Clinical trial NCT01711697: An Alternative Radiation Fractionation Strategy for Locally Advanced Non-Small Cell Lung Cancer (NSCLC)
Official title: An Alternative Radiation Fractionation Strategy for Locally Advanced Non-Small Cell Lung Cancer (NSCLC)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
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
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: Washington University Siteman Cancer Center
First posted: 2012-10-22
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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
* 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

Primary outcomes:
measure: 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)
timeFrame: Up to 1 year
measure: Acute toxicities associated with this regimen using CTCAE v.4
timeFrame: Up to 90 days
measure: Late toxicities associated with this regimen using CTCAE v.4
timeFrame: After 90 days
Secondary outcomes:
measure: Local control
timeFrame: Up to 5 years
measure: Distant metastasis
timeFrame: Up to 5 years
measure: Patterns of failure
timeFrame: Up to 5 years
measure: Overall survival
timeFrame: At 1 year
measure: Overall survival
timeFrame: At 2 years
measure: Overall survival
timeFrame: At 5 years
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Grady Health System
state: Georgia
city: Atlanta
country: United States
facility: Emory University Hospital Midtown
state: Georgia
city: Atlanta
country: United States
facility: Emory University Winship Cancer Institute
state: Georgia
city: Saint Louis
country: United States
facility: Siteman Cancer Center - Washington University
state: Missouri
Study officials:
affiliation: Emory University
name: Kristin Higgins, MD
role: PRINCIPAL_INVESTIGATOR
References: