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

Primary Purpose

Lung Non-Small Cell Carcinoma, Positive Surgical Margin, Resected Mass

Status

Recruiting

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Quality-of-Life Assessment

Questionnaire Administration

Stereotactic Body Radiation Therapy

About this trial

This is an interventional treatment trial for Lung Non-Small Cell Carcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Roswell Park Cancer InstituteRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment (SBRT)

Arm Description

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.

Outcomes

Primary Outcome Measures

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).

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.

Secondary Outcome Measures

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).

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.

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.

Full Information

NCT ID

NCT04073745

First Posted

August 27, 2019

Last Updated

July 28, 2023

Sponsor

Roswell Park Cancer Institute

1. Study Identification

Unique Protocol Identification Number

NCT04073745

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2023

Overall Recruitment Status

Recruiting

Study Start Date

November 6, 2019 (Actual)

Primary Completion Date

November 1, 2024 (Anticipated)

Study Completion Date

November 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Roswell Park Cancer Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Treatment (SBRT)

Arm Type

Experimental

Arm Description

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 Type

Other

Intervention Name(s)

Quality-of-Life Assessment

Other Intervention Name(s)

Quality of Life Assessment

Intervention Description

Ancillary studies

Intervention Type

Other

Intervention Name(s)

Questionnaire Administration

Intervention Description

Ancillary studies

Intervention Type

Radiation

Intervention Name(s)

Stereotactic Body Radiation Therapy

Other Intervention Name(s)

SABR, SBRT, Stereotactic Ablative Body Radiation Therapy

Intervention Description

Undergo SBRT

Primary Outcome Measure Information:

Title

Incidence of grade 3 or greater toxicities

Description

Time Frame

Up to 5 years

Title

Feasibility of single fraction SBRT

Description

Time Frame

Up to 5 years

Secondary Outcome Measure Information:

Title

Time to initiation of systemic treatment (TST)

Description

The proportion of patients who have TST < 8 weeks will be recorded. The median time will be presented with a 90% confidence interval (CI).

Time Frame

From the date of surgery until the date of systemic treatment initiation, assessed up to 5 years

Title

Quality of life (QoL)

Description

Time Frame

Up to 5 years

Title

In-field failure (IFF) rate

Description

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 Frame

Up to 5 years

Other Pre-specified Outcome Measures:

Title

Progression free survival (PFS)

Description

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.

Time Frame

Up to 5 years

Title

Overall survival (OS)

Description

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.

Time Frame

From SBRT completion until death (event) or end of study/lost to follow-up (censored), assessed up to 5 years

Title

Change in immune markers

Description

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.

Time Frame

Baseline up to 5 weeks post-SBRT

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Anurag K Singh

Organizational Affiliation

Roswell Park Cancer Institute

Official's Role

Principal Investigator

Facility Information:

Facility Name

Roswell Park Cancer Institute

City

Buffalo

State/Province

New York

ZIP/Postal Code

14263

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Anurag K. Singh

Phone

716-845-3218

Anurag.Singh@roswellpark.org

First Name & Middle Initial & Last Name & Degree

Anurag K. Singh

12. IPD Sharing Statement

Learn more about this trial

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

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