A Randomized Phase II Study Assessing the Efficacy of Local Consolidative Therapy for Non-Small Cell Lung Cancer Patients With Oligometastatic Disease
In order to be eligible for this study, you will have already received 4-6 cycles of
induction chemotherapy with platinum doublet chemotherapy (such as carboplatin and
paclitaxel), erlotinib (for patients with known epidermal growth factor receptor (EGFR)
mutations), or crizotinib (for patients with known EML4-ALK fusion) without the disease
getting worse.
Study Groups:
You will be randomly assigned (as in the flip of a coin) to 1 of 2 groups:
Group 1 will receive local consolidation therapy (LCT) after induction chemotherapy. LCT is
radiation, surgery, or both. If you are assigned to the LCT group, the study doctor will
decide if you will have radiation alone, surgery alone, or radiation combined with surgery.
Group 2 will not receive LCT after induction chemotherapy. The treatment you receive will
depend on what the study doctor thinks is in your best interest.
Group 1 - Local Consolidation Therapy (LCT):
Each study cycle is 6 weeks, but may vary if your doctor thinks it is in your best interest.
Surgery:
You will be given a separate consent form to sign that describes the surgical procedure and
its risks in more detail. The type of surgery you will have will depend on the status of
the disease.
Radiation Therapy:
About 1-2 weeks before you begin radiation therapy, you will have a procedure called a
simulation. During the simulation, the exact location for the radiation therapy will be
planned. The simulation procedure takes about 1 hour.
You will receive radiation daily (Monday through Friday) for a period lasting from 1 day up
to 8 weeks, depending on the location and status of the disease. The radiation only takes a
few minutes to administer each day. However, you will be asked to allow about 1 hour each
day for the procedure.
You will be given a separate consent form to sign that describes the radiation therapy and
its risks in more detail. The type of radiation therapy you will have will depend on the
status of the disease.
Group 2 - No Local Consolidation Therapy (LCT):
If you are in Group 2, you will not be receiving surgery or radiation therapy right after
induction chemotherapy. If you are randomized to this arm, you will receive either systemic
therapy (i.e. chemotherapy) or observation. The care you receive will depend on what your
doctor thinks is in your best interest.
Chemotherapy:
Each study cycle is 6 weeks, but may vary if your doctor thinks it is in your best interest.
If you receive chemotherapy, either after your 4-6 cycles of induction chemotherapy is
complete or after receiving LCT, your treating physician will decide the type of
chemotherapy you will receive.
You will be given a separate consent form to sign that describes the chemotherapy and its
risks in more detail. The type of chemotherapy you will have will depend on the status of
the disease.
Study Visits:
If the study doctor thinks it is needed, the following tests and procedures may be performed
before and/or during chemotherapy and/or radiation
- A physical exam will be performed, including measurement of your vital signs.
- Your performance status will be recorded.
- Your medical history will be recorded.
- You will be asked about any side effects you may be having.
- Blood (about 2 teaspoons) will be drawn for routine tests.
During chemotherapy, if the study doctor thinks it is needed, you may also have a computed
tomography (CT) scan, positron emission tomography (PET) scan, and/or magnetic resonance
imaging (MRI) scan to check the status of the disease. These imaging scans will be done
about every 6-8 weeks during the first year of the study to check the status of the disease.
Length of Treatment:
You may continue receiving the study treatment for up to 2 years or as long as the doctor
thinks it is in your best interest. You will no longer be able to receive the study
treatment if the disease gets worse, if intolerable side effects occur, or if you are unable
to follow study directions.
Your participation on the study will be over after the follow-up visits.
Follow-Up Visits:
All study participants will have follow-up visits after the surgery is complete, or after
the last dose of radiation or chemotherapy, depending on which treatment you were assigned
to. During each follow-up visit, you may have the following tests and procedures performed
if the study doctor thinks it is needed:
- You will have a physical exam, including measurement of your vital signs (blood
pressure, heart rate, temperature, and breathing rate).
- Your performance status will be recorded.
- Your medical history will be recorded.
- You will be asked about any side effects you may be having.
- You will have lung function tests to check the status of the disease.
- You will have a CT scan to check the status of the disease.
- Blood (about 2 teaspoons) will be drawn for routine tests.
- Your oxygen level will be measured using a small device that is placed on the tip of
your finger.
Other Information:
If at any time while you are on study your treating physician thinks it is in your best
interest, you may be switched to the other treatment option (LCT to no LCT or vice versa).
This is an investigational study. The combination of LCT after chemotherapy for the
treatment of NSCLC is being used for research purposes only.
Up to 94 patients will take part in this study. Up to 55 will be enrolled at MD Anderson.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Progression-Free Survival (PFS)
Progression-free survival (PFS) defined as time from the time of randomization (LCT vs. no LCT) to disease progression or death. For the primary endpoint, PFS, Kaplan-Meier estimate will be computed and the log-rank test will be performed to compare the difference of PFS between the two arms.
4 months
No
Daniel Gomez, MD
Principal Investigator
UT MD Anderson Cancer Center
United States: Food and Drug Administration
2012-0618
NCT01725165
November 2012
Name | Location |
---|---|
University of Colorado | Denver, Colorado 80217 |
University of Chicago | Chicago, Illinois 60637 |
UT MD Anderson Cancer Center | Houston, Texas 77030 |