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Standard Radiation Therapy Combined With High Dose, Ablative Radiation in Patients With Advanced Lung Cancer That Cannot be Removed by Surgery

This study is currently recruiting participants.
Verified May 2013 by Emory University
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Kristin Higgins, MD, Emory University
ClinicalTrials.gov Identifier:
NCT01711697
First received: October 18, 2012
Last updated: May 9, 2013
Last verified: May 2013
History of Changes
  Purpose

This phase I trial studies the best dose of radiation therapy in treating patients with locally advanced non-small cell lung cancer that cannot be removed by surgery. Radiation therapy uses high energy x rays to kill tumor cells. Specialized radiation therapy, such as stereotactic body radiation therapy (SBRT), that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. SBRT has been shown to provide excellent results when used in early stage lung cancer, but has not yet been applied to patients with more advanced disease.


Condition Intervention Phase
Stage IIA Non-small Cell Lung Cancer
Stage IIB Non-small Cell Lung Cancer
Stage IIIA Non-small Cell Lung Cancer
Stage IIIB Non-small Cell Lung Cancer
 Radiation: stereotactic body radiation therapy
Drug: carboplatin
Drug: paclitaxel
Radiation: radiation therapy
 Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Alternative Radiation Fractionation Strategy for Locally Advanced Non-Small Cell Lung Cancer (NSCLC)

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer
U.S. FDA Resources

Further study details as provided by Emory University:

Primary Outcome Measures:
  • Maximum tolerated dose (MTD) defined to be the dose level that results in a probability equal to 0.33 that a dose limiting toxicity (DLT) will be manifest using Common Terminology Criteria for Adverse Events (CTCAE) version 4 (v.4) [ Time Frame: Up to 1 year ] [ Designated as safety issue: Yes ]
  • Acute toxicities associated with this regimen using CTCAE v.4 [ Time Frame: Up to 90 days ] [ Designated as safety issue: Yes ]
    Crude rates of grade 3 and greater acute toxicities will be reported.

  • Late toxicities associated with this regimen using CTCAE v.4 [ Time Frame: After 90 days ] [ Designated as safety issue: Yes ]
    Crude rates of grade 3 and greater late toxicities will be reported.


Secondary Outcome Measures:
  • Local control [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
    Will be calculated for the entire cohort using Kaplan-Meier methodology.

  • Distant metastasis [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
    Will be calculated for the entire cohort using Kaplan-Meier methodology.

  • Patterns of failure [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
    Will be assessed with standard follow-up imaging, and the percentages of in-field failures versus regional nodal failures calculated.

  • Overall survival [ Time Frame: At 1 year ] [ Designated as safety issue: No ]
    Will be calculated for the entire cohort using Kaplan-Meier methodology.

  • Overall survival [ Time Frame: At 2 years ] [ Designated as safety issue: No ]
    Will be calculated for the entire cohort using Kaplan-Meier methodology.

  • Overall survival [ Time Frame: At 5 years ] [ Designated as safety issue: No ]
    Will be calculated for the entire cohort using Kaplan-Meier methodology.


Estimated Enrollment: 24
Study Start Date: September 2012
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment (radiation therapy, carboplatin, paclitaxel, SBRT)
Patients undergo radiation therapy daily and receive carboplatin and paclitaxel weekly for 4.5 weeks. Patients then undergo 2 boost SBRT treatments 2-3 days apart.
 Radiation: stereotactic body radiation therapy
Undergo SBRT
Other Names:
  • SBRT
  • stereotactic radiation therapy
  • stereotactic radiotherapy
Drug: carboplatin
Other Names:
  • Carboplat
  • CBDCA
  • JM-8
  • Paraplat
  • Paraplatin
Drug: paclitaxel
Other Names:
  • Anzatax
  • Asotax
  • TAX
  • Taxol
Radiation: radiation therapy
Undergo radiation therapy
Other Names:
  • irradiation
  • radiotherapy
  • therapy, radiation

Detailed Description:

PRIMARY OBJECTIVES:

I. To test the safety and tolerability of an alternative fractionation regimen in locally advanced non-small cell lung cancer (NSCLC), consisting of 44 Gy with concurrent chemotherapy followed by a stereotactic body radiation therapy (SBRT) boost to remaining parenchymal and nodal disease. The maximum tolerated dose of the SBRT boost will be determined.

SECONDARY OBJECTIVES:

I. To assess local control. II. To assess distant metastasis and patterns of failure. III. To assess overall survival at 1 and 2 years.

OUTLINE: This is a dose-escalation study of radiation therapy and SBRT.

Patients undergo radiation therapy daily and receive carboplatin and paclitaxel weekly for 4.5 weeks. Patients then undergo 2 boost SBRT treatments 2-3 days apart.

After completion of study treatment, patients are followed up for 5 years.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Biopsy proven NSCLC
  • Unresectable disease
  • Clinical stage T1-T4, N1-3, M0
  • Karnofsky performance status (KPS) >= 70

Exclusion Criteria:

  • Prior history of lung cancer
  • Pregnancy
  • Prior history of radiation to the chest
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01711697

Locations
United States, Georgia
Emory University Recruiting
Atlanta, Georgia, United States, 30322
Contact: Kristin A. Higgins     404-727-5671     kristin.higgins@emory.edu    
Principal Investigator: Kristin A. Higgins            
Sponsors and Collaborators
Emory University
National Cancer Institute (NCI)
Investigators
Principal Investigator: Kristin Higgins Emory University
  More Information

No publications provided

Responsible Party: Kristin Higgins, MD, Principal Investigator, Emory University
ClinicalTrials.gov Identifier: NCT01711697     History of Changes
Other Study ID Numbers: IRB00056552, NCI-2012-01934
Study First Received: October 18, 2012
Last Updated: May 9, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
 Carboplatin
Paclitaxel
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on May 16, 2013