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
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.
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
chemotherapy.
- 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
months.
Interventional
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Mediastinal nodal sterilization rate
At completion of concurrent chemotherapy and radiation therapy
No
Mohan Suntharalingam, MD
Principal Investigator
University of Maryland Greenebaum Cancer Center
United States: Federal Government
RTOG-0229
NCT00096226
September 2004
Name | Location |
---|---|
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 |