Non-Small Cell Lung Cancer Clinical Trial
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
Verified date | January 2020 |
Source | National Institutes of Health Clinical Center (CC) |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
...
Status | Completed |
Enrollment | 41 |
Est. completion date | December 17, 2019 |
Est. primary completion date | April 13, 2007 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 100 Years |
Eligibility |
- 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. |
Country | Name | City | State |
---|---|---|---|
United States | University of North Carolina at Chapel Hill | Chapel Hill | North Carolina |
Lead Sponsor | Collaborator |
---|---|
National Institute of Environmental Health Sciences (NIEHS) |
United States,
Hansen E, Wolff N, Knuechel R, Ruschoff J, Hofstaedter F, Taeger K. Tumor cells in blood shed from the surgical field. Arch Surg. 1995 Apr;130(4):387-93. — View Citation
Kurusu Y, Yamashita J, Hayashi N, Mita S, Fujino N, Ogawa M. The sequence of vessel ligation affects tumor release into the circulation. J Thorac Cardiovasc Surg. 1998 Jul;116(1):107-13. — View Citation
Pantel K, Izbicki J, Passlick B, Angstwurm M, Häussinger K, Thetter O, Riethmüller G. Frequency and prognostic significance of isolated tumour cells in bone marrow of patients with non-small-cell lung cancer without overt metastases. Lancet. 1996 Mar 9;347(9002):649-53. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Determine the effect of initial venous versus arterial ligation during resection for NSCLC on the risk of distant metastases within two years of follow-up | Risk of metastases recurrence after tumor resection | 2 years |
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