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

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ClinicalTrials.gov Identifier: NCT01899989
Recruitment Status : Recruiting
First Posted : July 16, 2013
Last Update Posted : April 8, 2019
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Tracking Information
First Submitted Date  ICMJE July 8, 2013
First Posted Date  ICMJE July 16, 2013
Last Update Posted Date April 8, 2019
Study Start Date  ICMJE July 5, 2013
Estimated Primary Completion Date July 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 17, 2015)
maximum tolerated dose (Cohort A) [ Time Frame: 2 years ]
standard 3+3 dose-escalation scheme
Original Primary Outcome Measures  ICMJE
 (submitted: July 11, 2013)
maximum tolerated dose [ Time Frame: 2 years ]
standard 3+3 dose-escalation scheme
Change History Complete list of historical versions of study NCT01899989 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 17, 2015)
  • ≥ grade 4 or persistent ≥ grade 3 late toxicities (Cohorts A & B) [ Time Frame: ≥3 months post SBRT ]
    All patients will be assessed for toxicities according to CTCAE v 4.0 at least once during SBRT.
  • overall survival (Cohorts A & B) [ Time Frame: 2 years ]
    Response and progression will be evaluated per standard of care for radiographic progression on CT scans.
Original Secondary Outcome Measures  ICMJE
 (submitted: July 11, 2013)
  • ≥ grade 4 or persistent ≥ grade 3 late toxicities [ Time Frame: ≥3 months post SBRT ]
    All patients will be assessed for toxicities according to CTCAE v 4.0 at least once during SBRT.
  • overall survival [ Time Frame: 2 years ]
    Response and progression will be evaluated per standard of care for radiographic progression on CT scans.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Stereotactic Body Radiation Therapy for Inoperable Locally-advanced Non-small Cell Lung Cancer
Official Title  ICMJE Stereotactic Body Radiation Therapy for Inoperable Locally-advanced Non-small Cell Lung Cancer
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Non-small Cell Lung Cancer
Intervention  ICMJE
  • Radiation: Stereotactic Body Radiation Therapy (SBRT)
  • Drug: cisplatin or carboplatin-based
    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.
Study Arms  ICMJE
  • Experimental: A) >5cm,Chemo eligible (closed to accrual)
    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.
    Interventions:
    • Radiation: Stereotactic Body Radiation Therapy (SBRT)
    • Drug: cisplatin or carboplatin-based
  • Experimental: B) 3-5cm OR Chemo ineligible
    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: Radiation: Stereotactic Body Radiation Therapy (SBRT)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 14, 2016)
26
Original Estimated Enrollment  ICMJE
 (submitted: July 11, 2013)
18
Estimated Study Completion Date  ICMJE July 2020
Estimated Primary Completion Date July 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Andreas Rimner, MD 212-639-6025
Contact: Jamie Chaft, MD 646-888-4545
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01899989
Other Study ID Numbers  ICMJE 13-113
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Memorial Sloan Kettering Cancer Center
Study Sponsor  ICMJE Memorial Sloan Kettering Cancer Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Andreas Rimner, MD Memorial Sloan Kettering Cancer Center
PRS Account Memorial Sloan Kettering Cancer Center
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP