Non-small Cell Lung Carcinoma Clinical Trial
— EVIDENCEOfficial title:
Evaluation of 3'-Deoxy-3'-[18F]Fluorothymidine -PET and Diffusion Weighted Imaging -MRI in Patients With Early Stage Non-small Cell Lung Cancer Treated With a Platinum-based Doublet as Preoperative Chemotherapy
The purpose of the study is to qualify, independently, tumor cell proliferation by 3'-Deoxy-3'-[18F]Fluorothymidine (FLT) -Positron Emission Tomography , and cell death by Diffusion Weighted Imaging (DWI) -Magnetic Resonance Imaging (MRI) compared to pathological quantification (% of viable tumor cells) of the primary tumor after pre-operative chemotherapy in patients with operable Non Small Cell Lung Cancer (NSCLC).
Status | Recruiting |
Enrollment | 31 |
Est. completion date | February 2017 |
Est. primary completion date | December 2016 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Age = 18 years - WHO performance status 0-1 (Appendix C) - Histologically or cytological confirmed clinical stage II-IIIA non-small cell lung carcinoma (NSCLC), according to 7th TNM classification (Appendix D) (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. ?? 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 < 1.5 x upper limit of normal (ULN), ALT< 3 x ULN - Patients must not have any contraindication for 18F-FLT-PET/CT or MRI procedures. - Patient primary lung tumor larger than 20 mm in diameter (measured by diagnostic CT or MRI). - Women of child bearing potential (WOCBP) must have a negative serum (or urine) pregnancy test before trial registration. - Patients of childbearing / reproductive potential should use adequate birth control measures, as defined by the investigator, during the study treatment period and for at least 6 months after the last study procedure. A highly effective method of birth control is defined as those which result in low failure rate (i.e. less than 1% per year) when used consistently and correctly. - Female subjects who are breast feeding should discontinue nursing before trial registration. - Before patient registration, written informed consent must be given according to ICH/GCP, and national/local regulations. Exclusion Criteria: - 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 - Treatment with any investigational drug substance within 4 weeks prior to registration. - 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 - 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) - Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before randomization in the trial. |
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science
Country | Name | City | State |
---|---|---|---|
Italy | Istituto Clinico Humanitas | Milano | |
United Kingdom | Royal Marsden Hospital - Sutton, Surrey | Sutton |
Lead Sponsor | Collaborator |
---|---|
European Organisation for Research and Treatment of Cancer - EORTC |
Italy, United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Percentage of Apparent Diffusion Coefficient (ADC) change | Percentage of Apparent Diffusion Coefficient (ADC) change at day 14 relative to baseline | day 14 relative to baseline | No |
Primary | Percentage of FLT uptake change | Percentage of FLT uptake change at day 14 relative to baseline | day 14 relative to baseline | No |
Primary | Pathological quantification (% viable residual tumor cells) | participants will receive chemotherapy for up to 12 weeks (4 cycles) and followed by surgery (with an expected surgical preparation of 2-4 weeks) | in average at week 16 from baseline | No |
Secondary | Pre-operative (post-treatment) ADC measurement | participants will receive chemotherapy for up to 12 weeks (4 cycles) and performed the DWI-MRI scan within one week prior to the surgery | in average at week 15 from baseline | No |
Secondary | Pre-operative (post-treatment) FLT uptake measurement | participants will receive chemotherapy for up to 12 weeks (4 cycles) and performed the FLT-PET scan within one week prior to the surgery | in average at week 15 from baseline | No |
Secondary | Tumor volume (baseline, day 14 and post-treatment) | baseline, day 14 and post-treatment | No | |
Secondary | Immunohistochemistry (IHC) cell proliferation marker Ki-67 | Immunohistochemistry (IHC) cell proliferation marker Ki-67-index in diagnostic biopsy samples (if available) and surgical specimens. | 1y | No |
Secondary | Metabolic change from FDG-PET (if available) | standard imaging per routine practice | in average at week 9 from baseline | No |
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