Maintenance Chemotherapy With or Without Local Consolidative Therapy in Treating Patients With St… (NCT03137771) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Maintenance Chemotherapy With or Without Local Consolidative Therapy in Treating Patients With Stage IV Non-small Cell Lung Cancer
United States, Canada, Israel218 participantsStarted 2017-04-07
Plain-language summary
This randomized phase II/III trial studies how well giving maintenance chemotherapy with or without local consolidation therapy works in treating patients with stage IV non-small cell lung cancer. Drugs used in maintenance chemotherapy, such as docetaxel, pemetrexed disodium, erlotinib hydrochloride, and gemcitabine work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Local consolidation therapy such as radiation/stereotactic body radiation or surgery may kill cancer cells left after initial treatment. Giving maintenance chemotherapy and local consolidation therapy together may work better than maintenance chemotherapy alone in treating patients with stage IV 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:
* Patients must have the psychological ability and general health that permits completion of the study requirements and required follow up
* Women of childbearing potential and men who are sexually active should be willing and able to use medically acceptable forms of contraception during the trial and for up to 180 days after completion of all treatment to prevent pregnancy or fathering a child.
* Pathologically proven diagnosis of NSCLC, with metastases (stage IV disease) present prior to registration; this includes patients newly diagnosed with metastatic disease or those initially diagnosed and treated for stage I-III NSCLC who ultimately develop limited metastases. Limited metastases is defined as 3 or fewer sites of metastatic disease
* Appropriate stage for study entry based on the following diagnostic workup:
* History/physical examination by a radiation oncologist (and a surgeon if surgery is planned) within 30 days prior to registration
* Imaging proof of limited metastatic disease and response to therapy/stable disease, by at least diagnostic quality CT chest through the adrenals or positron emission tomography (PET)/CT within 30 days prior to registration
* Zubrod performance status 0, 1, or 2 within 30 days prior to registration
* Adequate organ and hematologic/bone marrow function within 14 days prior to registration, defined as follows:
* Aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 2.5 × upper limit of normal (ULN)…
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.
1This trial is looking at whether adding local consolidative therapy — like radiation or surgery targeted at specific tumor sites — to maintenance chemotherapy is better than maintenance chemotherapy alone for stage IV non-small cell lung cancer; given my specific situation, is my cancer the type that might benefit from that kind of combined approach?
2Since this is a Phase 2 trial primarily measuring progression-free survival rather than overall survival, what does that mean for how confident we can be about whether this treatment actually helps people live longer, and how does that uncertainty affect whether this trial makes sense for me compared to established standard-of-care options?
3The trial is active but no longer enrolling new patients — does that mean there's any chance I could still be considered, or should we focus our energy entirely on other options right now?
4Local consolidative therapy could mean radiation or surgery to specific sites of disease, which can have significant side effects depending on where my tumors are — can you help me understand what the treatment demands and recovery might actually look like for someone in my situation?
5Are there results or interim data from this trial already available that you've seen, and if so, do they suggest anything meaningful about whether adding local consolidative therapy is showing a real benefit worth weighing against the added treatment burden?
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.
What they're measuring
1
[Phase II] Progression-free Survival
Timeframe: From randomization to first date of local or regional disease, distant metastases, second primary tumor, death, or last follow-up, whichever comes first. Maximum follow-up time at time of analysis was 5.4 years.
2
[Phase III] Overall Survival
Timeframe: From randomization to death or last follow-up.