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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2015 by Memorial Sloan Kettering Cancer Center
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT01899989
First received: July 8, 2013
Last updated: August 17, 2015
Last verified: August 2015

July 8, 2013
August 17, 2015
July 2013
July 2016   (final data collection date for primary outcome measure)
maximum tolerated dose (Cohort A) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
standard 3+3 dose-escalation scheme
maximum tolerated dose [ Time Frame: 2 years ] [ Designated as safety issue: No ]
standard 3+3 dose-escalation scheme
Complete list of historical versions of study NCT01899989 on ClinicalTrials.gov Archive Site
  • ≥ grade 4 or persistent ≥ grade 3 late toxicities (Cohorts A & B) [ Time Frame: ≥3 months post SBRT ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    Response and progression will be evaluated per standard of care for radiographic progression on CT scans.
  • ≥ grade 4 or persistent ≥ grade 3 late toxicities [ Time Frame: ≥3 months post SBRT ] [ Designated as safety issue: Yes ]
    All patients will be assessed for toxicities according to CTCAE v 4.0 at least once during SBRT.
  • overall survival [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Response and progression will be evaluated per standard of care for radiographic progression on CT scans.
Not Provided
Not Provided
 
Stereotactic Body Radiation Therapy for Inoperable Locally-advanced Non-small Cell Lung Cancer
Stereotactic Body Radiation Therapy for Inoperable Locally-advanced Non-small Cell Lung Cancer

The purpose of this study is to find out what the maximum dose of stereotactic body radiotherapy (SBRT) is which can be safely given with chemotherapy for the treatment of larger NSCLC. SBRT has become the standard of care for treating inoperable small NSCLCs (tumors for which surgery is not an option), but it is an investigational treatment for larger tumors. The type of chemotherapy the patient receives will be a standard chemotherapy and will be decided by the study doctor.

Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Non-small Cell Lung Cancer
  • 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.
  • Experimental: A) >5cm,Chemo eligible
    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)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
35
July 2016
July 2016   (final data collection date for primary outcome measure)

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
  • Men and women of childbearing potential must be willing to use effective contraception while on treatment and for at least 3 months thereafter
  • 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%
  • 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.

Exclusion Criteria:

All patients:

  • Continuous oxygen use
  • 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

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
Both
18 Years and older
No
Contact: Andreas Rimner, MD 212-639-6025
Contact: Jamie Chaft, MD 646-888-4545
United States
 
NCT01899989
13-113
Not Provided
Memorial Sloan Kettering Cancer Center
Memorial Sloan Kettering Cancer Center
Not Provided
Principal Investigator: Andreas Rimner, MD Memorial Sloan Kettering Cancer Center
Memorial Sloan Kettering Cancer Center
August 2015

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