A Feasibility and Toxicity Analysis of Single Fraction Stereotactic Body Radiation Therapy for Post-Operative Non-Small Cell Lung Cancer
Overview
- Phase
- Phase 1
- Intervention
- Quality-of-Life Assessment
- Conditions
- Lung Non-Small Cell Carcinoma
- Sponsor
- Roswell Park Cancer Institute
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Incidence of grade 3 or greater toxicities
- Status
- Active, not recruiting
- Last Updated
- 2 days ago
Overview
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 involves delivering small doses of daily radiation for several weeks. However, this technique has resulted in inferior outcomes compared to surgery and is associated with damage to surrounding normal lung. Stereotactic body radiation therapy uses special equipment to position a patient and deliver radiation to tumors with high precision. Giving stereotactic body radiation therapy in fewer treatment sessions (single fraction) may kill tumor cells and cause less damage to normal tissue.
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 following post-operative single-fraction SBRT. II. Assess rate of in-field failures. TERTIARY OBJECTIVES: I. Assess progression free survival and overall survival following post-operative SBRT for stage III/IV non-small cell lung cancer (NSCLC). EXPLORATORY OBJECTIVES: I. Changes in the inflammatory markers. OUTLINE: Beginning at least 2 weeks after surgical resection, patients undergo 1 fraction (or 5 fractions every other day if R2 resection of central tumor) of SBRT. After completion of study treatment, patients are followed up at 5 and 12 weeks and then periodically for up to 5 years.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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 Criteria
- •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
Arms & Interventions
Treatment (SBRT)
Beginning at least 2 weeks after surgical resection, patients undergo 1 fraction (or 5 fractions every other day if R2 resection of central tumor) of SBRT.
Intervention: Quality-of-Life Assessment
Treatment (SBRT)
Beginning at least 2 weeks after surgical resection, patients undergo 1 fraction (or 5 fractions every other day if R2 resection of central tumor) of SBRT.
Intervention: Questionnaire Administration
Treatment (SBRT)
Beginning at least 2 weeks after surgical resection, patients undergo 1 fraction (or 5 fractions every other day if R2 resection of central tumor) of SBRT.
Intervention: Stereotactic Body Radiation Therapy
Outcomes
Primary Outcomes
Incidence of grade 3 or greater toxicities
Time Frame: Up to 5 years
Hospitalization resulting from radiation treatment will be recorded. Any acute (=\< 180 days after the end of radiation therapy \[RT\]) and late (\> 180 days after the end of RT) toxicities will be documented using the Cancer Therapy Evaluation Program (CTEP) National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Toxicity rates will be presented with Clopper-Pearson 90% confidence intervals (alpha = 0.10).
Feasibility of single fraction SBRT
Time Frame: Up to 5 years
Feasibility will be assessed by the median time to initiation of systemic treatment (TST) following the combination of surgery and stereotactic body radiation therapy (SBRT), as this interval will reflect the probability of completing intended treatment.
Secondary Outcomes
- Quality of life (QoL)(Up to 5 years)
- In-field failure (IFF) rate(Up to 5 years)
- Time to initiation of systemic treatment (TST)(From the date of surgery until the date of systemic treatment initiation, assessed up to 5 years)