Phase II Docetaxel / Carboplatin / XRT + Surgical Resection in Stage III NSCLC
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|ClinicalTrials.gov Identifier: NCT00238615|
Recruitment Status : Terminated (low accrual)
First Posted : October 13, 2005
Results First Posted : July 4, 2013
Last Update Posted : May 12, 2015
|Condition or disease||Intervention/treatment||Phase|
|Lung Cancer Carcinoma, Non-Small-Cell Lung||Drug: Docetaxel Drug: Carboplatin Procedure: Radiation therapy Procedure: Surgical resection||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||13 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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)|
|Study Start Date :||March 2003|
|Actual Primary Completion Date :||September 2009|
|Actual Study Completion Date :||November 2014|
20 mg/m2, 75 mg/m2 infusion
Other Name: Taxotere
AUC of 2 and 6 infusion
Other Name: Paraplatin
Procedure: 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.
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.
- 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 ]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 ]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 ]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.
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): NCT00238615
|United States, California|
|Stanford University School of Medicine|
|Stanford, California, United States, 94305|
|Principal Investigator:||Heather A. Wakelee||Stanford University|