Single Fraction Stereotactic Body Radiation Therapy After Surgery in Treating Patients With Non-small Cell Lung Cancer
- Conditions
- Stage IIIA Lung Cancer AJCC v8Stage IVA Lung Cancer AJCC v8Stage III Lung Cancer AJCC v8Stage IVB Lung Cancer AJCC v8Resected MassStage IIIB Lung Cancer AJCC v8Stage IIIC Lung Cancer AJCC v8Stage IV Lung Cancer AJCC v8Lung Non-Small Cell CarcinomaPositive Surgical Margin
- Interventions
- Other: Quality-of-Life AssessmentOther: Questionnaire AdministrationRadiation: Stereotactic Body Radiation Therapy
- Registration Number
- NCT04073745
- Lead Sponsor
- Roswell Park Cancer Institute
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 50
-
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
-
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Treatment (SBRT) Stereotactic Body Radiation Therapy 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. Treatment (SBRT) Quality-of-Life Assessment 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. Treatment (SBRT) Questionnaire Administration 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.
- Primary Outcome Measures
Name Time Method Incidence of grade 3 or greater toxicities 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 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 Outcome Measures
Name Time Method Quality of life (QoL) Up to 5 years The QoL scores, from European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) and EORTC QLQ Lung Cancer?Specific Module, and cumulative toxicity rates will be compared be at each time-point (starting 5 weeks after SBRT) between tumor locations using the Mann-Whitney U and Fishers exact tests, respectively. Comparisons of QoL scores between time-points will be made using the Wilcoxon signed rank test. All secondary analysis will be conducted at the 10% significance level. The QoL scores will also be examined for time trends and effects of patient characteristics using regression analysis.
In-field failure (IFF) rate Up to 5 years IFF rate will be reported for the total cohort and at 3- and 5-years. The IFF will be monitored using a Bayesian approach. The monitoring will start after 3 patients have received treatment.
Time to initiation of systemic treatment (TST) From the date of surgery until the date of systemic treatment initiation, assessed up to 5 years The proportion of patients who have TST \< 8 weeks will be recorded. The median time will be presented with a 90% confidence interval (CI).
Trial Locations
- Locations (1)
Roswell Park Cancer Institute
🇺🇸Buffalo, New York, United States