Prevention of Tumor Spread Due to Lung Cancer Surgery

NCT00341380 | Completed

• 2 other identifiers: 99990231902-E-N319
• Study Type: observational
• Target: 41
• Locations: 1 country
• Sites: 1

Brief Summary

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. ...

Conditions

Non-Small Cell Lung Cancer

Keywords

Cancer; Lung Cancer; Surgical Resection; Non-Small Cell Lung Cancer; NSCLC

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Patients

Undergoing resection of lung tumor

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients 18 or older with Stage I or II non-small cell lung cancer and no evidence of tumor spread beyond the lung.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Institute of Environmental Health Sciences (NIEHS): lead

Study Sites (1)

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States

Location

Related Publications (3)

• 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. doi: 10.1001/archsurg.1995.01430040049007.

  PMID: 7710337 BACKGROUND

• 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. doi: 10.1016/s0022-5223(98)70248-x.

  PMID: 9671904 BACKGROUND

• Pantel K, Izbicki J, Passlick B, Angstwurm M, Haussinger K, Thetter O, Riethmuller 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. doi: 10.1016/s0140-6736(96)91203-9.

  PMID: 8596379 BACKGROUND

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Neoplasms; Lung Neoplasms

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Jack Taylor, M.D.

  National Institute of Environmental Health Sciences (NIEHS)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH

Study Record Dates

• First Submitted: June 19, 2006
• First Posted: June 21, 2006
• Study Start: September 24, 2002
• Primary Completion: April 13, 2007
• Study Completion: December 17, 2019
• Last Updated: January 6, 2020

Record last verified: 2020-01

Locations

US (1)