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Stereotactic Body Radiation Therapy for Inoperable Locally-advanced Non-small Cell Lung Cancer

Primary Purpose

Non-small Cell Lung Cancer

Status
Active
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Stereotactic Body Radiation Therapy (SBRT)
cisplatin or carboplatin-based
Sponsored by
Memorial Sloan Kettering Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-small Cell Lung Cancer focused on measuring Stereotactic Body Radiation Therapy (SBRT), Chemotherapy, 13-113

Eligibility Criteria

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

Inclusion Criteria:

All patients:

  • Histologically confirmed non-small cell lung cancer
  • Medically or technically inoperable as per thoracic surgeon or patient's preference not to undergo surgical resection
  • Age ≥ 18 years
  • Women of childbearing potential must have a negative blood pregnancy test
  • Ability to provide written informed consent

Cohort A:

  • Stage IIA-IIIA (TanyN1M0 or T2b-4N0M0) Selected patients with single station N2 nodal involvement in close proximity to the primary tumor target may be considered eligible at the discretion of the PI if all normal tissue guidelines can be met
  • Eligible for chemo-therapy
  • Karnofsky Performance Status ≥70%
  • Men and women of childbearing potential must be willing to use effective contraception while on treatment and for at least 3 months thereafter

  • Patients must show adequate organ function as defined by:

    • Calculated creatinine clearance ≥40 mL/min for patients receiving pemetrexed (by Cockcroft-Gault)
    • Calculated creatinine clearance ≥30 mL/min for patients receiving gemcitabine or paclitaxel (by Cockcroft-Gault) Total bilirubin less than 1.5 x ULN (unless known Gilbert's disease)
    • AST and ALT less than 3 x ULN
    • Absolute neutrophil count greater than 1500/mm3
    • Platelet count greater than 100,000/mm3

Cohort B:

  • T2a-4N0M0 who are not candidates for cohort A or who will not be treated with chemotherapy (due to patient preference or at the recommendation of the treating physician).

Exclusion Criteria:

All patients:

  • Prior radiation therapy to the lungs
  • Prior surgery or chemotherapy for this presentation of lung cancer (history of prior lung cancer that has been treated and deemed inactive by the clinician is acceptable. Recurrent tumors may be treated on protocol as long as SBRT will be the definitive treatment.)
  • N2-3 lymph node involvement based on PET/EBUS-FNA/mediastinoscopy (Any N2 disease that is more than just minimal single station involvement is excluded)
  • Direct tumor extension into including aorta or pulmonary artery
  • Chronic corticosteroid use equivalent to ≥ prednisone 10 mg daily

Prior treatment with a CD137 agonist, ipilimumab, or the CTLA-4 inhibitor, or PD-1/PDL-1 inhibitor

  • Unstable congestive heart failure

Cohort A:

  • Continuous oxygen use

Patients meeting the following exclusion criteria will be excluded from the functional MRI portion only:

  • Metallic implant,exclusions will be determined per institutional policies
  • Pacemaker and defibrillators are excluded
  • Stents etc. will be evaluated according to MSKCC policy
  • Unmanageable claustrophobia
  • High risk for nephrogenic systemic fibrosis

Sites / Locations

  • Memorial Sloan Kettering Cancer Center at Basking Ridge
  • Memorial Sloan Kettering Monmouth
  • Memorial Sloan Kettering Bergen
  • Memorial Sloan Kettering Cancer Center @ Suffolk
  • Memorial Sloan Kettering Westchester
  • Memorial Sloan Kettering Cancer Center
  • Memorial Sloan Kettering at Mercy Medical Center
  • Memorial Sloan Kettering Nassau

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

A) >5cm,Chemo eligible (closed to accrual)

B) 3-5cm OR Chemo ineligible

Arm Description

Patients will receive five fractions of either 8, 10, or 12 Gy to the gross tumor only. Following SBRT patients will be evaluated by their medical oncologist for consideration of adjuvant chemotherapy, starting 6-8 weeks post-RT. All patients will be followed for one year. Patients will be assessed for toxicity by their radiation oncologist at 4 to 6 weeks post-RT and during chemotherapy by their medical oncologist. Follow up after completion of all treatment will consist of CT chest scans at 6 and 12 months post-SBRT and toxicity assessments every 3 months from the end of SBRT for one year.

Using intensity-modulated radiation therapy (IMRT) or volumetric arc therapy (VMAT), the choice of which is determined by the radiation oncologist, patients will be treated in < 5 fractions every other day. The total treatment dose will be between 45 and 54 Gy in < 5 fractions per standard of care. All patients will be followed for one year. Patients will be assessed for toxicity by their radiation oncologist at 4 to 6 weeks post-RT and during chemotherapy at the discretion of their medical oncologist. Follow up after completion of all treatment will consist of CT chest scans at 6 and 12 months post-SBRT and toxicity assessments every 3 months from the end of SBRT for one year. FDG PET/CT scans and Pulmonary Function Tests (PFTs) will be obtained at 3 months and 9 months after SBRT.

Outcomes

Primary Outcome Measures

maximum tolerated dose (Cohort A)
standard 3+3 dose-escalation scheme

Secondary Outcome Measures

≥ grade 4 or persistent ≥ grade 3 late toxicities (Cohorts A & B)
All patients will be assessed for toxicities according to CTCAE v 4.0 at least once during SBRT.
overall survival (Cohorts A & B)
Response and progression will be evaluated per standard of care for radiographic progression on CT scans.

Full Information

First Posted
July 8, 2013
Last Updated
August 1, 2023
Sponsor
Memorial Sloan Kettering Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT01899989
Brief Title
Stereotactic Body Radiation Therapy for Inoperable Locally-advanced Non-small Cell Lung Cancer
Official Title
Stereotactic Body Radiation Therapy for Inoperable Locally-advanced Non-small Cell Lung Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
July 5, 2013 (undefined)
Primary Completion Date
July 2024 (Anticipated)
Study Completion Date
July 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Memorial Sloan Kettering Cancer Center

4. Oversight

5. Study Description

Brief Summary
The purpose of this study is to determine if the use of exploratory immunologic biomarkers, functional MRI images can serve as early predictors for response of NSCLC. It also will provide important information on the perceived side effects from a patient perspective. Patients may participate if they have tumors ≥3 cm without lymph node involvement (for which chemotherapy is not part of the standard of care). Patients will only receive stereotactic body radiation therapy (SBRT) per standard dose guidelines.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-small Cell Lung Cancer
Keywords
Stereotactic Body Radiation Therapy (SBRT), Chemotherapy, 13-113

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
A) >5cm,Chemo eligible (closed to accrual)
Arm Type
Experimental
Arm Description
Patients will receive five fractions of either 8, 10, or 12 Gy to the gross tumor only. Following SBRT patients will be evaluated by their medical oncologist for consideration of adjuvant chemotherapy, starting 6-8 weeks post-RT. All patients will be followed for one year. Patients will be assessed for toxicity by their radiation oncologist at 4 to 6 weeks post-RT and during chemotherapy by their medical oncologist. Follow up after completion of all treatment will consist of CT chest scans at 6 and 12 months post-SBRT and toxicity assessments every 3 months from the end of SBRT for one year.
Arm Title
B) 3-5cm OR Chemo ineligible
Arm Type
Experimental
Arm Description
Using intensity-modulated radiation therapy (IMRT) or volumetric arc therapy (VMAT), the choice of which is determined by the radiation oncologist, patients will be treated in < 5 fractions every other day. The total treatment dose will be between 45 and 54 Gy in < 5 fractions per standard of care. All patients will be followed for one year. Patients will be assessed for toxicity by their radiation oncologist at 4 to 6 weeks post-RT and during chemotherapy at the discretion of their medical oncologist. Follow up after completion of all treatment will consist of CT chest scans at 6 and 12 months post-SBRT and toxicity assessments every 3 months from the end of SBRT for one year. FDG PET/CT scans and Pulmonary Function Tests (PFTs) will be obtained at 3 months and 9 months after SBRT.
Intervention Type
Radiation
Intervention Name(s)
Stereotactic Body Radiation Therapy (SBRT)
Intervention Type
Drug
Intervention Name(s)
cisplatin or carboplatin-based
Intervention Description
Standard chemotherapy with a histology-selected cisplatin or carboplatin-based doublet will be administered intravenously as adjuvant therapy. Gemcitabine will be used for squamous cell carcinomas and pemetrexed will be used for non-squamous non-small cell lung cancer. Cisplatin or carboplatin will be used in combination with the histology-selected agent. The choice of cisplatin or carboplatin will be at the discretion of the treating medical oncologist.
Primary Outcome Measure Information:
Title
maximum tolerated dose (Cohort A)
Description
standard 3+3 dose-escalation scheme
Time Frame
2 years
Secondary Outcome Measure Information:
Title
≥ grade 4 or persistent ≥ grade 3 late toxicities (Cohorts A & B)
Description
All patients will be assessed for toxicities according to CTCAE v 4.0 at least once during SBRT.
Time Frame
≥3 months post SBRT
Title
overall survival (Cohorts A & B)
Description
Response and progression will be evaluated per standard of care for radiographic progression on CT scans.
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: All patients: Histologically confirmed non-small cell lung cancer Medically or technically inoperable as per thoracic surgeon or patient's preference not to undergo surgical resection Age ≥ 18 years Women of childbearing potential must have a negative blood pregnancy test Ability to provide written informed consent Cohort A: Stage IIA-IIIA (TanyN1M0 or T2b-4N0M0) Selected patients with single station N2 nodal involvement in close proximity to the primary tumor target may be considered eligible at the discretion of the PI if all normal tissue guidelines can be met Eligible for chemo-therapy Karnofsky Performance Status ≥70% Men and women of childbearing potential must be willing to use effective contraception while on treatment and for at least 3 months thereafter Patients must show adequate organ function as defined by: Calculated creatinine clearance ≥40 mL/min for patients receiving pemetrexed (by Cockcroft-Gault) Calculated creatinine clearance ≥30 mL/min for patients receiving gemcitabine or paclitaxel (by Cockcroft-Gault) Total bilirubin less than 1.5 x ULN (unless known Gilbert's disease) AST and ALT less than 3 x ULN Absolute neutrophil count greater than 1500/mm3 Platelet count greater than 100,000/mm3 Cohort B: T2a-4N0M0 who are not candidates for cohort A or who will not be treated with chemotherapy (due to patient preference or at the recommendation of the treating physician). Exclusion Criteria: All patients: Prior radiation therapy to the lungs Prior surgery or chemotherapy for this presentation of lung cancer (history of prior lung cancer that has been treated and deemed inactive by the clinician is acceptable. Recurrent tumors may be treated on protocol as long as SBRT will be the definitive treatment.) N2-3 lymph node involvement based on PET/EBUS-FNA/mediastinoscopy (Any N2 disease that is more than just minimal single station involvement is excluded) Direct tumor extension into including aorta or pulmonary artery Chronic corticosteroid use equivalent to ≥ prednisone 10 mg daily Prior treatment with a CD137 agonist, ipilimumab, or the CTLA-4 inhibitor, or PD-1/PDL-1 inhibitor Unstable congestive heart failure Cohort A: Continuous oxygen use Patients meeting the following exclusion criteria will be excluded from the functional MRI portion only: Metallic implant,exclusions will be determined per institutional policies Pacemaker and defibrillators are excluded Stents etc. will be evaluated according to MSKCC policy Unmanageable claustrophobia High risk for nephrogenic systemic fibrosis
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andreas Rimner, MD
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Memorial Sloan Kettering Cancer Center at Basking Ridge
City
Basking Ridge
State/Province
New Jersey
ZIP/Postal Code
07920
Country
United States
Facility Name
Memorial Sloan Kettering Monmouth
City
Middletown
State/Province
New Jersey
ZIP/Postal Code
07748
Country
United States
Facility Name
Memorial Sloan Kettering Bergen
City
Montvale
State/Province
New Jersey
ZIP/Postal Code
07645
Country
United States
Facility Name
Memorial Sloan Kettering Cancer Center @ Suffolk
City
Commack
State/Province
New York
ZIP/Postal Code
11725
Country
United States
Facility Name
Memorial Sloan Kettering Westchester
City
Harrison
State/Province
New York
ZIP/Postal Code
10604
Country
United States
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
Memorial Sloan Kettering at Mercy Medical Center
City
Rockville Centre
State/Province
New York
Country
United States
Facility Name
Memorial Sloan Kettering Nassau
City
Uniondale
State/Province
New York
ZIP/Postal Code
11553
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.mskcc.org/
Description
Memorial Sloan Kettering Cancer Center

Learn more about this trial

Stereotactic Body Radiation Therapy for Inoperable Locally-advanced Non-small Cell Lung Cancer

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