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

Sponsor
Roswell Park Cancer Institute (Other)
Overall Status
Recruiting
CT.gov ID
NCT03348748
Collaborator
(none)
57
1
3
174.9
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Study Details

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.

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

Detailed Description

PRIMARY OBJECTIVES:
  1. To assess the safety and feasibility of combining single fraction stereotactic body radiation therapy (SBRT) followed by surgery, in thoracic malignancies.
SECONDARY OBJECTIVES:
  1. To estimate overall survival (OS) and progression-free survival (PFS) after single fraction SBRT followed by surgery, in thoracic malignancies.

  2. To define any differences in quality of life/toxicity following SBRT based on tumor location/stage/tumor type.

TERTIARY OBJECTIVES:
  1. 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.

Study Design

Study Type:
Interventional
Anticipated 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 :
Dec 18, 2017
Anticipated Primary Completion Date :
Jul 15, 2031
Anticipated Study Completion Date :
Jul 15, 2032

Arms and Interventions

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 Names:
  • 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 Names:
  • 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 Names:
  • 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
  • Outcome Measures

    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 [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 [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 [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) [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 [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 [Up to 10 weeks post-surgery]

      Will be stratified by type of surgery (wedge resection, lobectomy, open versus thoracoscopic, and pneumonectomy).

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Roswell Park Cancer Institute Buffalo New York United States 14263

    Sponsors and Collaborators

    • Roswell Park Cancer Institute

    Investigators

    • Principal Investigator: Anurag Singh, Roswell Park Cancer Institute

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Roswell Park Cancer Institute
    ClinicalTrials.gov Identifier:
    NCT03348748
    Other Study ID Numbers:
    • I 50717
    • NCI-2017-01950
    • I 50717
    First Posted:
    Nov 21, 2017
    Last Update Posted:
    May 4, 2022
    Last Verified:
    May 1, 2022
    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:

    Study Results

    No Results Posted as of May 4, 2022