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
- Conditions
- This is a randomized multicenter phase III study. Patient with a high SUVof the primary tumor prior to surgery will be randomised to four cycles of pemetrexed and cisplatin with or without nadroparin for 16 weeks in order to improve the recurrence-free survival rate in these patients.
- Registration Number
- EUCTR2007-002608-16-NL
- Lead Sponsor
- MCG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
- 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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The primary aim of the study is to investigate whether adding Nadroparin to adjuvant chemotherapy in patients in the poor prognostic group (i.e. high SUV) prolongs recurrence-free survival;Secondary Objective: 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.;Primary end point(s): The main endpoint is recurrence-free survival
- Secondary Outcome Measures
Name Time Method