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

Emory University

Status and phase: Unknown; Phase 1

Conditions: Stage IIB Non-small Cell Lung Cancer; Stage IIIB Non-small Cell Lung Cancer; Stage IIA Non-small Cell Lung Cancer; Stage IIIA Non-small Cell Lung Cancer

Treatments: Radiation: radiation therapy; Drug: carboplatin; Radiation: stereotactic body radiation therapy; Drug: paclitaxel

Study type: Interventional

Funder types: Other

Identifiers

NCT01711697

IRB00056552

NCI-2012-01934 (Registry Identifier)

RAD2179-12 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 16 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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16 participants in 1 patient group

Treatment (radiation therapy, carboplatin, paclitaxel, SBRT)

Experimental group

Description:

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.

Treatment:

Drug: paclitaxel

Radiation: stereotactic body radiation therapy

Drug: carboplatin

Radiation: radiation therapy