lungcancer Non-smal cell lung cancer
Conditions
Interventions
Patients will be randomized to observation or will be treated with 4 cycles of
one of the four cisplatin-based chemotherapy regimens:
-Docetaxel (75 mg/m2 day 1) and cisplatin (75 mg/m2 day 1) Q 3 we
Sponsors
Universitair Medisch Centrum Groningen
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Age >= 18 years - Patients with resectable NSCLC - SUVmax = 1.5 x 109/L, platelets >= 100 x 109/L. Hepatic: bilirubin = 60 ml/min based on the Cockroft and Gault formula. - Patients must sign and date a written Independent Ethics Committee approved informed consent form.
Exclusion criteria
Exclusion criteria: - Patients with wedge or segmental resection. - Patients with stage IA NSCLC - Prior chemotherapy or radical radiotherapy for NSCLC. - Any unstable systemic disease (including active infection, uncontrolled hypertension, unstable angina, congestive heart failure, myocardial infarction within the previous year, severe cardiac arrhythmia requiring medication, hepatic, renal or metabolic disease). - Concomitant treatment with any other experimental drug under investigation. - History of any active malignancy (other than NSCLC) unless treated more than 3 years with curative intent and no recurrence, except non-melanoma skin cancer or in situ cervical cancer. - Pregnancy - Women of child-bearing potential not using effective means of contraception
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Recurrence-free survival. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end-points are overall survival, dose intensity of subsequent cycles, quality of life, toxicity, health economics. Exploratory endpoints are analysis of blood and tumor samples for prognostic markers, genomics/proteomics. | — |
Countries
Netherlands
Outcome results
None listed