Radiation Therapy Followed by Chemotherapy for Newly Diagnosed Patients With Stage I/II Nasal NK Cell Lymphoma
The Study Treatments:
Radiation therapy is designed to kill cancer cells or to stop cancer cells from growing.
CHOP chemotherapy is made up of the drugs cyclophosphamide, hydroxydaunorubicin
(doxorubicin), oncovin (vincristine), and prednisone. It is designed to help control the
tumor locally as well as the tumor cells that might have escaped and moved through the body.
Radiation Therapy:
You will receive radiation therapy 5 days a week for 28 to 30 treatments. You will receive
a separate consent form that will describe this procedure and its risks in more detail.
Study Visits During Radiation Therapy:
Every week for 6 weeks during radiation therapy:
- You will be asked how you are feeling and about any side effects you may be having.
- Your performance status will be recorded.
- You will have a physical exam.
Chemotherapy Administration:
The amount of time after you finish radiation therapy before you can begin receiving
chemotherapy will depend on your recovery time and any side effects you may have. This
should be about 3-4 weeks.
On Day 1 you will receive cyclophosphamide by vein over 1 hour, doxorubicin by vein over 15
minutes, and vincristine by vein over 15 minutes. You will take prednisone by mouth on Days
1-5 of each cycle. Each cycle will be 21-days long (or longer if it takes longer for your
blood counts to recover). You will receive up to 4 cycles of chemotherapy.
Study Visits During Chemotherapy:
Before Day 1 of Cycle 1:
- You will have a CT scan of head, neck, chest, abdomen and pelvis.
- You will have an MRI scan of the head and neck.
- You will be asked about any drugs you may be taking and symptoms you may be having.
- Your performance status will be recorded.
- You will have a physical exam, including measurement of your height and weight.
- You will have an ECHO and MUGA scan.
- You will have an x-ray of the chest.
- You will have an ECG.
- Blood (about 2 teaspoons) will be drawn for routine tests.
- If you are able to become pregnant, you will have a blood (about 2 teaspoons) pregnancy
test.
On Day 15 of Cycle 1:
- You will be asked about any drugs you may be taking and symptoms you may be having.
- Your performance status will be recorded.
- Blood (about 2 teaspoons) will be drawn for routine tests.
On Day 1 of Cycles 2-4:
- You will be asked about any drugs you may be taking and symptoms you may be having.
- Your performance status will be recorded.
- You will have an ECG.
- Blood (about 2 teaspoons) will be drawn for routine tests.
On Day 15 of Cycles 2-4:
-Blood (about 2 teaspoons) will be drawn for routine tests.
Length of Study:
You may receive radiation and up to 4 cycles of CHOP. You will no longer be able to
receive CHOP if the disease gets worse or intolerable side effects occur.
Your participation on the study will be over after the end-of-study and follow-up visits.
Follow-Up and End-of-Study Visits:
If you leave the study early:
- You will have a CT scan of head, neck, chest, abdomen and pelvis.
- You will have an MRI scan of the head and neck.
- You will have a PET/CT scan.
- Any skin lesions that you may have that are related to the tumor will be measured and
photographed.
- You will be asked about any drugs you may be taking and symptoms you may be having.
- Your performance status will be recorded.
- You will have a physical exam.
- Blood (about 2 teaspoons) will be drawn for routine tests.
Routine Follow-up:
- You will also have routine follow-up visits every 3 months for the 1st year, every 4
month during the 2nd year, and every 6 months during the 3rd-5th years. After that,
you will have follow up visits 1 time every year. At these visits, the following tests
and procedures will be recorded:
- You will have a CT scan of head, neck, chest, abdomen and pelvis.
- You will have an MRI scan of the head and neck.
- You will have a PET/CT scan.
- You will be asked about any symptoms you may be having.
- Blood (about 2 teaspoons) will be drawn for routine tests.
This is an investigational study. Radiation and CHOP are FDA approved and commercially
available for patients with stage 1 and/or 2 NK cell lymphoma. The collection of long term
information about this treatment is investigational.
Up to 40 patients will take part in this study. All will be enrolled at MD Anderson.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Progression-free survival (PFS)
Progression-free survival (PFS) defined as time from treatment initiation day to first documented progressive disease or death due to disease. Reviewed with each 21-day treatment cycle, followed every 3-4 months for first 2 years, annually thereafter.
Day 1 to disease progression or death (up to 5+ years)
Yes
Bouthaina Dabaja, MD
Principal Investigator
UT MD Anderson Cancer Center
United States: Food and Drug Administration
2010-0035
NCT01321008
May 2011
Name | Location |
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UT MD Anderson Cancer Center | Houston, Texas 77030 |