Status:
ACTIVE_NOT_RECRUITING
Single Fraction Stereotactic Body Radiation Therapy After Surgery in Treating Patients With Non-small Cell Lung Cancer
Lead Sponsor:
Roswell Park Cancer Institute
Conditions:
Lung Non-Small Cell Carcinoma
Positive Surgical Margin
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This trial studies the side effects of single fraction stereotactic body radiation therapy after surgery in treating patients with non-small cell lung cancer. Standard radiation for lung cancer involv...
Detailed Description
PRIMARY OBJECTIVES: I. Assess feasibility and toxicity of single-fraction stereotactic body radiation therapy (SBRT) in the post-operative setting. SECONDARY OBJECTIVES: I. Assess quality of life f...
Eligibility Criteria
Inclusion
- Have an Eastern Cooperative Oncology Group (ECOG) performance status =\< 2
- Has completed curative-intent surgical resection of lung primary with pathologic diagnosis of NSCLC disease, with pathology to include at least 1 of the following:
- Close (\<=2 mm) or Positive surgical margin (R1/R2) or pathologic N2 disease (with or without extracapsular extension \[ECE\])
- Anatomic pulmonary resection (lobectomy or pneumonectomy) preferred, although sublobar resection is allowed at the discretion of the treating surgeon. Systemic lobe-specific nodal sampling is required. A minimum of 3 N2 stations must be sampled. Selective lymph node dissection should be completed for patients with known N2 disease
- Women of child-bearing potential must agree to use adequate contraceptive methods (e.g., hormonal or barrier method of birth control; abstinence)
- Patient or legal representative must be willing and able to participate in protocol requirements, including pre- and post-treatment survey evaluations and clinical assessments
- Patient 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 breath reproducibly
- Prior radiation therapy targeting the same area for which radiation treatment is being planned
- Pregnant or nursing female patients
- Unwilling or unable to follow protocol requirements
- Any condition which, in the investigator?s opinion, deems the patient unable to participate in enrollment
- Patients who undergo sublobar resection but are unable to undergo appropriate N1 and N2 lymph node sampling
Key Trial Info
Start Date :
December 4 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 27 2025
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT04073745
Start Date
December 4 2019
End Date
December 27 2025
Last Update
September 10 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263