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An Alternative Radiation Fractionation Strategy for Locally Advanced Non-Small Cell Lung Cancer (NSCLC)

Primary Purpose

Stage IIA Non-small Cell Lung Cancer, Stage IIB Non-small Cell Lung Cancer, Stage IIIA Non-small Cell Lung Cancer

Status
Unknown status
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
stereotactic body radiation therapy
carboplatin
paclitaxel
radiation therapy
Sponsored by
Emory University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stage IIA Non-small Cell Lung Cancer

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Biopsy proven NSCLC, within 8 weeks prior to patient registration
  • Unresectable disease
  • Clinical stage Tx, T1-T4, N1-3, M0
  • Karnofsky performance status (KPS) ≥ 70

  • Pretreatment positron emission tomography (PET) CT scan to rule out metastatic disease

    • The primary tumor may not be larger than 8 cm in maximum dimension
    • If the primary tumor is central in location, defined as within 2 cm from the tracheobronchial tree, it must be no larger than 5 cm
    • Mediastinal and hilar lymphadenopathy can be no larger than 5 cm at any nodal station
  • Pretreatment brain CT with contrast or brain MRI to rule out metastases
  • Pathologic assessment of the mediastinum to document involved nodal stations
  • All of the above inclusion criteria must occur within 8 weeks prior to patient registration, with the exception of pathologic assessment of the mediastinum and biopsy to confirm NSCLC, which can be done within 12 weeks of patient registration

Exclusion Criteria:

  • Prior history of lung cancer
  • Pregnancy
  • Prior history of radiation to the chest

Sites / Locations

  • Grady Health System
  • Emory University Hospital Midtown
  • Emory University Winship Cancer Institute
  • Siteman Cancer Center - Washington University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment (radiation therapy, carboplatin, paclitaxel, SBRT)

Arm Description

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.

Outcomes

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)
Acute toxicities associated with this regimen using CTCAE v.4
Crude rates of grade 3 and greater acute toxicities will be reported.
Late toxicities associated with this regimen using CTCAE v.4
Crude rates of grade 3 and greater late toxicities will be reported.

Secondary Outcome Measures

Local control
Will be calculated for the entire cohort using Kaplan-Meier methodology.
Distant metastasis
Will be calculated for the entire cohort using Kaplan-Meier methodology.
Patterns of failure
Will be assessed with standard follow-up imaging, and the percentages of in-field failures versus regional nodal failures calculated.
Overall survival
Will be calculated for the entire cohort using Kaplan-Meier methodology.
Overall survival
Will be calculated for the entire cohort using Kaplan-Meier methodology.
Overall survival
Will be calculated for the entire cohort using Kaplan-Meier methodology.

Full Information

First Posted
October 18, 2012
Last Updated
June 22, 2021
Sponsor
Emory University
Collaborators
Washington University Siteman Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT01711697
Brief Title
An Alternative Radiation Fractionation Strategy for Locally Advanced Non-Small Cell Lung Cancer (NSCLC)
Official Title
An Alternative Radiation Fractionation Strategy for Locally Advanced Non-Small Cell Lung Cancer (NSCLC)
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Unknown status
Study Start Date
September 4, 2012 (Actual)
Primary Completion Date
May 31, 2022 (Anticipated)
Study Completion Date
May 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Emory University
Collaborators
Washington University Siteman Cancer Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
Detailed Description
PRIMARY OBJECTIVE: 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: To assess local control. To assess distant metastasis and patterns of failure. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment (radiation therapy, carboplatin, paclitaxel, SBRT)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Radiation
Intervention Name(s)
stereotactic body radiation therapy
Other Intervention Name(s)
SBRT, stereotactic radiation therapy, stereotactic radiotherapy
Intervention Description
Undergo SBRT
Intervention Type
Drug
Intervention Name(s)
carboplatin
Other Intervention Name(s)
Carboplat, CBDCA, JM-8, Paraplat, Paraplatin
Intervention Type
Drug
Intervention Name(s)
paclitaxel
Other Intervention Name(s)
Anzatax, Asotax, TAX, Taxol
Intervention Type
Radiation
Intervention Name(s)
radiation therapy
Other Intervention Name(s)
irradiation, radiotherapy, therapy, radiation
Intervention Description
Undergo radiation therapy
Primary Outcome Measure Information:
Title
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
Title
Acute toxicities associated with this regimen using CTCAE v.4
Description
Crude rates of grade 3 and greater acute toxicities will be reported.
Time Frame
Up to 90 days
Title
Late toxicities associated with this regimen using CTCAE v.4
Description
Crude rates of grade 3 and greater late toxicities will be reported.
Time Frame
After 90 days
Secondary Outcome Measure Information:
Title
Local control
Description
Will be calculated for the entire cohort using Kaplan-Meier methodology.
Time Frame
Up to 5 years
Title
Distant metastasis
Description
Will be calculated for the entire cohort using Kaplan-Meier methodology.
Time Frame
Up to 5 years
Title
Patterns of failure
Description
Will be assessed with standard follow-up imaging, and the percentages of in-field failures versus regional nodal failures calculated.
Time Frame
Up to 5 years
Title
Overall survival
Description
Will be calculated for the entire cohort using Kaplan-Meier methodology.
Time Frame
At 1 year
Title
Overall survival
Description
Will be calculated for the entire cohort using Kaplan-Meier methodology.
Time Frame
At 2 years
Title
Overall survival
Description
Will be calculated for the entire cohort using Kaplan-Meier methodology.
Time Frame
At 5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Biopsy proven NSCLC, within 8 weeks prior to patient registration Unresectable disease Clinical stage Tx, T1-T4, N1-3, M0 Karnofsky performance status (KPS) ≥ 70 Pretreatment positron emission tomography (PET) CT scan to rule out metastatic disease The primary tumor may not be larger than 8 cm in maximum dimension If the primary tumor is central in location, defined as within 2 cm from the tracheobronchial tree, it must be no larger than 5 cm Mediastinal and hilar lymphadenopathy can be no larger than 5 cm at any nodal station Pretreatment brain CT with contrast or brain MRI to rule out metastases Pathologic assessment of the mediastinum to document involved nodal stations All of the above inclusion criteria must occur within 8 weeks prior to patient registration, with the exception of pathologic assessment of the mediastinum and biopsy to confirm NSCLC, which can be done within 12 weeks of patient registration Exclusion Criteria: Prior history of lung cancer Pregnancy Prior history of radiation to the chest
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kristin Higgins, MD
Organizational Affiliation
Emory University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Grady Health System
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30303
Country
United States
Facility Name
Emory University Hospital Midtown
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30308
Country
United States
Facility Name
Emory University Winship Cancer Institute
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Siteman Cancer Center - Washington University
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States

12. IPD Sharing Statement

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An Alternative Radiation Fractionation Strategy for Locally Advanced Non-Small Cell Lung Cancer (NSCLC)

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