PET Scan in Patients With Lung and Esophageal Cancers That May Be Removed by Surgery

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT00002930
First received: November 1, 1999
Last updated: January 17, 2013
Last verified: January 2013
  Purpose

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 II/III 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.


Condition Intervention Phase
Esophageal Cancer
Lung Cancer
Procedure: positron emission tomography
Radiation: fludeoxyglucose F 18
Phase 2
Phase 3

Study Type: Interventional
Study Design: Primary Purpose: Diagnostic
Official Title: Whole-Body 18F-Fluorodeoxyglucose Positron Emission Tomography to Measure the Response to Induction Chemotherapy of Potentially Resectable Lung and Esophageal Carcinomas

Resource links provided by NLM:


Further study details as provided by Memorial Sloan-Kettering Cancer Center:

Estimated Enrollment: 75
Study Start Date: December 1996
Primary Completion Date: October 2002 (Final data collection date for primary outcome measure)
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 and/or 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS: Histologically confirmed esophageal or non-small cell lung carcinoma Esophageal cancer: Biopsy proven esophageal carcinoma considered acceptable for curative esophageal resection Lung cancer: Stages IA-IIIB, T(any)N(any)M0 disease without pleural effusion, which constitutes locally advanced lung cancer Must be candidates for induction chemotherapy followed by surgical resection

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 70-100% Life expectancy: Not specified Hematopoietic: WBC at least 4,000/mm3 Platelet count at least 160,000/mm3 Hepatic: Bilirubin no greater than 1.0 mg/dL Renal: Creatinine no greater than 1.5 mg/dL Creatinine clearance greater than 65 mL/min Other: Not pregnant Adequate contraception required of all fertile female patients

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease Characteristics Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: No prior surgical mediastinal staging such as prior mediastinoscopy or Chamberlain procedures See Disease Characteristics

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002930

Locations
United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
Investigators
Study Chair: Robert J. Downey, MD Memorial Sloan-Kettering Cancer Center
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00002930     History of Changes
Other Study ID Numbers: 96-079, P30CA008748, MSKCC-96079, NCI-G97-1334
Study First Received: November 1, 1999
Last Updated: January 17, 2013
Health Authority: United States: Federal Government

Keywords provided by Memorial Sloan-Kettering Cancer Center:
stage I non-small cell lung cancer
stage II non-small cell lung cancer
stage I esophageal cancer
stage II esophageal cancer
stage III esophageal cancer
stage IIIA non-small cell lung cancer
stage IIIB non-small cell lung cancer

Additional relevant MeSH terms:
Esophageal Neoplasms
Lung Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on April 20, 2014