Early Positron Emission Tomography as a Predictor of Response in Neoadjuvant Chemotherapy for Non-Small Cell Lung Cancer
- Determine the effectiveness of fludeoxyglucose F 18 positron emission tomography in
predicting radiological and pathological response in patients treated with pemetrexed
disodium and cisplatin with or without surgery for stage IB-IIIB non-small cell lung
- Determine the safety of cisplatin and pemetrexed disodium in these patients.
- Determine the radiographic response rate, duration of response, and time to progression
in patients treated with cisplatin and pemetrexed disodium.
OUTLINE: This is a multicenter study.
- Fludeoxyglucose F 18 (18FDG) positron emission tomography (PET) imaging: All patients
undergo positron emission tomography (PET) imaging of the head, neck, thorax, abdomen,
and pelvis. Patients receive fludeoxyglucose F 18 (^18FDG) IV followed by 45 minutes of
rest. PET imaging is done over 1 hour and 8 minutes. Patients undergo PET imaging at
three points during the study: 4 weeks prior to treatment, after the first cycle of
treatment, and after 3 courses of chemotherapy. Some patients then undergo surgical
resection of the tumor.
- Chemotherapy: Patients receive cisplatin IV over 30 minutes and pemetrexed disodium IV
over 10 minutes on day 1. Courses repeat every 21 days for up to 3 courses in the
absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed every 3 months for 2 years and
then every 6 months for 3 years.
PROJECTED ACCRUAL: A total of 35 patients will be accrued for this study.
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Positron emission tomography as a predictor of response measured by the decrease in standard uptake variable (SUV) after 1 course of therapy
Between days 18 and 22 prior to second chemotherapy infusion
Renato Martins, MD, MPH
Seattle Cancer Care Alliance
United States: Federal Government
|University of Washington School of Medicine||Seattle, Washington 98195|
|Seattle Cancer Care Alliance||Seattle, Washington 98109|