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

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:

Genetics Home Reference related topics: lung cancer

MedlinePlus related topics: Cancer Lung Cancer

Drug Information available for: Paclitaxel Carboplatin

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 2018
Estimated Primary Completion Date:	September 2017 (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 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.

Eligibility


Ages Eligible for Study:	18 Years to 80 Years (Adult, Senior)
Genders Eligible for Study:	Both
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

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: NCT01711697

Contacts


Contact: Kristin Higgins, MD	404-778-3473	kristin.higgins@emory.edu

Locations


United States, Georgia
Grady Health System	Recruiting
Atlanta, Georgia, United States, 30303
Contact: Kristin Higgins, MD 404-778-3473 kristin.higgins@emory.edu
Emory University Hospital Midtown	Recruiting
Atlanta, Georgia, United States, 30308
Contact: Kristin Higgins, MD 404-778-3473 kristin.higgins@emory.edu
Emory University Winship Cancer Institute	Recruiting
Atlanta, Georgia, United States, 30322
Contact: Kristin Higgins, MD 404-778-3473 kristin.higgins@emory.edu
United States, Missouri
Siteman Cancer Center - Washington University	Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Jeff Bradley, MD jbradley@radonc.wustl.edu

Sponsors and Collaborators

Emory University

Investigators


Principal Investigator:	Kristin Higgins, MD	Emory University

More Information


Responsible Party:	Kristin Higgins, MD, Principal Investigator, Emory University
ClinicalTrials.gov Identifier:	NCT01711697 History of Changes
Other Study ID Numbers:	IRB00056552 NCI-2012-01934 RAD2179-12
Study First Received:	October 18, 2012
Last Updated:	May 3, 2016
Health Authority:	United States: Food and Drug Administration United States: Institutional Review Board United States: Data and Safety Monitoring Board

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

ClinicalTrials.gov processed this record on September 30, 2016