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.

Completed

• Conditions: Lungcancer; non-small cell lung cancer; 10038666

• Registration Number: NL-OMON42040
• Lead Sponsor: European Organisation for Research in Treatment of Cancer (EORTC)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 4

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 < 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.
* Absence of 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.
* Before patient registration, written informed consent must be given according to ICH/GCP, and national/local regulations.

Exclusion Criteria

- Does not meet the inclusion criteria
- Younger than 50 years

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>* Percentage of ADC change at day 14 (i.e. ADC-2) relative to baseline (i.e.<br /><br>ADC-1)<br /><br>* Percentage of FLT uptake change at day 14 (i.e. SUV-2) relative to baseline<br /><br>(i.e. SUV-1)<br /><br>* Pathological quantification (% viable tumor cells) measured in surgical<br /><br>specimens</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>* Pre-operative (post-treatment) ADC measurement (i.e. ADC-3)<br /><br>* Pre-operative (post-treatment) FLT uptake measurement (i.e. SUV-3)<br /><br>* Tumor volume (baseline and pre-operative) measured by CT or MRI<br /><br>* Immunohistochemistry (IHC) of cell proliferation marker Ki-67-index in<br /><br>diagnostic biopsy samples (if available) and surgical specimens.<br /><br>* Metabolic change in FDG-PET (baseline and pre-operative, if available)<br /><br>* Safety</p><br>