RATIONALE: Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Giving paclitaxel and carboplatin together with radiation therapy before surgery may shrink the tumor so that it can be removed. Giving chemotherapy after surgery may kill any tumor cells remaining after surgery. PURPOSE: This phase II trial is studying how well giving paclitaxel and carboplatin together with radiation therapy works in treating patients who are undergoing surgery for stage III non-small cell lung cancer.
OBJECTIVES: * Determine the mediastinal node clearance rate in patients with stage IIIA or IIIB non-small cell lung cancer treated with neoadjuvant induction chemoradiotherapy comprising paclitaxel, carboplatin, and high-dose radiotherapy followed by surgical resection for patients found to be resectable and consolidative chemotherapy comprising paclitaxel and carboplatin. * Determine the rate of complete pathological response in patients treated with this regimen. * Determine the feasibility of surgical resection after neoadjuvant induction chemoradiotherapy in these patients. * Determine disease-free and overall survival of patients treated with this regimen. * Determine the toxicity of this regimen in these patients.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
60
Arizona Oncology Services Foundation
Phoenix, Arizona, United States
Virginia G. Piper Cancer Center at Scottsdale Healthcare - Shea
Scottsdale, Arizona, United States
USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles, California, United States
Mayo Clinic - Jacksonville
Jacksonville, Florida, United States
Tallahassee Memorial Hospital
Tallahassee, Florida, United States
Cancer Institute at St. John's Hospital
Springfield, Illinois, United States
Greenebaum Cancer Center at University of Maryland Medical Center
Baltimore, Maryland, United States
Saint Joseph Mercy Cancer Center
Ann Arbor, Michigan, United States
CCOP - Michigan Cancer Research Consortium
Ann Arbor, Michigan, United States
Mayo Clinic Cancer Center
Rochester, Minnesota, United States
...and 12 more locations
Mediastinal Nodal Clearance Rate
If at least 12 of the first 21 evaluable patients and at least 27 of the the first 45 evaluable patients have mediastinal nodal clearance (MNC), then a conclusion of a 70% MNC rate (compared to 50%) is made using Simon's two-stage design with 90% power and 10% type I error.
Time frame: At completion of concurrent chemotherapy and radiation therapy, up to 14 weeks.
Percentage of Patients With Complete Pathological Response After Concurrent Chemotherapy and Radiation Therapy
Complete pathologic response is defined as complete resection achieved and no evidence of viable tumor in the entire resection specimen.
Time frame: At time of surgery (16-18 weeks)
Percentage of Patients With Major Surgical Morbidities Within 30 Days of Surgery
The surgical morbidities occurring within 30 days following resection were assessed and graded using the NCI Common Toxicity Criteria for Adverse Effects (CTCAE) v3.0. A major morbidity is considered a grade 3 or higher of any of the following: pneumonitis, infection, atelectasis, chest tube drainage/bronchial stump leak, pneumothorax, chylothorax, cardiac ischemia/infarction, pulmonary thrombosis/embolism, supraventricular atrial arrhythmia, ventricular arrhythmia, post-operative hemorrhage, pulmonary/upper respiratory fistula, pleural effusion, or death.
Time frame: From 0 to 30 days following surgery (surgery occurs within 16-18 weeks after registration)
Percentage of Patients Able to Undergo Surgical Resection
Time frame: At time of surgery (16-18 weeks)
Distribution of R0, R1, and R2 Resections After Chemotherapy
An R0 resection is defined as a complete resection of all disease with negative margins and the highest lymph node resected negative for residual tumor. An R1 resection is defined as a complete resection of all disease with pathology of positive margins, pathologic evidence of tumor cells in the highest lymph node resected in the mediastinum, or extracapsular nodal spread. An R2 resection is defined as gross residual disease left behind after surgical resection.
Time frame: At time of surgery (16-18 weeks)
Overall Survival at Two Years
Overall survival time is defined as time from registration to the date of death from any cause. Overall survival rate is estimated by the Kaplan-Meier method. Patients last known to be alive are censored at the date of last contact.
Time frame: From registration to two years
Progression-free Survival at Two Years
Progression is defined as at least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started, or the appearance of one or more new lesions. An event for progression-free survival is the first occurrence of progression or death due to any cause. Progression-free survival time is defined as the time from study entry to the the date progression or death, or last known follow-up (censored) if neither progression nor death occurred. Progression-free survival rate is estimated using the Kaplan-Meier method.
Time frame: From registration to two years
Distribution of Highest Grade Adverse Event
The number of patients whose highest grade adverse event (AE) reported was 3, 4, or 5 was calculated. Adverse events were graded using the Common Terminology Criteria for Adverse Events (CTCAE) v3.0. Grade refers to the severity of the AE. The CTCAE v3.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild, Grade 2 Moderate, Grade 3 Severe, Grade 4 Life-threatening or disabling, Grade 5 Death related to AE. Number of patients with highest grade of 3, 4, and 5 are presented.
Time frame: From start of treatment to end of follow-up, a maximum of 64.3 months
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