Combination Chemotherapy, Surgery, and Radiation Therapy in Treating Patients With Non-Small Cell Lung Cancer
RATIONALE: Drugs used in chemotherapy use 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 combination chemotherapy with radiation therapy before and after surgery may shrink the tumor so it can be removed during surgery and may kill any remaining tumor cells following surgery.
PURPOSE: Phase II trial to study the effectiveness of combining paclitaxel and carboplatin with radiation therapy and surgery in treating patients who have newly diagnosed locally advanced non-small cell lung cancer.
Procedure: conventional surgery
Radiation: radiation therapy
|Study Design:||Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Trimodality Protocol for the Treatment of Locally Advanced, Potentially Resectable Non-Small Cell Lung Cancer Targeting|
- Maximum tolerated dose [ Designated as safety issue: Yes ]
|Study Start Date:||July 2002|
|Estimated Study Completion Date:||September 2014|
|Primary Completion Date:||December 2006 (Final data collection date for primary outcome measure)|
- Determine the complete resection rate and toxic death rate of patients with locally advanced non-small cell lung cancer treated with paclitaxel, carboplatin, and radiotherapy followed by surgical resection and adjuvant paclitaxel and carboplatin.
- Determine the survival, event-free survival, and incidence of pathologic complete remission of patients treated with this regimen.
- Determine the protocol completion rate (CR) of patients treated with this regimen.
- Determine the feasibility and toxicity of this regimen in these patients.
- Determine the pathologic response rate/downstaging, pathologic near CR rate, freedom from distant metastasis rate, and freedom from local regional failure rate of patients treated with this regimen.
OUTLINE: Patients receive induction therapy comprising radiotherapy 5 days a week for 5.5-6 weeks and paclitaxel IV over 1 hour and carboplatin IV over 30 minutes on days 1, 8, 15, 22, 29, and 36.
Within 1-3 weeks after completion of induction therapy, patients undergo restaging. Patients with resectable disease undergo surgical resection within 4-8 weeks after induction therapy. Patients with unresectable disease undergo additional radiotherapy 5 days a week for 3 weeks and receive paclitaxel and carboplatin as in induction therapy on days 1, 8, and 15.
Within 4-12 weeks after surgery or additional chemoradiotherapy, patients receive adjuvant therapy comprising paclitaxel and carboplatin as in induction therapy on day 1. Adjuvant treatment repeats every 4 weeks for 3 courses.
Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
PROJECTED ACCRUAL: Approximately 57 patients will be accrued for this study within 4 years.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00043108
|United States, Pennsylvania|
|Fox Chase Cancer Center - Philadelphia|
|Philadelphia, Pennsylvania, United States, 19111-2497|
|Principal Investigator:||Aruna J. Turaka, MD||Fox Chase Cancer Center|