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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 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: September 18, 2014
Last verified: September 2014
  Purpose

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.


Condition Intervention Phase
Non-small Cell Lung Cancer
Radiation: Stereotactic Body Radiation Therapy (SBRT)
Drug: cisplatin or carboplatin-based
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Stereotactic Body Radiation Therapy for Inoperable Locally-advanced Non-small Cell Lung Cancer

Resource links provided by NLM:


Further study details as provided by Memorial Sloan-Kettering Cancer Center:

Primary Outcome Measures:
  • maximum tolerated dose [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    standard 3+3 dose-escalation scheme


Secondary Outcome Measures:
  • ≥ 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.


Estimated Enrollment: 18
Study Start Date: July 2013
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Stereotactic body radiation therapy (SBRT)
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.
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically confirmed non-small cell lung cancer
  • Medically or technically inoperable as per thoracic surgeon or patient's preference not to undergo surgical resection
  • 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
  • Patients must show adequate organ function as defined by:
  • Calculated creatinine clearance≥ 45 mL/min (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
  • Age ≥18 years
  • Karnofsky Performance Status ≥70%
  • 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

Exclusion Criteria:

  • 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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01899989

Contacts
Contact: Andreas Rimner, MD 212-639-6025
Contact: Jamie Chaft, MD 646-888-4545

Locations
United States, New Jersey
Memorial Sloan-Kettering Cancer Center at Basking Ridge Recruiting
Basking Ridge, New Jersey, United States, 07920
Contact: Andreas Rimner, MD    212-639-6025      
United States, New York
Memorial Sloan-Kettering Cancer Center @ Suffolk Recruiting
Commack, New York, United States, 11725
Contact: Andreas Rimner, MD    212-639-6025      
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Andreas Rimner, MD    212-639-6025      
Contact: Jamie Chaft, MD    646-888-4545      
Principal Investigator: Andreas Rimner, MD         
Memorial Sloan-Kettering at Mercy Medical Center Recruiting
Rockville Centre, New York, United States
Contact: Andreas Rimner, MD    212-639-6025      
Contact: Jamie Chaft, MD    646-888-4545      
Principal Investigator: Andreas Rimner, MD         
Memorial Sloan-Kettering Cancer Center at Phelps Memorial Hospital Center Recruiting
Sleepy Hollow, New York, United States, 10591
Contact: Andreas Rimner, MD    212-639-6025      
Contact: .         
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
Investigators
Principal Investigator: Andreas Rimner, MD Memorial Sloan-Kettering Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT01899989     History of Changes
Other Study ID Numbers: 13-113
Study First Received: July 8, 2013
Last Updated: September 18, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Memorial Sloan-Kettering Cancer Center:
Stereotactic Body Radiation Therapy (SBRT)
Chemotherapy
13-113

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Bronchial Neoplasms
Carcinoma, Bronchogenic
Lung Diseases
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Carboplatin
Cisplatin
Antineoplastic Agents
Pharmacologic Actions
Radiation-Sensitizing Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014