Phase II Docetaxel / Carboplatin / XRT + Surgical Resection in Stage III NSCLC
The purpose of this study is to assess how well this particular combination of chemotherapy, radiation and surgery works to help people with locally advanced lung cancer, how well PET scans indicates whether someone has responded to chemotherapy and radiation, and gene expression patterns related to outcomes in patients with locally advanced lung cancer who receive this treatment regimen.
Carcinoma, Non-Small-Cell Lung
Procedure: Radiation therapy
Procedure: Surgical resection
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Trial of Concurrent Docetaxel (Taxotere) / Carboplatin / Radiotherapy Followed by Surgical Resection Followed by Consolidation Taxotere / Carboplatin in Stage III Non-Small Cell Lung Cancer (NSCLC)|
- 2 Year Overall Survival After a Combination of Chemotherapy, Radiation and Surgery in Stage III NSCLC Patients Following the Protocol Therapy. [ Time Frame: Two years ] [ Designated as safety issue: Yes ]Patients were analyzed for 2 year overall survival after receiving trimodality (chemotherapy/radiation/surgery) therapy for stage III NSCLC. Patients had a chest x-ray and a doctor visit with a physical examination every 3 months after completion of all therapy for 3 years then every 6 months for 3 years to look for evidence of recurrent disease and to follow survival. Thoracic computed tomography (CT) scans were obtained at 6, 12, 18 months after completion of all therapy and then yearly for 3 years or as clinically indicated to evaluate for relapse.
- Change in Standard Uptake Value (SUVmax) on Positron Emission Tomography (PET) Scans Pre and Post Chemotherapy and Radiation in This Trial and Ability to Predict Surgical Resection Rate, Progression-free Survival and 2 Year Overall Survival [ Time Frame: baseline, 5 weeks after combined chemo-radiation ] [ Designated as safety issue: No ]The change in standardized uptake values (SUV)max on PET scans obtained pre- and after 5 weeks of combined chemo-radiation for patients enrolled on the trial were evaluated for ability to predict outcomes including complete resection at time of surgery (3-6 weeks after completion of the chemo-radiation), progression-free survival and 2 year overall survival. The mean SUVmax pre chemoradiation minus the mean SUVmax post-radiation is reported.
- Exploratory Analysis of Relation of Gene Expression Patterns to Outcomes in Patients With Locally Advanced Lung Cancer Who Receive This Treatment Regimen [ Time Frame: Specimen collected at time of surgery ] [ Designated as safety issue: No ]This analysis of gene expression patterns related to outcomes in patients with locally advanced lung cancer who received this treatment regimen was not performed due to lack of funding.
|Study Start Date:||March 2003|
|Study Completion Date:||November 2014|
|Primary Completion Date:||September 2009 (Final data collection date for primary outcome measure)|
20 mg/m2, 75 mg/m2 infusion
Other Name: TaxotereDrug: Carboplatin
AUC of 2 and 6 infusion
Other Name: ParaplatinProcedure: Radiation therapy
NEOADJUVANT RADIOTHERAPY Radiation therapy will be concurrent with the chemotherapy. Radiation therapy will begin within 24 hours of chemotherapy. CONSOLIDATION RADIOTHERAPY Patients with positive surgical margins or incomplete resection (tumor shaved from spine or great vessels) will receive an additional boost of radiotherapy 3 to 6 weeks after surgery. This will be a 16 Gy boost given with concurrent weekly chemotherapy as during the neoadjuvant period.
Other Names:Procedure: Surgical resection
All patients will be taken to surgical excision, unless they have developed a condition other than progressive disease, which would make surgery unsafe.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00238615
|United States, California|
|Stanford University School of Medicine|
|Stanford, California, United States, 94305|
|Principal Investigator:||Heather A. Wakelee||Stanford University|