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



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

For Condition: stage 2 non-small cell lung cancer,stage 1 non-small cell lung cancer,stage 2 esophageal cancer,stage 3B non-small cell lung cancer,stage 3A non-small cell lung cancer,stage 3 esophageal cancer,stage 1 esophageal cancer
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , Memorial Sloan-Kettering Cancer Center
Synopsis: 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.
Details: 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. PROTOCOL 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:
Study Type:
  Interventional, Diagnostic
Minimum Age/Maximum Age: 18 Years/
Genders: 
Protocol Entry Criteria: PROTOCOL ENTRY 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 --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 --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
Total Enrollment: 

Location and Contact Information:

Overall Study Official:
RobertDowney,  Study Chair,  Memorial Sloan-Kettering Cancer Center

Memorial Sloan-Kettering Cancer Center
New York City,  New York,  10021
United States
 


Additional Information:
Study ID Numbers:
  CDR0000065363;  MSKCC-96079,NCI-G97-1334
Study Start Date: December 1996
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002930

Other Stage 3b Non-Small Cell Lung Cancer Studies:
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2. Lymph Node Removal in Treating Patients With Stage I or Stage II Non-small Cell Lung Cancer

3. Radiofrequency Ablation During Surgery in Treating Patients With Non-Small Cell Lung Cancer

4. A Program to Quit Smoking With or Without Bupropion in Treating Patients With Stage I or II Non-Small Cell Lung Cancer Who Have Undergone Surgery

5. Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Non-Small Cell Lung Cancer

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