Stereotactic Body Radiation Therapy After Surgery in Treating Patients With Stage III-IV Non-small Cell Lung Cancer
Conditions
Recurrent Non-small Cell Lung Cancer - Stage IIIA Non-small Cell Lung Cancer - Stage IIIB Non-small Cell Lung Cancer - Stage IV Non-small Cell Lung Cancer
Conditions: official terms
Carcinoma, Non-Small-Cell Lung - Lung Neoplasms
Study Type
Interventional
Study Phase
N/A
Study Design
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: therapeutic lymphadenectomy Type: Procedure
Name: stereotactic radiosurgery Type: Radiation
Name: quality-of-life assessment Type: Other
Overall Status
Recruiting
Summary
This pilot clinical trial studies stereotactic body radiation therapy after surgery in treating patients with stage III-IV non-small cell lung cancer. Stereotactic radiation therapy may be able to send x-rays directly to the tumor and cause less damage to normal tissue. Lymphadenectomy may remove tumor cells that have spread to nearby lymph nodes in patients with non-small cell lung cancer. Giving stereotactic body radiation therapy after lymphadenectomy may kill any tumor cells that remain after surgery.
Detailed Description
PRIMARY OBJECTIVES:

I. To assess the feasibility/toxicity of combining transcervical extended mediastinal lymphadenectomy (TEMLA) with or without minimally invasive surgery and stereotactic body radiation therapy (SBRT).

SECONDARY OBJECTIVES:

I. To assess time to initiation of chemotherapy following TEMLA with or without minimally invasive surgery and SBRT.

II. To assess feasibility/toxicity of combining TEMLA with or without minimally invasive surgery with various chemotherapy regimens (to be determined by medical oncologist based on patient and tumor characteristics).

III. To estimate survival following TEMLA with or without minimally invasive surgery and SBRT.

IV. To define any differences in quality of life/toxicity following TEMLA with or without minimally invasive surgery and SBRT based on tumor location (peripheral/central).

V. To assess response for primary tumor control and overall survival in TEMLA only patients.

VI. To assess progression free survival for TEMLA/video-assisted thoracoscopic surgery (VATS) patients.

OUTLINE:

Patients undergo TEMLA to remove the mediastinal lymph nodes followed by a single fraction of SBRT to the primary tumor (unless VATS procedure done) and mediastinal lymph node beds (if positive on TEMLA), with or without minimally invasive surgery.

After completion of study treatment, patients are followed up for 3 years and then annually thereafter.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: Inclusion Criteria:

- Have an Eastern Cooperative Oncology Group (ECOG) performance status of =< 2

- Have histologically proven diagnosis of non-small cell lung cancer (NSCLC) (stage III and stage IV [to include limited volume metastases such as brain, bone, adrenal])

- If a level 9 was involved and an alternative minimally invasive surgical procedure is possible, then the patient is eligible; this will be at the discretion of the principal investigator

- Patients of child-bearing potential must agree to use acceptable contraceptive methods (e.g., double barrier) during treatment

- Patient or legal representative must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving and study related procedure

- Patients with chemotherapy prior to TEMLA are eligible

Exclusion Criteria:

- Contraindication to SBRT or TEMLA; this includes the inability to cooperate with any aspect of SBRT such as the inability to lie still and breathe reproducibly

- If patient has an open thoracotomy for lung cancer they will not be able to receive SBRT and will be replaced

- Pregnant or nursing female patients

- Unwilling or unable to follow protocol requirements

- Any condition which the investigator's opinion deems the patient ineligible

- Received an investigational agent within 30 days prior to enrollment
Location
Roswell Park Cancer Institute
Buffalo, New York, United States
Status: Recruiting
Contact: Roswell Park - 877-275-7724 - ASKRPCI@roswellpark.org
Start Date
March 2013
Sponsors
Roswell Park Cancer Institute
Source
Roswell Park Cancer Institute
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page