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

NCT ID: NCT01711697

Last Updated: 2021-06-23

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-09-04
• Study Completion Date: 2022-05-31

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:

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.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

stereotactic body radiation therapy

Intervention Type: RADIATION

Undergo SBRT

carboplatin

Intervention Type: DRUG

paclitaxel

Intervention Type: DRUG

radiation therapy

Intervention Type: RADIATION

Undergo radiation therapy

Interventions

stereotactic body radiation therapy

Undergo SBRT

Intervention Type: RADIATION

carboplatin

Intervention Type: DRUG

paclitaxel

Intervention Type: DRUG

radiation therapy

Undergo radiation therapy

Intervention Type: RADIATION

Other Intervention Names

SBRT; stereotactic radiation therapy; stereotactic radiotherapy; Carboplat; CBDCA; JM-8; Paraplat; Paraplatin; Anzatax; Asotax; TAX; Taxol; irradiation; radiotherapy; therapy, radiation

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

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Washington University Siteman Cancer Center

OTHER

Sponsor Role: collaborator

Emory University

OTHER

Sponsor Role: lead

Responsible Party

Kristin Higgins, MD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kristin Higgins, MD

Role: PRINCIPAL_INVESTIGATOR

Emory University

Locations

Grady Health System

Atlanta, Georgia, United States

Emory University Hospital Midtown

Atlanta, Georgia, United States

Emory University Winship Cancer Institute

Atlanta, Georgia, United States

Siteman Cancer Center - Washington University

St Louis, Missouri, United States

Countries

United States

Other Identifiers

NCI-2012-01934

Identifier Type: REGISTRY

Identifier Source: secondary_id

RAD2179-12

Identifier Type: OTHER

Identifier Source: secondary_id

IRB00056552

Identifier Type: -

Identifier Source: org_study_id