Cisplatin/Etoposide/Radiotherapy +/- Consolidation Docetaxel in Advanced Stage III Non-Small Cell Lung Cancer
NCT ID: NCT00216125
Last Updated: 2016-03-16
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
243 participants
INTERVENTIONAL
2002-02-28
2008-03-31
Brief Summary
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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.
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Detailed Description
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* 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
Hematopoietic:
* 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
Hepatic:
* 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
Renal:
* Serum creatinine of \< 2 mg/dl or calculated creatinine clearance \> 50 cc/min
Cardiovascular:
* 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).
Pulmonary:
* Pre-registration FEV1 \> 1 liters by spirometry within 42 days prior to study treatment.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Pre-Randomization
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
Cisplatin 50 mg/m2 day 1, 8, 29, 36
Etoposide
Etoposide 50 mg/m2, days 1-5, 29-33
Radiation
Radiation 5940 cGy (180 cGy/day)
Consolidation Docetaxel
Docetaxel 75 mg/m\^2 q3wk X 3 cycles.
Docetaxel
docetaxel 75mg/m2 q3wk x 3 cycles
Observation Only
Patients were followed for Observation.
No interventions assigned to this group
Interventions
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Cisplatin
Cisplatin 50 mg/m2 day 1, 8, 29, 36
Etoposide
Etoposide 50 mg/m2, days 1-5, 29-33
Radiation
Radiation 5940 cGy (180 cGy/day)
Docetaxel
docetaxel 75mg/m2 q3wk x 3 cycles
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Unresectable Stage IIIA will be defined by the following criteria:
* N2 mediastinal lymph nodes must be multiple and/or bulky on CT scan such that in the opinion of the treating investigator, the patient is not a candidate for surgical resection
* N2 disease must be documented by biopsy, FDG-PET scan imaging, or by CT if nodes are \> 2 cm on CT scan
* Stage IIIb patients must have N3 or T4 status. N3 status must be documented by one of the following criteria:
* Contralateral (to the primary tumor) mediastinal lymph node, supraclavicular or scalene lymph nodes proven by biopsy, FDG-PET scan imaging, or by CT if nodes are \> 2 cm on CT scan.
* Patients with positive supraclavicular or scalene lymph nodes must not have disease extending up into the cervical region.
* All patients must have measurable or evaluable disease documented by CT, MRI, X-ray or physical exam within 28 days prior to study treatment.
* Negative pregnancy test
Eligibility for Consolidation Therapy
* Following completion of induction chemoradiotherapy patients without local progression of disease or distant metastases will then be randomized to receive consolidation therapy with docetaxel or observation. Patients will be stratified and randomized based on stage IIIa vs IIIb disease at baseline, CR vs. non-CR following induction chemoradiation, and ECOG PS 0 or 1 vs. 2.
* Patients must have completed chemoradiotherapy per protocol and at least 4 weeks but no more than 8 weeks must have elapsed from the last day of induction therapy (the last day of radiation) to be eligible for randomization to consolidation with docetaxel or observation.
* Patients must have undergone re-staging tests according to the study calendar and determined to have no evidence of disease progression to be eligible for randomization to consolidation with docetaxel or observation.
* Patients must have an ANC \> 1,500/mm3, platelet count \> 100,000/ mm3, and hemoglobin \> 8 g/dl obtained within 14 days prior to registration for randomization to consolidation with docetaxel or observation.
* Patients must have adequate hepatic function as defined by a serum bilirubin \< institutional upper limit of normal (ULN) and an AST and/or ALT \< 2.5 X the upper limits of normal if alkaline phosphatase is \< ULN, or alkaline phosphatase may be up to 4 X ULN if transaminases are \< ULN within 14 days prior to registration for randomization to consolidation with docetaxel or observation.
Exclusion Criteria
* No unintended weight loss \> 5% body weight in the preceding 3 months prior to study treatment will not be eligible for this trial.
* No symptomatic peripheral neuropathy prior to entry onto the study. Peripheral neuropathy must be \< Grade 1 to be eligible.
* No prior malignancy except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer for which the patient has been disease-free for 5 years.
* No history of allergic reactions to drugs utilizing the vehicle polysorbate 80 (docetaxel) and polysorbate 80 + polyethylene glycol (etoposide).
* If the patient has hearing loss at pre-study, performance of an audiogram is recommended (not mandatory) to document baseline hearing status in the event of possible further hearing loss due to cisplatin administration.
* No current breastfeeding
18 Years
ALL
No
Sponsors
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Sanofi
INDUSTRY
Walther Cancer Institute
OTHER
Nasser Hanna, M.D.
OTHER
Responsible Party
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Nasser Hanna, M.D.
Sponsor-Investigator
Principal Investigators
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Nasser Hanna, M.D.
Role: STUDY_CHAIR
Hoosier Oncology Group, LLC
Locations
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Medical & Surgical Specialists, LLC
Galesburg, Illinois, United States
Elkhart Clinic
Elkhart, Indiana, United States
Oncology Hematology Associates of SW Indiana
Evansville, Indiana, United States
Fort Wayne Oncology & Hematology, Inc
Fort Wayne, Indiana, United States
Center for Cancer Care at Goshen Health System
Goshen, Indiana, United States
Indiana University Cancer Center
Indianapolis, Indiana, United States
Quality Cancer Center (MCGOP)
Indianapolis, Indiana, United States
Community Regional Cancer Center
Indianapolis, Indiana, United States
Medical Consultants, P.C.
Muncie, Indiana, United States
Center for Cancer Care, Inc., P.C.
New Albany, Indiana, United States
Northern Indiana Cancer Research Consortium
South Bend, Indiana, United States
AP&S Clinic
Terre Haute, Indiana, United States
Siteman Cancer Center
St Louis, Missouri, United States
Methodist Cancer Center
Omaha, Nebraska, United States
US Oncology
Houston, Texas, United States
Countries
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References
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Hanna N, Neubauer M, Yiannoutsos C, McGarry R, Arseneau J, Ansari R, Reynolds C, Govindan R, Melnyk A, Fisher W, Richards D, Bruetman D, Anderson T, Chowhan N, Nattam S, Mantravadi P, Johnson C, Breen T, White A, Einhorn L; Hoosier Oncology Group; US Oncology. Phase III study of cisplatin, etoposide, and concurrent chest radiation with or without consolidation docetaxel in patients with inoperable stage III non-small-cell lung cancer: the Hoosier Oncology Group and U.S. Oncology. J Clin Oncol. 2008 Dec 10;26(35):5755-60. doi: 10.1200/JCO.2008.17.7840. Epub 2008 Nov 10.
Related Links
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Hoosier Oncology Group Home Page
Other Identifiers
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HOG LUN01-24
Identifier Type: -
Identifier Source: org_study_id
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