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