Sequential Administration of Docetaxel/Gemcitabine Followed by Concurrent Chemo-radiotherapy, With or Without Consolidation Chemotherapy, as First Line Treatment in Patients With Unresectable Stage IIIA/IIIB NSCLC. A Randomized Phase II Study
19 Years
75 Years
Both
Non Small Cell Lung Cancer
Trial Information
Sequential Administration of Docetaxel/Gemcitabine Followed by Concurrent Chemo-radiotherapy, With or Without Consolidation Chemotherapy, as First Line Treatment in Patients With Unresectable Stage IIIA/IIIB NSCLC. A Randomized Phase II Study
To evaluate whether the administration of consolidation therapy with docetaxel/carboplatin
after induction chemotherapy followed by concurrent chemoradiotherapy, offers any advantage
regarding time to tumor progression
Inclusion Criteria:
- histologically or cytologically confirmed, unresectable locally advanced (stage
IIIA/IIIB) NSCLC
- 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:
- active infection
- 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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Time to tumor progression (TTP)
Outcome Time Frame:
1 year
Safety Issue:
No
Principal Investigator
Vassilis Georgoulias, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
University Hospital of Crete
Authority:
Greece: National Organization of Medicines
Study ID:
CT/04.26
NCT ID:
NCT00431613
Start Date:
March 2006
Completion Date:
February 2009
Related Keywords:
- Non Small Cell Lung Cancer
- NSCLC
- Induction chemotherapy
- Concurrent chemoradiotherapy
- Consolidation therapy
- Docetaxel
- Gemcitabine
- Carboplatin
- Carcinoma, Non-Small-Cell Lung
- Lung Neoplasms
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