Early Positron Emission Tomography as a Predictor of Response in Neoadjuvant Chemotherapy for Non-Small Cell Lung Cancer
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- University of Washington
- Enrollment
- 25
- Locations
- 2
- Primary Endpoint
- Positron Emission Tomography as a Predictor of Response Measured by the Decrease in Standard Uptake Variable (SUV) After 1 Course of Therapy
Study Overview
Brief Summary
RATIONALE: Diagnostic procedures, such as positron emission tomography (PET), (done before, during, and after chemotherapy) may help doctors predict a patient's response to treatment and help plan the best treatment. Drugs used in chemotherapy, such as pemetrexed disodium and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving combination chemotherapy after surgery may kill any tumor cells that remain after surgery.
PURPOSE: This phase II trial is studying how well PET works in predicting response in patients who are undergoing treatment with pemetrexed disodium and cisplatin with or without surgery for stage I, stage II, or stage III non-small cell lung cancer.
Detailed Description
OBJECTIVES:
Primary
- 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 cancer (NSCLC).
Secondary
- 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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 120 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Neoadjuvant therapy, PET scan and surgery
Intervention: pemetrexed disodium (Drug)
Neoadjuvant therapy, PET scan and surgery
Intervention: adjuvant therapy (Procedure)
Neoadjuvant therapy, PET scan and surgery
Intervention: cisplatin (Drug)
Neoadjuvant therapy, PET scan and surgery
Intervention: therapeutic conventional surgery (Procedure)
Neoadjuvant therapy, PET scan and surgery
Intervention: fludeoxyglucose F 18 (Radiation)
Outcomes
Primary Outcomes
Positron Emission Tomography as a Predictor of Response Measured by the Decrease in Standard Uptake Variable (SUV) After 1 Course of Therapy
Time Frame: Between days 18 and 22 prior to second chemotherapy infusion
Number of Participants with Decrease in Standard Uptake Variable (SUV) After 1 Course of Therapy
Secondary Outcomes
- Safety of Neoadjuvant Chemotherapy(Up to 4 weeks after last dose of chemotherapy)
- Efficacy of Neoadjuvant Chemotherapy as Measured by Radiologic Response Rate(Up to 4 weeks after last dose of chemotherapy)
Investigators
Renato Martins
Principal Investigator
University of Washington