Overview

Study of Docetaxel/Gemcitabine Followed by Chemo-radiotherapy (Chemo-RT), With or Without Consolidation Chemotherapy, in IIIA/IIIB Non Small Cell Lung Cancer (NSCLC)

Status:
Terminated
Trial end date:
2009-02-01
Target enrollment:
0
Participant gender:
All
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 of docetaxel as consolidation treatment after definitive concurrent chemo-radiotherapy.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Hellenic Oncology Research Group
Collaborator:
University Hospital of Crete
Treatments:
Carboplatin
Docetaxel
Gemcitabine
Criteria
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