Lymph Node Removal in Treating Patients With Stage I or Stage II Non-small Cell Lung Cancer (NCT00003831) | Clinical Trial Compass
CompletedPhase 3
Lymph Node Removal in Treating Patients With Stage I or Stage II Non-small Cell Lung Cancer
United States, Australia, Canada1,023 participantsStarted 1999-07
Plain-language summary
RATIONALE: Surgical removal of all lymph nodes in the chest may kill cancer cells that have spread from tumors in the lung. It is not yet known whether complete removal of all lymph nodes in the chest is more effective than removal of selected lymph nodes in treating patients who have stage I or stage II non-small cell lung cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of complete removal of all lymph nodes in the chest with that of selected removal of lymph nodes during lung cancer surgery in treating patients who have stage I or stage II non-small cell lung cancer.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Patient must be ≥18 years of age.
. Patient must have an ECOG/Zubrod performance status of ≤ 3.
. Patient must have tissue diagnosis of a clinically resectable T1 or T2, N0 or non-hilar N1, M0 NSCLC (squamous cell carcinoma, large cell carcinoma or adenocarcinoma including bronchoalveolar carcinoma) established prior to randomization. NOTE: A patient without a pre-operative tissue diagnosis, but with clinically suspected NSCLC that fits the above criteria is eligible provided the tissue diagnosis is confirmed intraoperatively.
. Patient must have pre-operative imaging procedure, CT scan of the chest and upper abdomen to include liver and adrenal glands to determine eligibility, within 60 days of the date of the pulmonary resection.
. Patient that has not had a mediastinoscopy should have no mediastinal adenopathy on the CT of the chest defined as no lymph node \> 1 cm in the shortest axis.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. Patient is a candidate for a complete resection of the carcinoma via pneumonectomy,lobectomy, bilobectomy, or anatomic segmentectomy with or without sleeve resection,as noted in the surgical plan.
. Patient, or patient's legally acceptable representative, must provide a signed and dated Z0030-specific written informed consent prior to registration and any study-related procedures.
. If patient is a survivor of a prior cancer, the following criteria are met:
Exclusion criteria
. Patient has N2 disease determined at pre-operative mediastinoscopy or on sampling.
. Patient has T3 or T4 tumor.
. Patient is having only a wedge resection performed for treatment.
. Patient has received prior chemotherapy or radiotherapy for this cancer.