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

Stage IIIB Non-small Cell Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01711697
• Other study ID #: IRB00056552
• Secondary ID: NCI-2012-01934RA
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: September 4, 2012
• Est. completion date: May 31, 2022

Study information

• Verified date: June 2021
• Source: Emory University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 16
• Est. completion date: May 31, 2022
• Est. primary completion date: May 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• 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

Intervention

Radiation:
• stereotactic body radiation therapy
Undergo SBRT

Drug:
• carboplatin

• paclitaxel

Radiation:
• radiation therapy
Undergo radiation therapy

Locations

Country	Name	City	State
United States	Emory University Hospital Midtown	Atlanta	Georgia
United States	Emory University Winship Cancer Institute	Atlanta	Georgia
United States	Grady Health System	Atlanta	Georgia
United States	Siteman Cancer Center - Washington University	Saint Louis	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
Emory University	Washington University Siteman Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)		Up to 1 year
Primary	Acute toxicities associated with this regimen using CTCAE v.4	Crude rates of grade 3 and greater acute toxicities will be reported.	Up to 90 days
Primary	Late toxicities associated with this regimen using CTCAE v.4	Crude rates of grade 3 and greater late toxicities will be reported.	After 90 days
Secondary	Local control	Will be calculated for the entire cohort using Kaplan-Meier methodology.	Up to 5 years
Secondary	Distant metastasis	Will be calculated for the entire cohort using Kaplan-Meier methodology.	Up to 5 years
Secondary	Patterns of failure	Will be assessed with standard follow-up imaging, and the percentages of in-field failures versus regional nodal failures calculated.	Up to 5 years
Secondary	Overall survival	Will be calculated for the entire cohort using Kaplan-Meier methodology.	At 1 year
Secondary	Overall survival	Will be calculated for the entire cohort using Kaplan-Meier methodology.	At 2 years
Secondary	Overall survival	Will be calculated for the entire cohort using Kaplan-Meier methodology.	At 5 years