A Phase III Trial Comparing Whole Brain Radiation And Stereotactic Radiosurgery Alone Versus With Temozolomide Or Erlotinib In Patients With Non-Small Cell Lung Cancer And 1-3 Brain Metastases
PRIMARY OBJECTIVES:
I. Compare survival in patients with non-small cell lung cancer and brain metastases treated
with whole brain radiotherapy and stereotactic radiosurgery with vs without temozolomide or
erlotinib.
SECONDARY OBJECTIVES:
I. Compare time to CNS progression in patients treated with these regimens. II. Compare
quality-adjusted survival in patients treated with these regimens. III. Compare 3-month
quality of life in patients treated with these regimens. IV. Compare the 6-month performance
status of patients treated with these regimens.
V. Compare 6-month steroid dependence in patients treated with these regimens. VI. Compare
cause of death (neurologic vs other) in patients treated with these regimens.
VII. Determine the effects of non-protocol chemotherapy in these patients.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to age
and the presence of extracranial metastases (< 65 years old AND no extracranial metastases
vs ≥ 65 years old OR extracranial metastases), number of metastases (1 vs 2 or 3), and
extent of extracranial disease (none vs present). Patients are randomized to 1 of 3
treatment arms.
ARM I: Patients undergo whole brain radiotherapy (WBRT) once daily on days 1-5, 8-12, and
15-19. Within 14 days after completion of WBRT, patients undergo stereotactic radiosurgery.
ARM II: Patients undergo WBRT and stereotactic radiosurgery as in arm I. Beginning on the
first day of WBRT, patients receive oral temozolomide once daily on days 1-21. Beginning 4
weeks after completion of WBRT, patients may receive oral temozolomide alone once daily on
days 1-5. Treatment with temozolomide repeats every 28 days for up to 6 courses in the
absence of disease progression or unacceptable toxicity.
ARM III: Patients undergo WBRT and stereotactic radiosurgery as in arm I. Beginning on the
first day of WBRT, patients receive oral erlotinib once daily for up to 6 months.
In all arms, patients with recurrent brain metastases may undergo additional stereotactic
radiosurgery.
Quality of life is assessed at baseline and at 3, 6, 9, 12, 18, and 24 months.
Patients are followed every 3 months for 2 years, every 6 months for 2 years, and then
annually thereafter.
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Overall Survival
Survival time is defined as time from randomization to date of death from any cause and estimated by the Kaplan-Meier method. Patients last known to be alive are censored at date of last contact.
From randomizaton to date of death for last follow-up. Analysis occurs after all patients have been potentiall followed for 9 months.
No
Paul Sperduto
Principal Investigator
American College of Radiology Imaging Network
United States: Food and Drug Administration
NCI-2009-00720
NCT00096265
October 2004
Name | Location |
---|---|
Akron City Hospital | Akron, Ohio 44304 |
Cleveland Clinic Foundation | Cleveland, Ohio 44195 |
Fox Chase Cancer Center | Philadelphia, Pennsylvania 19111 |
West Michigan Cancer Center | Kalamazoo, Michigan 49007-3731 |
Fairview Ridges Hospital | Burnsville, Minnesota 55337 |
United Hospital | St. Paul, Minnesota 55102 |
Ridgeview Medical Center | Waconia, Minnesota 55387 |
Massachusetts General Hospital Cancer Center | Boston, Massachusetts 02114 |
Northwest Community Hospital | Arlington Heights, Illinois 60005 |
Delaware County Memorial Hospital | Drexel Hill, Pennsylvania 19026 |
LDS Hospital | Salt Lake City, Utah 84143 |
Tallahassee Memorial Healthcare | Tallahassee, Florida 32308 |
University of Wisconsin Hospital and Clinics | Madison, Wisconsin 53792-0001 |
Thompson Cancer Survival Center | Knoxville, Tennessee 37916 |
McKay-Dee Hospital Center | Ogden, Utah 84403 |
Mercy Hospital | Coon Rapids, Minnesota 55433 |
Fairview-Southdale Hospital | Edina, Minnesota 55435 |
Abbott-Northwestern Hospital | Minneapolis, Minnesota 55407 |
Pomona Valley Hospital Medical Center | Pomona, California 91767 |
Northwestern University | Chicago, Illinois 60611 |
Saint Louis University Hospital | St. Louis, Missouri 63110-0250 |
University of Rochester | Rochester, New York 14642 |
Wayne State University | Detroit, Michigan 48202 |
University of Texas Southwestern Medical Center | Dallas, Texas |
Virginia Mason CCOP | Seattle, Washington 98101 |
Huntsman Cancer Institute/University of Utah | Salt Lake City, Utah 84112 |
Metro-Minnesota CCOP | St. Louis Park, Minnesota |
Thomas Jefferson University Hospital | Philadelphia, Pennsylvania 19131 |
Providence Saint Joseph Medical Center | Burbank, California 91505-4866 |
Saint Mary's Hospital and Regional Medical Center | Grand Junction, Colorado 81502 |
Edna Williams Cancer Center at the Baptist Cancer Institute | Jacksonville, Florida 32207 |
M D Anderson Cancer Center- Orlando | Orlando, Florida 32806 |
John B Amos Cancer Center | Columbus, Georgia 31904 |
Unity Hospital | Fridley, Minnesota 55432 |
North Memorial Medical Health Center | Robbinsdale, Minnesota 55422 |
Park Nicollet Clinic - Saint Louis Park | Saint Louis Park, Minnesota 55416 |
Nevada Cancer Research Foundation CCOP | Las Vegas, Nevada 89106 |
Sparta Cancer Treatment Center | Sparta, New Jersey 07871 |
Mission Hospitals Inc | Asheville, North Carolina 28801 |
University of Maryland Greenebaum Cancer Center | Baltimore, Maryland 21201 |
Intermountain Medical Center | Murray, Utah 84157 |
University of Minnesota Medical Center-Fairview | Minneapolis, Minnesota 55455 |
UMDNJ - Robert Wood Johnson University Hospital | New Brunswick, New Jersey 08903 |
Christiana Care Health System-Christiana Hospital | Newark, Delaware 19718 |
Riverview Medical Center/Booker Cancer Center | Red Bank, New Jersey 07701 |
Cancer Specialists of North Florida-Southside | Jacksonville, Florida 32207 |
Cancer Specialists of North Florida-Beaches | Jacksonville Beach, Florida 32250 |
Cancer Specialists of North Florida-Baptist South | Jascksonville, Florida 32258 |
Cancer Specialists of North Florida-Orange Park | Orange Park, Florida 32073 |
Cancer Specialists of North Florida-Putnam | Palatka, Florida 32177 |
Cancer Specialists of North Florida-Saint Augustine | Saint Augustine, Florida 32086 |
Saint Margaret Mercy Healthcare Centers- North Campus | Hammond, Indiana 46320 |
IU Health Methodist Hospital | Indianapolis, Indiana 46202 |
Sentara Hospitals | Norfolk, Virginia 23507 |