deliver very high radiation doses to the tumor site in order to limit normal tissue
toxicity or damage.
PRIMARY OBJECTIVES:
I. To assess the safety and feasibility of combining single fraction stereotactic body
radiation therapy (SBRT) followed by surgery, in thoracic malignancies.
SECONDARY OBJECTIVES:
I. To estimate overall survival (OS) and progression-free survival (PFS) after single
fraction SBRT followed by surgery, in thoracic malignancies.
II. To define any differences in quality of life/toxicity following SBRT based on tumor
location/stage/tumor type.
TERTIARY OBJECTIVES:
I. To assess changes in T cell mediated immunity following SBRT in thoracic malignancies.
OUTLINE: Patients are assigned to 1 of 3 studies.
STUDY 1: Patients with stage I or II non-small cell lung cancer (NSCLC) in the peripheral
lung undergo highest-dose of SBRT over a single treatment fraction on day 1. Patients then
undergo thoracic surgery on day 28.
STUDY 2: Patients with stage I or II NSCLC in the central lung undergo lowest-dose of SBRT
over a single treatment fraction on day 1. Patients then undergo thoracic surgery on day 28.
STUDY 3: Patients with stage IIIA NSCLC in the any lung location undergo lowest- or
higher-dose of SBRT over a single treatment fraction on day 1. Patients then undergo thoracic
surgery on day 28.
After completion of study treatment, patients are followed up at 6, 9, and 12 months, every 6
months for 2 years, and then annually for 2 years.
I. To assess the safety and feasibility of combining single fraction stereotactic body
radiation therapy (SBRT) followed by surgery, in thoracic malignancies.
SECONDARY OBJECTIVES:
I. To estimate overall survival (OS) and progression-free survival (PFS) after single
fraction SBRT followed by surgery, in thoracic malignancies.
II. To define any differences in quality of life/toxicity following SBRT based on tumor
location/stage/tumor type.
TERTIARY OBJECTIVES:
I. To assess changes in T cell mediated immunity following SBRT in thoracic malignancies.
OUTLINE: Patients are assigned to 1 of 3 studies.
STUDY 1: Patients with stage I or II non-small cell lung cancer (NSCLC) in the peripheral
lung undergo highest-dose of SBRT over a single treatment fraction on day 1. Patients then
undergo thoracic surgery on day 28.
STUDY 2: Patients with stage I or II NSCLC in the central lung undergo lowest-dose of SBRT
over a single treatment fraction on day 1. Patients then undergo thoracic surgery on day 28.
STUDY 3: Patients with stage IIIA NSCLC in the any lung location undergo lowest- or
higher-dose of SBRT over a single treatment fraction on day 1. Patients then undergo thoracic
surgery on day 28.
After completion of study treatment, patients are followed up at 6, 9, and 12 months, every 6
months for 2 years, and then annually for 2 years.
Inclusion Criteria:
- Have an Eastern Cooperative Oncology Group (ECOG) performance status of =< 2
- Have histologically proven diagnosis of: non-small cell lung cancer (NSCLC) (stage I,
II, or IIIa)
- Participant is able to undergo surgery (planned lobectomy or wedge resection)
- Specifically, the participant has been or will have been cleared for surgery at
the time of enrollment; the surgeon can accept the baseline tests done within 45
days prior to SBRT to clear the patient for surgery
- Participants of child-bearing potential must agree to use adequate contraceptive
methods (e.g., hormonal or barrier method of birth control; abstinence) during
treatment
- Participant or legal representative must understand the investigational nature of this
study and sign an Independent Ethics Committee/Institutional Review Board approved
written informed consent form prior to receiving any study related procedure
Exclusion Criteria:
- Contraindication to SBRT (this includes the inability to cooperate with any aspect of
SBRT: such as the inability to lie still and breathe reproducibly)
- Previous radiotherapy to the lung or mediastinum
- Previous chemotherapy for this lung or mediastinum tumor; chemotherapy for another
invasive malignancy is permitted if it has been treated definitively and the patient
has remained disease free for > 3 years
- Previous surgery for this lung or mediastinum tumor
- Plans for the patient to receive other concomitant antineoplastic therapy (including
standard fractionated radiotherapy, chemotherapy, biological therapy, vaccine therapy,
and surgery) while on this protocol except at disease progression
- Patients with active systemic, pulmonary, or pericardial infection
- Pregnant or nursing female participants
- Unwilling or unable to follow protocol requirements
- Any condition which in the investigator?s opinion deems the participant ineligible
- Received an investigational agent within 30 days prior to enrollment
- Stage IIIb
We found this trial at
1
site
666 Elm Street
Buffalo, New York 14263
Buffalo, New York 14263
(716) 845-2300
Principal Investigator: Anurag K. Singh
Phone: 716-845-1180
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