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Whole-Body 18F-Fluorodeoxyglucose Positron Emission Tomography to Measure the Response to Induction Chemotherapy of Potentially Resectable Lung and Esophageal Carcinomas


Phase 2/Phase 3
18 Years
N/A
Not Enrolling
Both
Esophageal Cancer, Lung Cancer

Thank you

Trial Information

Whole-Body 18F-Fluorodeoxyglucose Positron Emission Tomography to Measure the Response to Induction Chemotherapy of Potentially Resectable Lung and Esophageal Carcinomas


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Primary Purpose: Diagnostic

Principal Investigator

Robert J. Downey, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Federal Government

Study ID:

96-079

NCT ID:

NCT00002930

Start Date:

December 1996

Completion Date:

Related Keywords:

  • Esophageal Cancer
  • Lung Cancer
  • 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
  • Esophageal Diseases
  • Esophageal Neoplasms
  • Lung Neoplasms

Name

Location

Memorial Sloan-Kettering Cancer CenterNew York, New York  10021