Lung Cancer Clinical Trial
The Impact of Surgical Technique on Circulating Tumor DNA in Stage I-III Non-Small Cell Lung Cancer
Summary
This clinical trial compares the effect of pulmonary vein-first surgical technique to pulmonary artery-first surgical technique in decreasing circulating tumor cell deoxyribonucleic acid (ctDNA) in patients with stage I-III non-small cell lung cancer. Pulmonary vein first and pulmonary artery first surgical techniques are standard surgical techniques for the division of the blood vessels during lung resection surgery. Pulmonary vein-first surgical technique may reduce the risk of shedding tumor cells during surgery and influence long term overall survival.
Full Description
PRIMARY OBJECTIVE:
I. To determine the association between sequence of surgical resection and postoperative ctDNA levels at specified time points.
SECONDARY OBJECTIVE:
I. To determine the associated between sequence of surgical resection and postoperative ctDNA level and clinical oncologic outcomes.
II. To assess disease-free survival and the role of circulating tumor DNA in disease recurrence in patients with resectable non-small cell lung cancer.
OUTLINE: Patients are randomized to 1 of 2 groups.
GROUP I: Patients undergo pulmonary vein first approach surgical procedure on day of surgery.
GROUP II: Patients undergo pulmonary artery first approach surgical procedure on day of surgery.
After completion of surgery, patients are followed up at day 1, day 7, days 7-28, 4 months, every 6 months for 2 years, then every 6 months for up to 5 years
Eligibility Criteria
Inclusion Criteria:
Any patients 18 years of age or older with confirmed or suspected early-stage (stage I-III) NSCLC
Eligible and scheduled for surgical anatomic lung resection (e.g. lobectomy or segmentectomy) as routine clinical care for their disease
Exclusion Criteria:
Previous cancer diagnosis within 5 years (except ductal carcinoma in situ [DCIS] of the breast, superficial bladder cancer, non-melanoma skin primary, other malignancy that does not require treatment).
Preoperative chemotherapy, immunotherapy, or radiation therapy
Receipt of perioperative blood transfusion
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