Neoadjuvant Platinum-based Chemotherapy for Patients With Resectable , Non-small Cell Lung Cancer… (NCT01443078) | Clinical Trial Compass
CompletedPhase 2
Neoadjuvant Platinum-based Chemotherapy for Patients With Resectable , Non-small Cell Lung Cancer With Switch to Chemotherapy Alternative in Nonresponders (NEOSCAN)
United States42 participantsStarted 2011-10
Plain-language summary
The purpose of this study is to test a new approach to the use of standard drugs before surgery in patients with lung cancer. This study will find out what effects, good and/or bad, that this approach has on the cancer.
It is routine to give chemotherapy prior to surgery in patients with this type of lung cancer, to help keep it from coming back. It is also routine to perform a special type of scan called a PET scan. This PET scan measures how active a cancer is by use of a special tracer made out of sugar. In this study, all patients will have a PET scan and then be treated with standard chemotherapy drugs, either pemetrexed and cisplatin if the cancer is a "non-squamous" cancer or gemcitabine and cisplatin if the cancer is a squamous cancer. In rare cases, the doctor will decide to give carboplatin instead of cisplatin. In most patients, a repeat PET scan will show that the tumor is decreasing and they will complete standard chemotherapy then go on to have surgery.
In some patients, a repeat PET scan will show that the tumor has not decreased enough. For these patients, the routine practice is to proceed with surgery. This research study will test whether switching from the standard treatment of pemetrexed and cisplatin or gemcitabine and cisplatin to a different treatment called vinorelbine and docetaxel is safe and effective. Vinorelbine and docetaxel are also standard chemotherapy drugs which work in a different way than pemetrexed or gemcitabine and cisplatin.
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:
* Pathologic confirmation of NSCLC at MSKCC
* Stages IB, IIA, IIB, IIIA or IIIB NSCLC
* Primary tumor must measure ≥ 2 cm on CT imaging (per PERCIST guidelines)
* Primary tumor must be FDG-avid with an SUVmax \>4.5 (to be consistent with PERCIST guidelines)
* Patients must be candidates for resection with curative intent
* Age ≥ 18 years
* Karnofsky performance status ≥ 70%
* Normal bone marrow function
* leukocytes ≥ 3,000/μl
* absolute neutrophil count ≥ 1,500/μl
* platelets ≥100,000/μl
* hemoglobin ≥9gm/dl.
* Adequate hepatic function
* Total bilirubin ≤1.5 x ULN
* AST ≤ 1.5 x UNL, ALT ≤ 1.5 x ULN
* Alkaline phosphatase ≤ 1.5x ULN
* Women of childbearing age must have a negative pregnancy test
* Men and women of childbearing potential must be willing to use effective contraception while on treatment and for at least 3 months thereafter
* Patients must have the ability to understand and the willingness to sign a written informed consent document
Exclusion Criteria:
* Patients must not be receiving any other investigational agents
* History of myocardial infarction or unstable angina within the past 12 months Patients with peripheral neuropathy \> grade 1
* Other serious illness or medical condition including unstable cardiac disease requiring treatment, history of significant neurologic or psychiatric disorders (including psychotic disorders, dementia, or seizures), or active uncontrolled infection.
* Patients with diabetes mellitus requiring insulin …
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.