Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Prevention of Tumor Spread Due to Lung Cancer Surgery

This study has been completed.
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00341380
First received: June 19, 2006
Last updated: March 14, 2014
Last verified: February 2014
  Purpose

This study will investigate operative techniques to reduce the risk of tumor spread as a result of lung cancer surgery. Recent studies indicate that tumor cells may be released into the bloodstream due to handling of the lung during surgery, causing disease spread in patients whose tumor was previously confined to the lung. This study will examine whether the order in which the pulmonary vein (a vessel carrying blood from the lungs to the heart) and artery (vessel carrying blood from the heart to the lungs) are tied off during surgery affects the risk of tumor spread and disease recurrence.

Patients 18 years of age or older with operable Stage I or Stage II non-small cell lung cancer and no evidence of tumor spread beyond the lung may be eligible for this study. Candidates will be screened with a medical history, blood tests, chest X-ray, and possibly mediastinal evaluation. This test involves inserting a tube into the chest cavity to look for signs of disease spread beyond the lung.

All participants will undergo standard surgery for lung cancer. During the procedure, both the pulmonary artery and pulmonary vein are tied off; for this study, patients will be randomly assigned to have either the artery or the vein ligated first. Patients will be followed every 6 months for two years with blood tests and X-rays to look for disease recurrence.


Condition Intervention Phase
Lung Cancer
Non-Small Cell Lung Cancer
Procedure: X-Ray
Procedure: Blood Tests
Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: Venous or Arterial Ligation and Intraoperative Dissemination (VALID) of Cancer Cells: A Randomized Clinical Trial For Patients With Resectable Non-Small Cell Lung Cancer

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Primary Outcome Measures:
  • Presence of one or more distant metastases at 2 years after the resection of the tumor.

Estimated Enrollment: 120
Study Start Date: September 2002
Study Completion Date: April 2007
Primary Completion Date: April 2007 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: X-Ray
    N/A
    Procedure: Blood Tests
    N/A
Detailed Description:

The VALID study is designed to obtain information regarding factors associated with the risk of recurrence after resection of early stage Non-Small Cell Lung Cancer (NSCLC). Until recently, the only clearly identified prognostic factor was the stage of the disease. Recent development of sensitive molecular assays has provided a way to study the effect of circulating tumor cells on clinical outcome. Preliminary studies have shown that tumor cells detected by such means in lymph nodes or in bone marrow are associated with an increased risk of recurrence. Preliminary studies have also indicated that the level of circulating tumor cells in the blood stream is effected by intraoperative factors, i.e. the sequence of vessel ligation.

The main objective for this study is to investigate the influence of intraoperative sequence of vessel ligation and how this affects tumor recurrence and survival. In addition, we will also investigate the use of molecular assays to detect circulating tumor cells as a surrogate endpoint for the occurrence of distant metastases and/or death after surgery for NSCL. Several of these molecular markers have proven their value in case series but have not been rigorously tested for association with the clinical endpoints of interest, tumor recurrence and survival. We believe that this study may lead to important answers about how the spread of tumor cells occurs and if novel detection methods can be used to predict patient outcome.

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria
  • INCLUSION CRITERIA:

Patients for this study will be identified through the Multidisciplinary Thoracic Oncology Clinic at UNC. Enrollment criteria for the study are: 1) Surgically respectable Stage I or II non-small cell lung carcinoma; 2) Negative mediastinal evaluation; 3) No contraindications for surgery; and 4) More than 18 years of age.

EXCLUSION CRITERIA:

Patients with prior carcinoma within 5 years (except basal cell carcinoma of the skin and superficial bladder cancer) will be excluded from the study. Patients who are enrolled based on clinical Stage I or II but are revised to higher Stage once the surgical specimens are examined will be excluded from statistical analysis.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00341380

Locations
United States, North Carolina
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States
Sponsors and Collaborators
Investigators
Principal Investigator: Jack Taylor, M.D. National Institute of Environmental Health Sciences (NIEHS)
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00341380     History of Changes
Other Study ID Numbers: 999902319, 02-E-N319
Study First Received: June 19, 2006
Last Updated: March 14, 2014
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Lung Cancer
Tumor Marker
Gene Expression
Non-Small Cell Lung Cancer
NSCLC

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Bronchial Neoplasms
Carcinoma, Bronchogenic
Lung Diseases
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms

ClinicalTrials.gov processed this record on November 20, 2014