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.
- Conditions
- lung cancerNon-small cell lung cancer10038666
- Registration Number
- NL-OMON35584
- Lead Sponsor
- niversitair Medisch Centrum Groningen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 600
- 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;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The main endpoint is recurrence-free survival. </p><br>
- Secondary Outcome Measures
Name Time Method <p>Secundary end-points are overall survival, dose intensity of subsequent cycles,<br /><br>quality of life, toxicity, health economics. Exploratory endpoints are analysis<br /><br>of blood and tumor samples for prognostic markers, genomics/proteomics.</p><br>