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Stereotactic Body Radiation Therapy Followed by Surgery in Treating Patients With Stage I-IIIA Non-small Cell Lung Cancer

Primary Purpose

Stage I Non-Small Cell Lung Cancer AJCC v7, Stage IA Non-Small Cell Lung Carcinoma AJCC v7, Stage IB Non-Small Cell Lung Carcinoma AJCC v7

Status
Active
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Laboratory Biomarker Analysis
Quality-of-Life Assessment
Stereotactic Body Radiation Therapy
Stereotactic Body Radiation Therapy
Stereotactic Body Radiation Therapy
Thoracic Surgical Procedure
Sponsored by
Roswell Park Cancer Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stage I Non-Small Cell Lung Cancer AJCC v7

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 of =< 2

  • Have histologically proven diagnosis of: non-small cell lung cancer (NSCLC) (stage I, II, or IIIa)

    • Neoadjuvant or induction chemotherapy or biological (immune, vaccine, etc.)therapy for stage IIIa is allowed
    • Chemotherapy for another invasive malignancy is permitted if it has been treated definitively and the patient has remained disease free for >3 years

  • Participant is able to undergo surgery (planned lobectomy or wedge resection)

    • Specifically, the participant has been or will have been cleared for surgery at the time of enrollment; the surgeon can accept the baseline tests done within 45 days prior to SBRT to clear the patient for surgery
  • Participants of child-bearing potential must agree to use adequate contraceptive methods (e.g., hormonal or barrier method of birth control; abstinence) during treatment
  • Participant 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 breathe reproducibly)
  • Previous radiotherapy to the volume of lung or mediastinum currently involved by tumor
  • Previous surgery for this lung or mediastinum tumor
  • Plans for the patient to receive other concomitant antineoplastic therapy (including standard fractionated radiotherapy, chemotherapy, biological therapy, vaccine therapy, and surgery) while on this protocol(does not apply to neoadjuvant therapy as in inclusion criteria) except at disease progression
  • Patients with active systemic, pulmonary, or pericardial infection
  • Pregnant or nursing female participants
  • Unwilling or unable to follow protocol requirements
  • Any condition which in the investigator?s opinion deems the participant ineligible
  • Received an investigational agent within 30 days prior to enrollment
  • Stage IIIb

Sites / Locations

  • Roswell Park Cancer Institute

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Study 1 (highest-dose of SBRT, surgery)

Study 2 (lowest-dose of SBRT, surgery)

Study 3 (lowest- or higher-dose of SBRT, surgery)

Arm Description

Patients with stage I or II NSCLC in the peripheral lung undergo highest-dose of Stereotactic Body Radiation Therapy over a single treatment fraction on day 1. Patients then undergo thoracic surgery on day 28.

Patients with stage I or II NSCLC in the central lung undergo lowest-dose of Stereotactic Body Radiation Therapy over a single treatment fraction on day 1. Patients then undergo thoracic surgery on day 28.

Patients with stage IIIA NSCLC in the any lung location undergo lowest- or higher-dose of Stereotactic Body Radiation Therapy over a single treatment fraction on day 1. Patients then undergo thoracic surgery on day 28.

Outcomes

Primary Outcome Measures

Incidence of treatment-related grade 3-5 adverse events assessed using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version (v)4.0
Comparison will be made with published historical and contemporaneous rates of toxicity with standard of care therapy for each of the study groups.

Secondary Outcome Measures

Overall survival
Will be measured and compared with published historical and contemporaneous rates of toxicity with standard of care therapy for each of the study groups.
Progression free survival
Will be measured and compared with published historical and contemporaneous rates of toxicity with standard of care therapy for each of the study groups.

Full Information

First Posted
November 15, 2017
Last Updated
May 4, 2023
Sponsor
Roswell Park Cancer Institute
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1. Study Identification

Unique Protocol Identification Number
NCT03348748
Brief Title
Stereotactic Body Radiation Therapy Followed by Surgery in Treating Patients With Stage I-IIIA Non-small Cell Lung Cancer
Official Title
Three Pilot Studies of Stereotactic Body Radiation Therapy (SBRT) and Surgery in Non-small Cell Lung Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
December 18, 2017 (Actual)
Primary Completion Date
July 12, 2021 (Actual)
Study Completion Date
August 12, 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
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This pilot clinical trial studies the effects of stereotactic body radiation therapy followed by surgery in treating patients with stage I-IIIA non-small cell lung cancer. Stereotactic body radiation therapy is a method of radiation that uses imaging to precisely locate a tumor and then deliver very high radiation doses to the tumor site in order to limit normal tissue toxicity or damage.
Detailed Description
PRIMARY OBJECTIVES: I. To assess the safety and feasibility of combining single fraction stereotactic body radiation therapy (SBRT) followed by surgery, in thoracic malignancies. SECONDARY OBJECTIVES: I. To estimate overall survival (OS) and progression-free survival (PFS) after single fraction SBRT followed by surgery, in thoracic malignancies. II. To define any differences in quality of life/toxicity following SBRT based on tumor location/stage/tumor type. TERTIARY OBJECTIVES: I. To assess changes in T cell mediated immunity following SBRT in thoracic malignancies. OUTLINE: Patients are assigned to 1 of 3 studies. STUDY 1: Patients with stage I or II non-small cell lung cancer (NSCLC) in the peripheral lung undergo highest-dose of SBRT over a single treatment fraction on day 1. Patients then undergo thoracic surgery on day 28. STUDY 2: Patients with stage I or II NSCLC in the central lung undergo lowest-dose of SBRT over a single treatment fraction on day 1. Patients then undergo thoracic surgery on day 28. STUDY 3: Patients with stage IIIA NSCLC in the any lung location undergo lowest- or higher-dose of SBRT over a single treatment fraction on day 1. Patients then undergo thoracic surgery on day 28. After completion of study treatment, patients are followed up at 6, 9, and 12 months, every 6 months for 2 years, and then annually for 2 years.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stage I Non-Small Cell Lung Cancer AJCC v7, Stage IA Non-Small Cell Lung Carcinoma AJCC v7, Stage IB Non-Small Cell Lung Carcinoma AJCC v7, Stage II Non-Small Cell Lung Cancer AJCC v7, Stage IIA Non-Small Cell Lung Carcinoma AJCC v7, Stage IIB Non-Small Cell Lung Carcinoma AJCC v7, Stage IIIA Non-Small Cell Lung Cancer AJCC v7

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Study 1 (highest-dose of SBRT, surgery)
Arm Type
Experimental
Arm Description
Patients with stage I or II NSCLC in the peripheral lung undergo highest-dose of Stereotactic Body Radiation Therapy over a single treatment fraction on day 1. Patients then undergo thoracic surgery on day 28.
Arm Title
Study 2 (lowest-dose of SBRT, surgery)
Arm Type
Experimental
Arm Description
Patients with stage I or II NSCLC in the central lung undergo lowest-dose of Stereotactic Body Radiation Therapy over a single treatment fraction on day 1. Patients then undergo thoracic surgery on day 28.
Arm Title
Study 3 (lowest- or higher-dose of SBRT, surgery)
Arm Type
Experimental
Arm Description
Patients with stage IIIA NSCLC in the any lung location undergo lowest- or higher-dose of Stereotactic Body Radiation Therapy over a single treatment fraction on day 1. Patients then undergo thoracic surgery on day 28.
Intervention Type
Other
Intervention Name(s)
Laboratory Biomarker Analysis
Intervention Description
Correlative studies
Intervention Type
Other
Intervention Name(s)
Quality-of-Life Assessment
Other Intervention Name(s)
Quality of Life Assessment
Intervention Description
Ancillary studies
Intervention Type
Drug
Intervention Name(s)
Stereotactic Body Radiation Therapy
Other Intervention Name(s)
SABR, SBRT, Stereotactic Ablative Body Radiation Therapy
Intervention Description
Undergo lowest-dose of SBRT
Intervention Type
Drug
Intervention Name(s)
Stereotactic Body Radiation Therapy
Other Intervention Name(s)
SABR, SBRT, Stereotactic Ablative Body Radiation Therapy
Intervention Description
Undergo lowest- or higher-dose of SBRT
Intervention Type
Drug
Intervention Name(s)
Stereotactic Body Radiation Therapy
Other Intervention Name(s)
SABR, SBRT, Stereotactic Ablative Body Radiation Therapy
Intervention Description
Undergo highest-dose of SBRT
Intervention Type
Procedure
Intervention Name(s)
Thoracic Surgical Procedure
Other Intervention Name(s)
Chest Surgery, Thoracic Surgery, Thoracic Surgical Procedures
Intervention Description
Undergo thoracic surgery
Primary Outcome Measure Information:
Title
Incidence of treatment-related grade 3-5 adverse events assessed using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version (v)4.0
Description
Comparison will be made with published historical and contemporaneous rates of toxicity with standard of care therapy for each of the study groups.
Time Frame
Up to 10 weeks post-surgery
Secondary Outcome Measure Information:
Title
Overall survival
Description
Will be measured and compared with published historical and contemporaneous rates of toxicity with standard of care therapy for each of the study groups.
Time Frame
Up to 5 years
Title
Progression free survival
Description
Will be measured and compared with published historical and contemporaneous rates of toxicity with standard of care therapy for each of the study groups.
Time Frame
Up to 5 years
Other Pre-specified Outcome Measures:
Title
Change in the mediators of tumor antigen presentation, co-stimulatory molecules, and immune effector cell populations assessed using multicolor flow cytometry, immunohistochemistry, and enzyme-linked immunosorbent assay (ELISA)
Description
Defined as CD4+ and CD8+ T-cells, T-regulatory cells (CD4+CD25+FoxP3+), natural killer cells, monocytes, macrophages, dendritic cells and myeloid derived suppressor cells. The study groups will be compared with age, sex, and stage matched controls. Immunohistochemistry results, flow cytometry results and ELISA results will be tabulated as percent change pre/post-radiation, and pre/post-thoracic surgery. The effects of these interventions will be assessed using permutation paired t-test, with multiplicity adjustments to maintain a 10% false discovery rate. Adjusted effect sizes will be obtained
Time Frame
Baseline up to 10 weeks post-surgery
Title
Factors associated with T cell immunity in pathologic specimens
Description
Comparison will be made to similar, blinded samples from patients who received surgery alone (by means of standard Lung DSRG approval).
Time Frame
After surgery
Title
Incidence of adverse events assessed using the NCI CTCAE v4.0
Description
Will be stratified by type of surgery (wedge resection, lobectomy, open versus thoracoscopic, and pneumonectomy).
Time Frame
Up to 10 weeks post-surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Have an Eastern Cooperative Oncology Group (ECOG) performance status of =< 2 Have histologically proven diagnosis of: non-small cell lung cancer (NSCLC) (stage I, II, or IIIa) Neoadjuvant or induction chemotherapy or biological (immune, vaccine, etc.)therapy for stage IIIa is allowed Chemotherapy for another invasive malignancy is permitted if it has been treated definitively and the patient has remained disease free for >3 years Participant is able to undergo surgery (planned lobectomy or wedge resection) Specifically, the participant has been or will have been cleared for surgery at the time of enrollment; the surgeon can accept the baseline tests done within 45 days prior to SBRT to clear the patient for surgery Participants of child-bearing potential must agree to use adequate contraceptive methods (e.g., hormonal or barrier method of birth control; abstinence) during treatment Participant 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 breathe reproducibly) Previous radiotherapy to the volume of lung or mediastinum currently involved by tumor Previous surgery for this lung or mediastinum tumor Plans for the patient to receive other concomitant antineoplastic therapy (including standard fractionated radiotherapy, chemotherapy, biological therapy, vaccine therapy, and surgery) while on this protocol(does not apply to neoadjuvant therapy as in inclusion criteria) except at disease progression Patients with active systemic, pulmonary, or pericardial infection Pregnant or nursing female participants Unwilling or unable to follow protocol requirements Any condition which in the investigator?s opinion deems the participant ineligible Received an investigational agent within 30 days prior to enrollment Stage IIIb
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anurag 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

12. IPD Sharing Statement

Learn more about this trial

Stereotactic Body Radiation Therapy Followed by Surgery in Treating Patients With Stage I-IIIA Non-small Cell Lung Cancer

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