Viewing Study NCT00002930



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Last Modification Date: 2024-10-26 @ 9:03 AM
Study NCT ID: NCT00002930
Status: COMPLETED
Last Update Posted: 2013-01-18
First Post: 1999-11-01

Brief Title: PET Scan in Patients With Lung and Esophageal Cancers That May Be Removed by Surgery
Sponsor: Memorial Sloan Kettering Cancer Center
Organization: Memorial Sloan Kettering Cancer Center

Study Overview

Official Title: Whole-Body 18F-Fluorodeoxyglucose Positron Emission Tomography to Measure the Response to Induction Chemotherapy of Potentially Resectable Lung and Esophageal Carcinomas
Status: COMPLETED
Status Verified Date: 2013-01
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: RATIONALE Imaging procedures such as fludeoxyglucose F 18 positron emission tomography PET scans may improve the ability to detect lung and esophageal cancer or their recurrence

PURPOSE Phase IIIII trial to study the effectiveness of fludeoxyglucose F 18 PET scans in measuring response to induction chemotherapy in patients with esophageal and lung cancer that may be removed by surgery
Detailed Description: OBJECTIVES I Determine whether whole body fludeoxyglucose F 18 F-18 2-fluoro-2-deoxy-D-glucose FDG positron emission tomography PET can quantitate the response to induction preoperative chemotherapy in patients with esophageal or non-small cell lung cancer NSCLC by correlating changes in PET scan images with surgical staging frequency of complete resection disease-free survival and overall survival II Correlate PET scan results with the multiple conventional complementary imaging modalities of thoracic andor abdominal CT bone scans and cranial MRI III Evaluate the use of PET scanning to uncover disease sites undetected by current imaging modalities

OUTLINE This is a nonrandomized study The choice of chemotherapeutic regimen is at the discretion of the medical oncologist If the tumor is resectable after treatment with chemotherapy the patients undergoes the appropriate resection as defined by the thoracic surgeon All patients have positron emission tomography PET scans done within 2 weeks before the first dose of chemotherapy and again about 2-3 weeks after the third or fourth dose of chemotherapy Patients are asked to not eat or drink 6 hours before coming into the hospital for the PET scan They are administered an injection of a solution of fluorodeoxyglucose F 18 FDG and then undergo a PET scan

PROJECTED ACCRUAL An estimated 75 patients 50 lung cancer and 25 esophageal cancer patients will be accrued into this protocol over 24-30 months

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None
Secondary IDs
Secondary ID Type Domain Link
NCI-G97-1334 US NIH GrantContract None httpsreporternihgovquickSearchP30CA008748
P30CA008748 NIH None None
MSKCC-96079 None None None