A randomized phase III study of adjuvant chemotherapy with or without low-molecular weight heparin in patients with high risk for recurrence and completely resected non-small-cell lung cancer: NVALT-8B - NVALT-8B

MCG0 sitesStarted: July 6, 2009Last updated: March 19, 2012

Conditions

Drugs

Trial Snapshot

No summary available.

•- Patients with NSCLC, pT2N0, pT1N1, pT2N1, pT3N0 and pT3N1
•- SUVmax ? 7
•- Age = 18 years
•- Patients with NSCLC who had a surgical R0 resection.
•- WHO Performance score = 2 before chemotherapy.
•- Adequate organ function before administration of chemotherapy, including: Adequate bone marrow reserve: ANC > 1.5 x 109/L, platelets > 100 x 109/L.
•Hepatic: bilirubin < 1.5 x ULN, AP, ALT, AST < 3.0 x ULN.
•Renal: calculated creatinine clearance > 60 ml/min based on the Cockroft and Gault formula.
•INR < 1.5
•- Patients must sign and date a written Independent Ethics Committee approved informed consent form.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

•- Patients with incomplete or inadequate pulmonary resections. incomplete preoperative or intraoperative staging, wedge or segmental resection.
•- Prior chemotherapy or radical radiotherapy.
•- 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.
•- Inability to interrupt aspirin or other nonsteroidal anti-inflammatory agents for a 5-day period (8 day period for long-acting agents such as piroxicam).
•- Inability or unwillingness to take folic acid, vitamin B-12 supplementation or dexamethasone.
•- 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
•- Men and women of child-bearing potential not using effective means of contraception for 6 months after treatment has been completed
•- Indication for anticoagulant treatment.
•- Any contraindication listed in the labeling of nadroparin.
•- Documented history of heparin-induced thrombocytopenia with UFH or LMWH
•- Current active bleeding or judged to be as high risk of bleeding.

Sponsor

MCG