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

Study Description

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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.

Condition or disease	Intervention/treatment	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

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:

1. To assess local control.
2. To assess distant metastasis and patterns of failure.
3. 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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	16 participants
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	An Alternative Radiation Fractionation Strategy for Locally Advanced Non-Small Cell Lung Cancer (NSCLC)
Study Start Date :	September 2012
Estimated Primary Completion Date :	February 2019
Estimated Study Completion Date :	February 2019

Arms and Interventions

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Arm	Intervention/treatment
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

Outcome Measures

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Primary Outcome Measures :

1. 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 ]
2. Acute toxicities associated with this regimen using CTCAE v.4 [ Time Frame: Up to 90 days ]
   Crude rates of grade 3 and greater acute toxicities will be reported.
3. Late toxicities associated with this regimen using CTCAE v.4 [ Time Frame: After 90 days ]
   Crude rates of grade 3 and greater late toxicities will be reported.

Secondary Outcome Measures :

1. Local control [ Time Frame: Up to 5 years ]
   Will be calculated for the entire cohort using Kaplan-Meier methodology.
2. Distant metastasis [ Time Frame: Up to 5 years ]
   Will be calculated for the entire cohort using Kaplan-Meier methodology.
3. Patterns of failure [ Time Frame: Up to 5 years ]
   Will be assessed with standard follow-up imaging, and the percentages of in-field failures versus regional nodal failures calculated.
4. Overall survival [ Time Frame: At 1 year ]
   Will be calculated for the entire cohort using Kaplan-Meier methodology.
5. Overall survival [ Time Frame: At 2 years ]
   Will be calculated for the entire cohort using Kaplan-Meier methodology.
6. Overall survival [ Time Frame: At 5 years ]
   Will be calculated for the entire cohort using Kaplan-Meier methodology.

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 80 Years (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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

Contacts and Locations

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Locations

United States, Georgia
Grady Health System
Atlanta, Georgia, United States, 30303
Emory University Hospital Midtown
Atlanta, Georgia, United States, 30308
Emory University Winship Cancer Institute
Atlanta, Georgia, United States, 30322
United States, Missouri
Siteman Cancer Center - Washington University
Saint Louis, Missouri, United States, 63110

Sponsors and Collaborators

Emory University

Washington University Siteman Cancer Center

Investigators

Principal Investigator:	Kristin Higgins, MD	Emory University

More Information

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Responsible Party:	Kristin Higgins, MD, Principal Investigator, Emory University
ClinicalTrials.gov Identifier:	NCT01711697 History of Changes
Other Study ID Numbers:	IRB00056552; NCI-2012-01934 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) ); RAD2179-12 ( Other Identifier: Winship Cancer Institute )
First Posted:	October 22, 2012
Last Update Posted:	February 14, 2018
Last Verified:	February 2018

Additional relevant MeSH terms:

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms	Paclitaxel; Albumin-Bound Paclitaxel; Carboplatin; Antineoplastic Agents, Phytogenic; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Molecular Mechanisms of Pharmacological Action