A Phase II Trial Of Neoadjuvant Therapy With Concurrent Chemotherapy And High Dose Radiotherapy Followed By Surgical Resection And Consolidative Therapy For Locally Advanced Non-Small Cell Lung Carcinoma
- 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
- 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.
OUTLINE: This is a multicenter study.
- Induction chemoradiotherapy: Patients undergo high-dose radiotherapy (including a total
of 6 fractions of boost radiotherapy after large field radiotherapy) once daily, 5 days
a week, for approximately 7 weeks. Beginning on the first day of radiotherapy, patients
also receive paclitaxel IV over 1 hour and carboplatin IV over 30 minutes once weekly
for 6 weeks. Patients are reassessed 4 weeks after the completion of induction
chemoradiotherapy. Patients with resectable tumors undergo surgery within 2 weeks of
reassessment and then receive consolidation chemotherapy no later than 10 weeks after
surgery. Patients with unresectable tumors proceed directly to consolidation
- Consolidation chemotherapy: Patients receive paclitaxel IV over 3 hours and carboplatin
IV over 1 hour every 21 days for 2 courses.
Patients are followed at 6 weeks, every 3 months for 1 year, every 6 months for 2-3 years,
and then annually for 4-5 years.
PROJECTED ACCRUAL: A total of 21-60 patients will be accrued for this study within 20
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Mediastinal nodal sterilization rate
At completion of concurrent chemotherapy and radiation therapy
Mohan Suntharalingam, MD
University of Maryland Greenebaum Cancer Center
United States: Federal Government
|Mayo Clinic - Jacksonville||Jacksonville, Florida 32224|
|Mayo Clinic Cancer Center||Rochester, Minnesota 55905|
|CCOP - Michigan Cancer Research Consortium||Ann Arbor, Michigan 48106|
|Saint Joseph Mercy Cancer Center||Ann Arbor, Michigan 48106-0995|
|Medical College of Wisconsin Cancer Center||Milwaukee, Wisconsin 53226|
|USC/Norris Comprehensive Cancer Center and Hospital||Los Angeles, California 90033-0804|
|Hollings Cancer Center at Medical University of South Carolina||Charleston, South Carolina 29425|
|St. Vincent Hospital Regional Cancer Center||Green Bay, Wisconsin 54307-3508|
|Tallahassee Memorial Hospital||Tallahassee, Florida 32308|
|Greenebaum Cancer Center at University of Maryland Medical Center||Baltimore, Maryland 21201|
|Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis||St. Louis, Missouri 63110|
|Methodist Estabrook Cancer Center||Omaha, Nebraska 68114-4199|
|Cancer Institute of New Jersey at Cooper - Voorhees||Voorhees, New Jersey 08043|
|Christine LaGuardia Phillips Cancer Center at Wellmont Holston Valley Medical Center||Kingsport, Tennessee 37662|
|Leo W. Jenkins Cancer Center at ECU Medical School||Greenville, North Carolina 27834|
|St. Luke's Cancer Network at St. Luke's Hospital||Bethlehem, Pennsylvania 18015|
|Schiffler Cancer Center at Wheeling Hospital||Wheeling, West Virginia 26003|
|Arizona Oncology Services Foundation||Phoenix, Arizona 85013|
|Cancer Institute at St. John's Hospital||Springfield, Illinois 62701|
|Virginia G. Piper Cancer Center at Scottsdale Healthcare - Shea||Scottsdale, Arizona 85260|
|Veterans Affairs Medical Center - Milwaukee||Milwaukee, Wisconsin 53295|
|Cancer Institute of New Jersey at Cooper University Hospital - Camden||Camden, New Jersey 08103|