non-small-cell lung cancer
Conditions
Interventions
Patients will be randomised to observational 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
Sponsors
NVALT oncology
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age >= 18 years 2. Patients with NSCLC, pT2N0, pT1N1, pT2N1, pT3N0 and pT3N1 3. SUVmax 1.5 x 109/L, Platelets > 100 x 109/L. - Hepatic: bilirubin 60 ml/min based on the Cockroft and Gault formula. 7. Patients must sign and date an approved Informed Consent form.
Exclusion criteria
Exclusion criteria: 1. Patients with incomplete or inadequate pulmonary resections. incomplete preoperative or intraoperative staging, wedge or segmental resection. 2. Prior chemotherapy or radical radiotherapy. 3. 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). 4. Concomitant treatment with any other experimental drug under investigation. 5. 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. 6. Pregnancy 7. Women of child-bearing potential not using effective means of contraception
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The main endpoint is recurrence-free survival. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secundary 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. | — |
Contacts
Public ContactD. Storm
The Netherlands Cancer center NVALT Trial Desk Plesmanlaan 121
Outcome results
None listed