Prevention of Tumor Spread Due to Lung Cancer Surgery
| Status: | Completed |
|---|---|
| Conditions: | Lung Cancer, Lung Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - 100 |
| Updated: | 4/6/2019 |
| Start Date: | September 24, 2002 |
Venous or Arterial Ligation and Intraoperative Dissemination (VALID) of Cancer Cells: A Randomized Clinical Trial For Patients With Resectable Non-Small Cell Lung Cancer
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.
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.
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.
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.
- 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.
We found this trial at
1
site
University of North Carolina at Chapel Hill Carolina’s vibrant people and programs attest to the...
Click here to add this to my saved trials
