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

Status

UNKNOWN

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01711697

Enrollment

Registered

2012-10-22

Start date

2012-09-04

Completion date

2022-05-31

Last updated

2021-06-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

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.

Interventions

RADIATIONstereotactic body radiation therapy

Undergo SBRT

DRUGcarboplatin

DRUGpaclitaxel

RADIATIONradiation therapy

Undergo radiation therapy

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

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

Design outcomes

Primary

Measure	Time frame	Description
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	—
Acute toxicities associated with this regimen using CTCAE v.4	Up to 90 days	Crude rates of grade 3 and greater acute toxicities will be reported.
Late toxicities associated with this regimen using CTCAE v.4	After 90 days	Crude rates of grade 3 and greater late toxicities will be reported.

Secondary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026