Cisplatin/Etoposide/Radiotherapy +/- Consolidation Docetaxel in Advanced Stage III Non-Small Cell Lung Cancer
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|ClinicalTrials.gov Identifier: NCT00216125|
Recruitment Status : Completed
First Posted : September 22, 2005
Results First Posted : February 8, 2016
Last Update Posted : March 16, 2016
In a previous phase II study, patients with pathological stage IIIb (without pleural effusion) NSCLC were treated with concurrent cisplatin and etoposide plus thoracic radiotherapy followed by 3 cycles of consolidation therapy with docetaxel. Docetaxel was selected based upon a survival benefit in patients with recurrent NSCLC.
This trial will evaluate the role of consolidation therapy with docetaxel in patients with unresectable stage III disease. The purpose of the trial is to evaluate survival and toxicities of the regimens employed.
|Condition or disease||Intervention/treatment||Phase|
|Non-Small Cell Lung Cancer||Drug: Cisplatin Drug: Etoposide Radiation: Radiation Drug: Docetaxel||Phase 3|
OUTLINE: This is a multi-center study.
- Cisplatin 50 mg/m2 d1, 8, 29, 36
- Etoposide 50 mg/m2/day d1-5, 29-33
- Radiation 5940 cGy (180 cGy/day)
Patients with CR, PR, SD Randomized to either:Docetaxel75 mg/m2 q3wk X 3 cycles
or Observation Only
Performance Status: ECOG 0 or 1
Life Expectancy: Not specified
- ANC > 1,500/mm3
- Platelet count > 100,000/mm3
- Hemoglobin > 8 g/dl. PRBC transfusions will be allowed to increase hemoglobin to >8 g/dl
- Serum bilirubin < institutional upper limit of normal (ULN)
- AST < 2.5 X the upper limits of normal if alkaline phosphatase is < ULN, or alkaline phosphatase may be up to 4 X ULN if AST are < ULN
- Serum creatinine of < 2 mg/dl or calculated creatinine clearance > 50 cc/min
- No clinically significant history of cardiac disease, (i.e. uncontrolled hypertension, unstable angina, congestive heart failure, myocardial infarction within the past year, or cardiac ventricular arrhythmias requiring medication).
- Pre-registration FEV1 > 1 liters by spirometry within 42 days prior to study treatment.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||243 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||A Phase III Trial of Cisplatin/Etoposide/Radiotherapy With or Without Consolidation Docetaxel in Patients With Inoperable Locally Advanced Stage III Non-Small Cell Lung Cancer (NSCLC): Hoosier Oncology Group LUN01-24|
|Study Start Date :||February 2002|
|Actual Primary Completion Date :||June 2006|
|Actual Study Completion Date :||March 2008|
Prior to randomization patients received Cisplatin 50 mg/m^2 days 1,8,29,36 + Etoposide 50 mg/m^2 days 1-5, 29-33 + Radiation 5940 cGy (180 cGy/day). Patients with CR, PR or SD with manageable toxicity were randomized to either Docetaxel arm or Observation only arm.
Cisplatin 50 mg/m2 day 1, 8, 29, 36
Other Name: Platinol
Etoposide 50 mg/m2, days 1-5, 29-33
Other Name: VP-16
Radiation 5940 cGy (180 cGy/day)
Active Comparator: Consolidation Docetaxel
Docetaxel 75 mg/m^2 q3wk X 3 cycles.
docetaxel 75mg/m2 q3wk x 3 cycles
Other Name: Taxol
No Intervention: Observation Only
Patients were followed for Observation.
- Overall Survival [ Time Frame: Participants were measured from treatment initiation to death ]A comparison of overall survival following cisplatin/etoposide/radiotherapy between the consolidation docetaxel and observation arms was analyzed using Kaplan-Meier analysis. Median survival time and a log rank test were used to analyze the hypothesized improvement in overall survival.
- Progression Free Survival [ Time Frame: Participants were monitored from treatment initiation until disease progression per RECIST or death ]
A comparison of progression free survival following cisplatin/etoposide/radiotherapy between the consolidation docetaxel and observation arms was analyzed using Kaplan-Meier analysis. Median PFS time and a log rank test were used to analyze the hypothesized improvement in progression free survival.
Progression is defined by RECIST as a 20% increase in the sum of longest diameters of target measurable lesions over the smallest sum observed (over baseline if no decrease during therapy) or by the appearance of a new lesion.
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): NCT00216125
|United States, Illinois|
|Medical & Surgical Specialists, LLC|
|Galesburg, Illinois, United States, 61401|
|United States, Indiana|
|Elkhart, Indiana, United States, 46515|
|Oncology Hematology Associates of SW Indiana|
|Evansville, Indiana, United States, 47714|
|Fort Wayne Oncology & Hematology, Inc|
|Fort Wayne, Indiana, United States, 46815|
|Center for Cancer Care at Goshen Health System|
|Goshen, Indiana, United States, 46527|
|Indiana University Cancer Center|
|Indianapolis, Indiana, United States, 46202|
|Quality Cancer Center (MCGOP)|
|Indianapolis, Indiana, United States, 46202|
|Community Regional Cancer Center|
|Indianapolis, Indiana, United States, 46256|
|Medical Consultants, P.C.|
|Muncie, Indiana, United States, 47303|
|Center for Cancer Care, Inc., P.C.|
|New Albany, Indiana, United States, 47150|
|Northern Indiana Cancer Research Consortium|
|South Bend, Indiana, United States, 46601|
|Terre Haute, Indiana, United States, 47804|
|United States, Missouri|
|Siteman Cancer Center|
|St. Louis, Missouri, United States, 63110|
|United States, Nebraska|
|Methodist Cancer Center|
|Omaha, Nebraska, United States, 68114|
|United States, Texas|
|Houston, Texas, United States, 77060|
|Study Chair:||Nasser Hanna, M.D.||Hoosier Oncology Group, LLC|