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Procedure
Surgical Procedures for Early-Stage Lung Cancer
Phase 3
Waitlist Available
Research Sponsored by Alliance for Clinical Trials in Oncology
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
No prior chemotherapy or radiation therapy for this malignancy
ECOG performance status of 0-2
Must not have
Pure ground glass opacities or pathologically confirmed N1 or N2 disease
Node levels 4, 7, and 10 not diagnosed as negative on frozen section for right sided tumors
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Summary
This trial is comparing wedge resection, segmentectomy, and lobectomy to see which is more effective in treating stage IA non-small cell lung cancer.
Who is the study for?
This trial is for adults over 18 with early-stage IA non-small cell lung cancer. Candidates should have a small lung nodule presumed to be cancer, located in the outer part of the lung, and no advanced or metastatic disease. They must not have had other cancers (except certain skin, bladder, or cervical cancers) in the past 3 years and no prior treatments for this cancer.
What is being tested?
The study is comparing two less invasive surgical methods—segmentectomy or wedge resection—with lobectomy to see which one works better for stage IA non-small cell lung cancer. Patients will be randomly assigned to undergo one of these surgeries.
What are the potential side effects?
Potential side effects from these surgeries may include pain at the surgery site, shortness of breath, fatigue during recovery, risk of infection, and complications related to anesthesia.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I haven't had chemotherapy or radiation for my cancer.
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I can take care of myself and am up and about more than half of the day.
Select...
My lung nodule is 2 cm or smaller, located on the outer part of my lung, and presumed to be cancer.
Select...
My cancer has not spread beyond its original location.
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My tumor can be removed by surgery.
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I am 18 years old or older.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
My lung scans show ground glass opacities or I have N1 or N2 lung cancer.
Select...
My right-sided tumor's nodes 4, 7, and 10 were not confirmed negative.
Select...
My left-sided tumor's lymph nodes at levels 5, 6, 7, and 10 were not confirmed negative.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Trial Design
2Treatment groups
Experimental Treatment
Group I: Arm BExperimental Treatment1 Intervention
Patents undergo a limited resection (segentectomy or wedge resection), which a smaller portion of the lung is removed.
Group II: Arm AExperimental Treatment1 Intervention
Patients undergo a standard operation for lung cancer called a lobectomy.
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)NIH
13,842 Previous Clinical Trials
41,002,299 Total Patients Enrolled
Alliance for Clinical Trials in OncologyLead Sponsor
512 Previous Clinical Trials
216,771 Total Patients Enrolled
Nasser Altorki, MDStudy ChairWeill Medical College of Cornell University
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't had chemotherapy or radiation for my cancer.My lung scans show ground glass opacities or I have N1 or N2 lung cancer.Your doctor hasn't confirmed that there is no cancer spread using a quick frozen tissue test.My right-sided tumor's nodes 4, 7, and 10 were not confirmed negative.I can take care of myself and am up and about more than half of the day.I haven't had cancer, except for certain skin, bladder, or cervical cancers, in the last 3 years.My left-sided tumor's lymph nodes at levels 5, 6, 7, and 10 were not confirmed negative.My lung nodule is 2 cm or smaller, located on the outer part of my lung, and presumed to be cancer.Lymph nodes that were confirmed to have cancer during a quick frozen section test.My cancer has not spread beyond its original location.You have not had a biopsy to confirm that you have non-small cell lung cancer.My tumor can be removed by surgery.I am 18 years old or older.
Research Study Groups:
This trial has the following groups:- Group 1: Arm B
- Group 2: Arm A
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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