Lungcancer non-small cell lung cancer
Conditions
Interventions
None listed
Sponsors
European Organisation for Research in Treatment of Cancer (EORTC)
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: * Age >= 18 years * WHO performance status 0-1 * Histologically or cytological confirmed clinical stage II-IIIA non-small cell lung carcinoma (NSCLC), according to 7th TNM classification (NOTE: patients with resectable N2 disease are also eligible) * Baseline standard imaging assessment & staging should be performed within 6 weeks prior to planned treatment start. * Patients must be candidate for curative intent surgery, and must be expected to complete the treatment. * No prior or current anticancer treatment for NSCLC, pre-operative therapy will include only chemotherapeutic drugs (pemetrexed is contraindicated), no other biological, targeted or radiotherapy is allowed * No treatment with any investigational drug substance within 4 weeks prior to registration. * No other malignancies in the 3 years prior to study entry with the exception of surgically cured carcinoma in situ of the cervix, in situ breast cancer, incidental finding of stage T1a or T1b prostate cancer, and basal/squamous cell carcinoma of the skin * No evidence of any medical condition which would impair the ability of the patient to participate in the trial or might preclude therapy with chemotherapeutic drugs according to routine medical practice (e.g. unstable or uncompensated respiratory, cardiac, hepatic or renal disease, known dihydropyrimidine dehydrogenase deficiency, active infection, uncontrolled diabetes mellitus; uncontrolled arterial hypertension, history of unstable myocardial infarction) * Adequate hematology and biochemical investigations, (should be done maximum 6 weeks before treatment starts) * Normal bone marrow function based on routine blood samples, i.e. neutrophils >= 1.5 x 109/L, platelets >= 75 x 109/L, hemoglobin >= 10.0 g/dL * Normal kidney function creatinine clearance >= 60 mL/min, * Normal liver function assessed by routine laboratory examinations, i.e. bilirubin
Exclusion criteria
Exclusion criteria: - Does not meet the inclusion criteria - Younger than 50 years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| * Percentage of ADC change at day 14 (i.e. ADC-2) relative to baseline (i.e. ADC-1) * Percentage of FLT uptake change at day 14 (i.e. SUV-2) relative to baseline (i.e. SUV-1) * Pathological quantification (% viable tumor cells) measured in surgical specimens | — |
Secondary
| Measure | Time frame |
|---|---|
| * Pre-operative (post-treatment) ADC measurement (i.e. ADC-3) * Pre-operative (post-treatment) FLT uptake measurement (i.e. SUV-3) * Tumor volume (baseline and pre-operative) measured by CT or MRI * Immunohistochemistry (IHC) of cell proliferation marker Ki-67-index in diagnostic biopsy samples (if available) and surgical specimens. * Metabolic change in FDG-PET (baseline and pre-operative, if available) * Safety | — |
Countries
Netherlands
Outcome results
None listed