A randomized phase III study of adjuvant chemotherapy in patients with completely resected Non-Small-Cell Lung Cancer and low-risk for recurrence: NVALT-8A - NVALT-8A
- Conditions
- This is a randomized multicenter phase III study. Patient with a low SUV of the primary tumor prior to surgery will be randomised to four cycles of cisplatin-based chemotherapy or observation in a non-inferiority design.
- Registration Number
- EUCTR2007-002644-21-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
- Age = 18 years
-Patients with NSCLC, pT2N0, pT1N1, pT2N1, pT3N0 and pT3N1
-SUVmax < 7
-Patients with NSCLC who had a surgical R0 resection.
-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.
-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.
-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
-Women of child-bearing potential not using effective means of contraception
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 it is possible to select patients by PET in a good prognosis group (i.e. low SUV) who will not benefit from adjuvant chemotherapy.;Secondary Objective: 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.;Primary end point(s): The main endpoint is recurrence-free survival.
- Secondary Outcome Measures
Name Time Method