Paclitaxel, Carboplatin, and Radiation Therapy in Treating Patients Who Are Undergoing Surgery for Stage III Non-Small Cell Lung Cancer
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.
Procedure: adjuvant therapy
Procedure: conventional surgery
Procedure: neoadjuvant therapy
Radiation: radiation therapy
|Study Design:||Masking: Open Label
Primary Purpose: Treatment
|Official Title:||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|
- Mediastinal nodal sterilization rate [ Designated as safety issue: No ]
- Rate of complete pathological response after treatment [ Designated as safety issue: No ]
- Rate of major morbidities within 30 days of surgery [ Designated as safety issue: Yes ]
- Rate of resectability after chemotherapy [ Designated as safety issue: No ]
- Rates of R0, R1, and R2 resections after chemotherapy [ Designated as safety issue: No ]
- Overall survival [ Designated as safety issue: No ]
- Progression-free survival [ Designated as safety issue: No ]
- Toxicity [ Designated as safety issue: Yes ]
|Study Start Date:||September 2004|
|Primary Completion Date:||April 2012 (Final data collection date for primary outcome measure)|
- 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.
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|Principal Investigator:||Mohan Suntharalingam, MD||University of Maryland Greenebaum Cancer Center|