Single Fraction Stereotactic Body Radiation Therapy After Surgery in Treating Patients With Non-small Cell Lung Cancer

Stage IV Lung Cancer AJCC v8 Clinical Trial

Official title:

A Feasibility and Toxicity Analysis of Single Fraction Stereotactic Body Radiation Therapy for Post-Operative Non-Small Cell Lung Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04073745
• Other study ID #: I 81919
• Secondary ID: NCI-2019-04325I
• Status: Recruiting
• Phase: Phase 1
• Start date: November 6, 2019
• Est. completion date: November 1, 2025

Study information

• Verified date: July 2023
• Source: Roswell Park Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: November 1, 2025
• Est. primary completion date: November 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Lung Non-Small Cell Carcinoma
• Positive Surgical Margin
• Resected Mass
• Stage III Lung Cancer AJCC v8
• Stage IIIA Lung Cancer AJCC v8
• Stage IIIB Lung Cancer AJCC v8
• Stage IIIC Lung Cancer AJCC v8
• Stage IV Lung Cancer AJCC v8
• Stage IVA Lung Cancer AJCC v8
• Stage IVB Lung Cancer AJCC v8

Intervention

Other:
• Quality-of-Life Assessment
Ancillary studies
• Questionnaire Administration
Ancillary studies

Radiation:
• Stereotactic Body Radiation Therapy
Undergo SBRT

Locations

Country	Name	City	State
United States	Roswell Park Cancer Institute	Buffalo	New York

Sponsors (1)

Lead Sponsor	Collaborator
Roswell Park Cancer Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Progression free survival (PFS)	The PFS will be described using standard Kaplan-Meier methodologies. The median survival time, 3-year survival rate, and 5-year survival rate will be estimated and presented with 90% CI.	Up to 5 years
Other	Overall survival (OS)	The OS will be described using standard Kaplan-Meier methodologies. The median survival time, 3-year survival rate, and 5-year survival rate will be estimated and presented with 90% CI.	From SBRT completion until death (event) or end of study/lost to follow-up (censored), assessed up to 5 years
Other	Change in immune markers	Changes in the mediators of tumor antigen presentation, costimulatory molecules, immune effector cell populations, such as CD4+ and CD8+ T-cells, T regulatory cells (CD4+CD25+FoxP3+), natural killer (NK) cells, monocytes, macrophages, dendritic cells (DCs) and myeloid derived suppressor cells (MDSCs) will be measured.	Baseline up to 5 weeks post-SBRT
Primary	Incidence of grade 3 or greater toxicities	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).	Up to 5 years
Primary	Feasibility of single fraction SBRT	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.	Up to 5 years
Secondary	Time to initiation of systemic treatment (TST)	The proportion of patients who have TST < 8 weeks will be recorded. The median time will be presented with a 90% confidence interval (CI).	From the date of surgery until the date of systemic treatment initiation, assessed up to 5 years
Secondary	Quality of life (QoL)	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.	Up to 5 years
Secondary	In-field failure (IFF) rate	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.	Up to 5 years