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Study of Patients With Non-Small Cell Lung Cancer, Esophageal Cancer, Malignant Pleural Mesothelioma, Mediastinal or Chest Wall Neoplasms, or Lung Metastases From Cancers of Non-Thoracic Origin

Published: March 13, 2007

Primary Outcome Measures:

  • Identification of patients who are suitable candidates for clinical research protocols [ Designated as safety issue: No ]
  • Biopsies [ Designated as safety issue: No ]


  • Evaluate patients referred to the Thoracic Oncology Section of the Surgery Branch, NCI in order to identify patients who are suitable candidates for clinical research protocols.
  • Obtain biopsies during staging studies of tumor and adjacent normal tissues as well as serum and urine samples from patients with primary aerodigestive tract malignancies to support preclinical research endeavors in the Thoracic Oncology Section.
  • Permit standard treatment for patients who are not eligible for investigational therapy on a current Thoracic Oncology protocol, but who present a novel and unique clinical training opportunity, or who manifest a clinical condition that requires immediate intervention to prevent compromise to the patient’s well-being.
  • Permit long-term follow up of patients with thoracic malignancies, including the collection of tissue and fluids to support preclinical research, particularly to ascertain if gene expression and DNA methylation profiles coincide with response to therapy.
  • Obtain blood, tumor tissue, or malignant peritoneal/pleural effusions from patients with lung, esophageal, mediastinal, or chest wall malignancies for ex vivo generation of autologous tumor cell lines and EBV-transformed B-cell lines for research.

Outline: This is a prospective study.

Patients undergo bronchoscopy. Tumor tissue and normal tissue are collected via endoscopy, fine-needle aspiration, core-needle techniques, or single-port site thoracoscopic methods. Biopsies are examined for gene expression and DNA methylation analysis. Blood and urine are also collected.

Projected Accural: A total of 375 patients will be accrued for this study.


Disease Characteristics:
  • Histologically or cytologically confirmed or radiographic evidence of primary non-small cell lung cancer, esophageal cancer, malignant pleural mesothelioma, mediastinal or chest wall neoplasms, or pulmonary metastases from cancers of non-thoracic origin
  • Intracranial metastases potentially treatable with surgery and/or radiotherapy allowed
Patient Characteristics:
  • ECOG performance status 0-2
  • ANC ≥ 1,000/mm³
  • Platelet count ≥ 75,000/mm³
  • PT ≤ 16 OR INR ≤ 2
  • Creatinine < 2.5 g/dL
  • Bilirubin ≤ 2 times upper limit of normal
Prior Concurrent Therapy:
  • Not specified
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