Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03348748
Recruitment Status : Recruiting
First Posted : November 21, 2017
Last Update Posted : January 1, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Roswell Park Cancer Institute

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.

Condition or disease Intervention/treatment Phase
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 Other: Laboratory Biomarker Analysis Other: Quality-of-Life Assessment Drug: Stereotactic Body Radiation Therapy Procedure: Thoracic Surgical Procedure Phase 2

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 57 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Three Pilot Studies of Stereotactic Body Radiation Therapy (SBRT) and Surgery in Non-small Cell Lung Cancer
Actual Study Start Date : December 18, 2017
Estimated Primary Completion Date : July 15, 2022
Estimated Study Completion Date : July 15, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arm Intervention/treatment
Experimental: Study 1 (highest-dose of SBRT, surgery)
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.
Other: Laboratory Biomarker Analysis
Correlative studies

Other: Quality-of-Life Assessment
Ancillary studies
Other Name: Quality of Life Assessment

Drug: Stereotactic Body Radiation Therapy
Undergo highest-dose of SBRT
Other Names:
  • SABR
  • SBRT
  • Stereotactic Ablative Body Radiation Therapy

Procedure: Thoracic Surgical Procedure
Undergo thoracic surgery
Other Names:
  • Chest Surgery
  • Thoracic Surgery
  • Thoracic Surgical Procedures

Experimental: Study 2 (lowest-dose of SBRT, surgery)
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.
Other: Laboratory Biomarker Analysis
Correlative studies

Other: Quality-of-Life Assessment
Ancillary studies
Other Name: Quality of Life Assessment

Drug: Stereotactic Body Radiation Therapy
Undergo lowest-dose of SBRT
Other Names:
  • SABR
  • SBRT
  • Stereotactic Ablative Body Radiation Therapy

Procedure: Thoracic Surgical Procedure
Undergo thoracic surgery
Other Names:
  • Chest Surgery
  • Thoracic Surgery
  • Thoracic Surgical Procedures

Experimental: Study 3 (lowest- or higher-dose of SBRT, surgery)
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.
Other: Laboratory Biomarker Analysis
Correlative studies

Other: Quality-of-Life Assessment
Ancillary studies
Other Name: Quality of Life Assessment

Drug: Stereotactic Body Radiation Therapy
Undergo lowest- or higher-dose of SBRT
Other Names:
  • SABR
  • SBRT
  • Stereotactic Ablative Body Radiation Therapy

Procedure: Thoracic Surgical Procedure
Undergo thoracic surgery
Other Names:
  • Chest Surgery
  • Thoracic Surgery
  • Thoracic Surgical Procedures




Primary Outcome Measures :
  1. 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 [ Time Frame: Up to 10 weeks post-surgery ]
    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 :
  1. Overall survival [ Time Frame: Up to 5 years ]
    Will be measured and compared with published historical and contemporaneous rates of toxicity with standard of care therapy for each of the study groups.

  2. Progression free survival [ Time Frame: Up to 5 years ]
    Will be measured and compared with published historical and contemporaneous rates of toxicity with standard of care therapy for each of the study groups.


Other Outcome Measures:
  1. 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) [ Time Frame: Baseline up to 10 weeks post-surgery ]
    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

  2. Factors associated with T cell immunity in pathologic specimens [ Time Frame: After surgery ]
    Comparison will be made to similar, blinded samples from patients who received surgery alone (by means of standard Lung DSRG approval).

  3. Incidence of adverse events assessed using the NCI CTCAE v4.0 [ Time Frame: Up to 10 weeks post-surgery ]
    Will be stratified by type of surgery (wedge resection, lobectomy, open versus thoracoscopic, and pneumonectomy).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
  • 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 lung or mediastinum
  • Previous chemotherapy for this lung or mediastinum tumor; chemotherapy for another invasive malignancy is permitted if it has been treated definitively and the patient has remained disease free for > 3 years
  • 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 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03348748


Locations
Layout table for location information
United States, New York
Roswell Park Cancer Institute Recruiting
Buffalo, New York, United States, 14263
Contact: Anurag K. Singh    716-845-1180    Anurag.Singh@RoswellPark.org   
Principal Investigator: Anurag K. Singh         
Sponsors and Collaborators
Roswell Park Cancer Institute
National Cancer Institute (NCI)
Investigators
Layout table for investigator information
Principal Investigator: Anurag Singh Roswell Park Cancer Institute

Layout table for additonal information
Responsible Party: Roswell Park Cancer Institute
ClinicalTrials.gov Identifier: NCT03348748     History of Changes
Other Study ID Numbers: I 50717
NCI-2017-01950 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
I 50717 ( Other Identifier: Roswell Park Cancer Institute )
P30CA016056 ( U.S. NIH Grant/Contract )
First Posted: November 21, 2017    Key Record Dates
Last Update Posted: January 1, 2019
Last Verified: December 2018

Layout table for additional information
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

Additional relevant MeSH terms:
Layout table for MeSH terms
Carcinoma
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms