Study of Docetaxel/Gemcitabine Followed by Chemo-radiotherapy (Chemo-RT), With or Without Consolidation Chemotherapy, in IIIA/IIIB Non Small Cell Lung Cancer (NSCLC)
NCT ID: NCT00431613
Last Updated: 2015-05-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2
38 participants
INTERVENTIONAL
2006-03-31
2009-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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1
DG -\> RT
Docetaxel
Docetaxel 75 mg/m2 IV on day 8 every 3 weeks for 2 cycles
Gemcitabine
Gemcitabine 1100 mg/m2 on days 1 and 8 every 3 weeks for 2 cycles
Chemoradiotherapy
After 21 days from the 2nd chemotherapy cycle definitive concurrent chemoradiotherapy will be started: daily fractions of 1.8 Gy for 5 days/week, for a total dose of 45 Gy.
During the radiotherapy docetaxel 25 mg/m2, IV, will be administered on days 1, 8, 15, 22, 29 and carboplatin 2AUC, IV , on days 4, 11, 18, 25, 32
2
DG -\> RT -\> DCarbo
Docetaxel
Docetaxel 75 mg/m2 IV on day 8 every 3 weeks for 2 cycles
Gemcitabine
Gemcitabine 1100 mg/m2 on days 1 and 8 every 3 weeks for 2 cycles
Carboplatin
Carboplatin 6AUC IV on day 1 every 3 weeks for 3 cycles
Chemoradiotherapy
After 21 days from the 2nd chemotherapy cycle definitive concurrent chemoradiotherapy will be started: daily fractions of 1.8 Gy for 5 days/week, for a total dose of 45 Gy.
During the radiotherapy docetaxel 25 mg/m2, IV, will be administered on days 1, 8, 15, 22, 29 and carboplatin 2AUC, IV , on days 4, 11, 18, 25, 32
Docetaxel
Docetaxel 75mg/m2 IV on day 1 for 3 cycles
Interventions
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Docetaxel
Docetaxel 75 mg/m2 IV on day 8 every 3 weeks for 2 cycles
Gemcitabine
Gemcitabine 1100 mg/m2 on days 1 and 8 every 3 weeks for 2 cycles
Carboplatin
Carboplatin 6AUC IV on day 1 every 3 weeks for 3 cycles
Chemoradiotherapy
After 21 days from the 2nd chemotherapy cycle definitive concurrent chemoradiotherapy will be started: daily fractions of 1.8 Gy for 5 days/week, for a total dose of 45 Gy.
During the radiotherapy docetaxel 25 mg/m2, IV, will be administered on days 1, 8, 15, 22, 29 and carboplatin 2AUC, IV , on days 4, 11, 18, 25, 32
Docetaxel
Docetaxel 75mg/m2 IV on day 1 for 3 cycles
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* no previous therapy for NSCLC is allowed
* age \>18 years
* bidimensionally measurable disease
* performance status (WHO) 0-2
* absence of pleural effusion
* adequate liver (serum bilirubin \< 1.5 times the upper normal limit (UNL); AST and ALT \< 2.5 times the UNL in the absence of demonstrable liver metastases, or \< 5 times the UNL in the presence of liver metastases); adequate renal function (serum creatinine \< 1.5 times the UNL); and bone marrow (neutrophils ≥ 1.5x 109 /L, and platelets ≥ 100x 109 /L) function
* life expectancy of more than 3 months
* written informed consent
Exclusion Criteria
* history of significant cardiac disease (unstable angina, congestive heart failure, myocardial infarction within the previous 6 months, ventricular arrhythmias)
* malnutrition (loss of ≥ 20% of the original body weight)
* performance status: 3-4
* sensor or motor neuropathy \> grade I
* second primary malignancy, except for non-melanoma skin cancer
* psychiatric illness or social situation that would preclude study compliance
* pregnant or lactating women
19 Years
75 Years
ALL
No
Sponsors
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University Hospital of Crete
OTHER
Hellenic Oncology Research Group
OTHER
Responsible Party
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Principal Investigators
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Vassilis Georgoulias, MD
Role: PRINCIPAL_INVESTIGATOR
University Hospital of Crete
Locations
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University Hospital of Crete
Heraklion, Crete, Greece
University General Hospital of Alexandroupolis, Dep of Medical Oncology
Alexandroupoli, , Greece
401 Military Hospital, Medical Oncology Unit
Athens, , Greece
Air Forces Military Hospital, Dep of Medical Oncology
Athens, , Greece
IASO General Hospital of Athens, 1st Dep of Medical Oncology
Athens, , Greece
Laikon General Hospital, Medical Oncology Unit, Propedeutic Dep of Internal Medicine
Athens, , Greece
Sismanogleio General Hospital, 1st, 2nd Dep of Pulmonary Diseases
Athens, , Greece
Sotiria General Hospital, 1st, 3rd, 6th, 7th, 8th Dep of Pulmonary Diseases
Athens, , Greece
Metaxa's Anticancer Hospital of Piraeus,1st Dep of Medical Oncology
Piraeus, , Greece
Theagenion Anticancer Hospital of Thessaloniki
Thessaloniki, , Greece
Countries
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Other Identifiers
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CT/04.26
Identifier Type: -
Identifier Source: org_study_id
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