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

niversitair Medisch Centrum Groningen0 个研究点目标入组 600 人开始时间: 待定最近更新: 2024年6月18日

适应症

试验速览

暂无简介。

•- Patients with resectable NSCLC
•- SUVmax >= 10
•- Age >= 18 years
•- 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.

•- 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.
•- 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;

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