Paclitaxel, Carboplatin, and Radiation Therapy in Treating Patients Who Are Undergoing Surgery for Stage III Non-Small Cell Lung Cancer
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|ClinicalTrials.gov Identifier: NCT00096226|
Recruitment Status : Completed
First Posted : November 9, 2004
Results First Posted : February 27, 2014
Last Update Posted : November 17, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|Lung Cancer||Drug: Induction Carboplatin Drug: Induction Paclitaxel Procedure: Resection Drug: Consolidation Carboplatin Radiation: Radiation Therapy Drug: Consolidation Paclitaxel||Phase 2|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||60 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||September 2004|
|Actual Primary Completion Date :||April 2012|
Experimental: Chemoradiation, Surgery, Chemotherapy
Induction paclitaxel(50 mg/m2 I.V. in a one-hour infusion) and induction carboplatin (AUC 2.0 I.V. in a thirty-minute infusion): 1x/week for 6 weeks. Concurrent radiation therapy (RT): 1.8 Gy/day, 5 fx/week, for a total of 50.4 Gy in 28 fractions plus a boost of 1.8 Gy/day, 5 fx/week, for a total of 10.8 Gy in 6 fractions. Followed by an assessment to determine whether patient will undergo a resection or not. Followed by consolidation paclitaxel (200 mg/m2 I.V. over three hours) and consolidation carboplatin (AUC 6.0 over one hour) q 21 days x 2.
|Drug: Induction Carboplatin Drug: Induction Paclitaxel Procedure: Resection Drug: Consolidation Carboplatin Radiation: Radiation Therapy Drug: Consolidation Paclitaxel|
- Mediastinal Nodal Clearance Rate [ Time Frame: At completion of concurrent chemotherapy and radiation therapy, up to 14 weeks. ]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.
- Rate of Complete Pathological Response After Concurrent Chemotherapy and Radiation Therapy [ Time Frame: At completion of concurrent chemotherapy and radiation therapy ]
- Rate of Major Morbidities Within 30 Days of Surgery [ Time Frame: From date of surgery to 30 days following the date of surgery ]
- Rate of Resectability After Chemotherapy [ Time Frame: At completion of concurrent chemotherapy and radiation therapy ]
- Rates of R0, R1, and R2 Resections After Chemotherapy [ Time Frame: At completion of concurrent chemotherapy and radiation therapy ]
- Overall Survival [ Time Frame: From registration to two years ]
- Progression-free Survival [ Time Frame: From registration to two years ]
- Toxicity [ Time Frame: From start of treatment to end of follow-up ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00096226
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|Principal Investigator:||Mohan Suntharalingam, MD||University of Maryland Greenebaum Cancer Center|