Status:
ACTIVE_NOT_RECRUITING
Stereotactic Body Radiation Therapy Followed by Surgery in Treating Patients With Stage I-IIIA Non-small Cell Lung Cancer
Lead Sponsor:
Roswell Park Cancer Institute
Conditions:
Stage I Non-Small Cell Lung Cancer AJCC v7
Stage IA Non-Small Cell Lung Carcinoma AJCC v7
Eligibility:
All Genders
18+ years
Phase:
EARLY_PHASE1
Brief Summary
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 ...
Detailed Description
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 OBJECTIVE...
Eligibility Criteria
Inclusion
- 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)
- Neoadjuvant or induction chemotherapy or biological (immune, vaccine, etc.)therapy for stage IIIa is allowed
- Chemotherapy for another invasive malignancy is permitted if it has been treated definitively and the patient has remained disease free for \>3 years
- 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
- 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 volume of lung or mediastinum currently involved by tumor
- 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(does not apply to neoadjuvant therapy as in inclusion criteria) 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
Key Trial Info
Start Date :
December 18 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 8 2025
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT03348748
Start Date
December 18 2017
End Date
December 8 2025
Last Update
October 29 2025
Active Locations (1)
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1
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263