Status:
TERMINATED
Study of Docetaxel/Gemcitabine Followed by Chemo-radiotherapy (Chemo-RT), With or Without Consolidation Chemotherapy, in IIIA/IIIB Non Small Cell Lung Cancer (NSCLC)
Lead Sponsor:
Hellenic Oncology Research Group
Collaborating Sponsors:
University Hospital of Crete
Conditions:
Non Small Cell Lung Cancer
Eligibility:
All Genders
19-75 years
Phase:
PHASE2
Brief Summary
The combination of chemotherapy with radiotherapy remains the standard of therapy for patients with stage III NSCLC. A recent phase II study has presented encouraging data regarding the administration...
Detailed Description
To evaluate whether the administration of consolidation therapy with docetaxel/carboplatin after induction chemotherapy followed by concurrent chemoradiotherapy, offers any advantage regarding time to...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2009
Estimated Enrollment :
38 Patients enrolled
Trial Details
Trial ID
NCT00431613
Start Date
March 1 2006
End Date
February 1 2009
Last Update
May 29 2015
Active Locations (10)
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1
University Hospital of Crete
Heraklion, Crete, Greece, 71110
2
University General Hospital of Alexandroupolis, Dep of Medical Oncology
Alexandroupoli, Greece
3
401 Military Hospital, Medical Oncology Unit
Athens, Greece
4
Air Forces Military Hospital, Dep of Medical Oncology
Athens, Greece