CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 26 enrolled
Drug / intervention
Cisplatin +6 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00963807
NCT00963807Phase 2Completed

Phase II Single-Arm Trial Comparing the Use of FLT PET to Standard Computed Tomography to Assess the Treatment Response of Neoadjuvant Docetaxel and Cisplatin in Stage IB-IIIA Resectable Non-small Cell Lung Cancer

National Cancer Institute (NCI)·interventional·Posted Aug 24, 2009·Updated Mar 17, 2017

In Brief

A Phase 2 clinical trial evaluating Cisplatin, CT, and 5 other interventions for Recurrent Non-Small Cell Lung Carcinoma and 5 related conditions. Completed, enrolled 26 participants across 2 sites.

Detailed Summary

This study is being done to compare a special type of Positron Emission Tomography (PET) scan with CT scan in patients with surgically removable lung cancer to see which method is more useful in measuring a response to treatment. A PET scan uses small amounts of radioactive material injected into the blood to show the internal workings of the body. In this study, we will use two radioactive materials: 18F-FLT (referred to as FLT) and 18F-FDG (referred to as FDG). FDG is used routinely in the staging of lung cancer and is approved by the FDA for that purpose. FLT is used in the special type of PET scan being assessed by this study. In addition the study will assess the effects of the combination of docetaxel and cisplatin (chemotherapeutic drugs) on certain pathological characteristics of the tumor. The combination of docetaxel and cisplatin is approved by the Food and Drug Administration (FDA) for the treatment of advanced/metastatic NSCLC (non-small cell lung cancer). It is not approved for use in patients who have surgically removable NSCLC. In such cases cisplatin is used as a single drug therapy before surgery. The FDA is allowing the use of docetaxel along with cisplatin in this research study.

Study Details

Timeline

Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedAug 24, 2009
Enrollment StartSep 1, 2009
Primary CompletionAug 1, 2012
Study CompletionNov 1, 2014
TodayJul 2, 2026
Enrollment to primary: 2.9 yearsPosted 16.9 years ago

Interventions

Cisplatindrug

Given IV

CTprocedure

Undergo FDG PET/CT, FLT PET/CT and thoracic CT

Docetaxeldrug

Given IV

FDGdrug

Undergo FDG PET/CT

FLTdrug

Undergo FLT PET/CT

PET/CTprocedure

Undergo FDG PET/CT and FLT PET/CT

Surgeryprocedure

Undergo surgery