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Last Modified: 10/8/2008     First Published: 10/25/2004  
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Radiation Therapy and Stereotactic Radiosurgery With or Without Temozolomide or Erlotinib in Treating Patients With Brain Metastases Secondary to Non-Small Cell Lung Cancer

Alternate Title
Basic Trial Information
Trial Description
     Purpose
     Eligibility
     Treatment/Intervention
Trial Contact Information
Registry Information

Alternate Title

Phase III Randomized Study of Whole Brain Radiotherapy and Stereotactic Radiosurgery With Versus Without Temozolomide or Erlotinib in Patients With Non-Small Cell Lung Cancer and Brain Metastases

Basic Trial Information

Phase
Type
Status
Age
Sponsor
Protocol IDs

Phase III


Treatment


Active


18 and over


NCI


RTOG-0320
RTOG-0320, NCT00096265

Trial Description

Purpose:

Radiation therapy uses high-energy x-rays to kill tumor cells. Stereotactic radiosurgery may be able to deliver x-rays directly to the tumor and cause less damage to normal tissue. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop tumor cells from dividing so they stop growing or die. Erlotinib may stop the growth of tumor cells by blocking the enzymes necessary for their growth and by blocking blood flow to the tumor. It is not yet known whether radiation therapy and stereotactic radiosurgery are more effective with or without temozolomide or erlotinib in treating brain metastases.

This randomized phase III trial is studying whole-brain radiation therapy and stereotactic radiosurgery with or without temozolomide or erlotinib to see how well they work compared to whole-brain radiation therapy and stereotactic radiosurgery in treating patients with brain metastases secondary to non-small cell lung cancer.

Eligibility:

Eligibility criteria include the following:

Final eligibility for a clinical trial is determined by the health professionals conducting the trial.

Treatment/Intervention:

Patients will be randomly assigned to one of three groups.

Patients in group one will undergo radiation therapy to the whole brain once a day, 5 days a week, for 3 weeks. They will undergo stereotactic radiosurgery within 2 weeks after completing whole brain radiation therapy.

Patients in group two will undergo radiation therapy to the whole brain and stereotactic radiosurgery as in group one. Beginning on the first day of whole-brain radiation therapy, they will receive temozolomide by mouth once a day for 3 weeks. Four weeks after completing whole-brain radiation therapy, patients will receive temozolomide by mouth once a day for 5 days. Treatment with temozolomide may be repeated every 4 weeks for up to six courses.

Patients in group three will undergo radiation therapy to the whole brain and stereotactic radiosurgery as in group one. Beginning on the first day of whole-brain radiation therapy, they will receive erlotinib by mouth once a day for up to 6 months.

All patients may undergo additional stereotactic radiosurgery. Quality of life will be assessed periodically. Patients will be evaluated every 3 months for 2 years, every 6 months for 2 years, and once a year thereafter.

Important:

For more details about this trial, refer to the Health Professional version of the trial summary.

If you are interested in participating in a clinical trial, contact your doctor for a referral or call a trial contact person listed below. You may see the same contact person listed at more than one site, however, if you call the number listed you can ask to speak to the study coordinator or person involved with the specific trial you are interested in. If you have questions about cancer or clinical trials, call the Cancer Information Service at 1-800-4-CANCER (1-800-422-6237). General information about clinical trials, including risks, benefits, and costs, can be found on NCI's Web site.

Trial Contact Information

Trial Lead Organizations

Radiation Therapy Oncology Group

Paul Sperduto, MD, Protocol chair
Ph: 952-442-6000
Email: psperduto@mropa.com
Minesh Mehta, MD, Protocol co-chair
Ph: 608-263-5009; 800-622-8922
Email: mehta@humonc.wisc.edu
H. Robins, MD, PhD, Protocol co-chair
Ph: 608-263-1416; 800-622-8922
Email: hirobins@facstaff.wisc.edu

Trial Sites

U.S.A.
California
  Burbank
 Providence Saint Joseph Medical Center - Burbank
 Clinical Trials Office - Providence Saint Joseph Medical Center - Burbank
Ph: 818-847-3220
  Los Angeles
 Kaiser Permanente Medical Center - Los Angeles
 Michael Girvigian
Ph: 323-667-4011
800-954-8000
  Pomona
 Robert and Beverly Lewis Family Cancer Care Center at Pomona Valley Hospital Medical Center
 Clinical Trials Office - Robert and Beverly Lewis Family Cancer Care Center
Ph: 909-865-9555
Colorado
  Grand Junction
 St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center
 Douglas Rock, MD
Ph: 970-244-2442
Florida
  Jacksonville
 Baptist Cancer Institute - Jacksonville
 Clinical Trials Office - Baptist Cancer Institute - Jacksonville
Ph: 904-202-7051
 Integrated Community Oncology Network at Southside Cancer Center
 Douglas Johnson, MD
Ph: 904-202-7020
  Jacksonville Beach
 Integrated Community Oncology Network
 Douglas Johnson, MD
Ph: 904-202-7020
  Jascksonville
 Baptist Medical Center South
 Douglas Johnson, MD
Ph: 904-202-7020
  Orange Park
 Integrated Community Oncology Network - Orange Park
 Douglas Johnson, MD
Ph: 904-202-7020
  Orlando
 M.D. Anderson Cancer Center at Orlando
 Alan Forbes, MD, PhD
Ph: 407-648-3800
800-648-3818
  Palatka
 Florida Cancer Center - Palatka
 Douglas Johnson, MD
Ph: 904-202-7020
  Panama City
 Bay Medical
 R. Charles Nichols, MD
Ph: 850-763-0036
  Saint Augustine
 Flagler Cancer Center
 Douglas Johnson, MD
Ph: 904-202-7020
  Tallahassee
 Tallahassee Memorial Hospital
 Timothy Bolek, MD
Ph: 850-431-5255
Georgia
  Columbus
 John B. Amos Cancer Center
 Clinical Trials Office - John B. Amos Cancer Center
Ph: 706-660-6404
Idaho
  Boise
 Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center
 Clinical Trials Office - Saint Alphonsus Cancer Care Center
Ph: 208-367-7954
Illinois
  Arlington Heights
 Northwest Community Hospital
 Stephen Nigh, MD
Ph: 847-618-6560
  Chicago
 Robert H. Lurie Comprehensive Cancer Center at Northwestern University
 Clinical Trials Office - Robert H. Lurie Comprehensive Cancer Center at Northwestern University
Ph: 312-695-1301
 Email: cancer@northwestern.edu
  Springfield
 Cancer Institute at St. John's Hospital
 Bruce Shevlin, MD
Ph: 217-525-5666
800-524-0575
Indiana
  Fort Wayne
 Parkview Regional Cancer Center at Parkview Health
 David Hornback, MD
Ph: 574-647-7461
  Hammond
 Oncology Center at Saint Margaret Mercy Healthcare Center
 Urmi Kalokhe, MD
Ph: 219-933-2130
  Indianapolis
 Methodist Cancer Center at Methodist Hospital
 Alexander Yeh, MD
Ph: 317-962-8288
800-265-3220
Maryland
  Baltimore
 Greenebaum Cancer Center at University of Maryland Medical Center
 Clinical Trials Office - Greenebaum Cancer Center at University of Maryladn Medical Center
Ph: 800-888-8823
 St. Agnes Hospital Cancer Center
 Richard Hudes, MD
Ph: 410-368-2910
Michigan
  Ann Arbor
 University of Michigan Comprehensive Cancer Center
 Clinical Trials Office - University of Michigan Comprehensive Cancer Center
Ph: 800-865-1125
  Detroit
 Barbara Ann Karmanos Cancer Institute
 Clinical Trials Office - Barbara Ann Karmanos Cancer Institute
Ph: 313-576-9363
  Kalamazoo
 West Michigan Cancer Center
 Clinical Trials Office - West Michigan Cancer Center
Ph: 269-373-7458
Minnesota
  Burnsville
 Fairview Ridges Hospital
 Paul Sperduto, MD
Ph: 952-892-2000
  Coon Rapids
 Mercy and Unity Cancer Center at Mercy Hospital
 Paul Sperduto, MD
Ph: 763-236-6000
  Edina
 Fairview Southdale Hospital
 Clinical Trials Office - Fairview Southdale Hospital
Ph: 612-625-3650
  Fridley
 Mercy and Unity Cancer Center at Unity Hospital
 Paul Sperduto, MD
Ph: 763-236-5000
  Minneapolis
 Virginia Piper Cancer Institute at Abbott - Northwestern Hospital
 Clinical Trials Office - Virginia Piper Cancer Institute
Ph: 612-863-5654
  Robbinsdale
 Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center
 Clinical Trials Office - Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center
Ph: 763-520-1893
  Saint Cloud
 CentraCare Clinic - River Campus
 Barbi Kaplan-Frenkel, DO
Ph: 320-252-5131
 Coborn Cancer Center
 Barbi Kaplan-Frenkel, DO
Ph: 320-229-4907
877-229-4907
  Saint Louis Park
 CCOP - Metro-Minnesota
 Paul Sperduto, MD
Ph: 952-993-1517
 Park Nicollet Cancer Center
 Paul Sperduto, MD
Ph: 952-993-3248
  Saint Paul
 United Hospital
 Paul Sperduto, MD
Ph: 651-241-8000
  Waconia
 Ridgeview Medical Center
 Paul Sperduto, MD
Ph: 952-442-2191
800-967-4620
Missouri
  Saint Louis
 Saint Louis University Cancer Center
 Clinical Trials Office - Saint Louis University Cancer Center
Ph: 314-977-4440
Nevada
  Las Vegas
 CCOP - Nevada Cancer Research Foundation
 John Ellerton, MD, CM
Ph: 702-384-0013
  Reno
 Renown Institute for Cancer at Renown Regional Medical Center
 Lawrence Dardick, MD
Ph: 775-982-5638
New Jersey
  Red Bank
 Booker Cancer Center at Riverview Medical Center
 Adnan Danish
Ph: 732-530-2382
  Sparta
 Frederick R. and Betty M. Smith Cancer Treatment Center
 Maria Werner-Wasik, MD
Ph: 215-955-7679
New York
  Rochester
 James P. Wilmot Cancer Center at University of Rochester Medical Center
 Paul Okunieff, MD
Ph: 585-275-5345
North Carolina
  Asheville
 Mission Hospitals - Memorial Campus
 Clinical Trials Office - Mission Hospitals - Memorial Campus
Ph: 828-213-4150
Ohio
  Akron
 Summa Center for Cancer Care at Akron City Hospital
 Clinical Trials Office - Akron City Hospital
Ph: 330-375-6101
  Cleveland
 Cleveland Clinic Taussig Cancer Center
 Clinical Trials Office - Cleveland Clinic Taussig Cancer Center
Ph: 866-223-8100
Oklahoma
  Tulsa
 Natalie Warren Bryant Cancer Center at St. Francis Hospital
 Charles Stewart
Ph: 918-494-2273
Pennsylvania
  Drexel Hill
 Delaware County Regional Cancer Center at Delaware County Memorial Hospital
 Deborah Markiewicz, MD
Ph: 610-284-8240
  Philadelphia
 Fox Chase Cancer Center - Philadelphia
 Clinical Trials Office - Fox Chase Cancer Center - Philadelphia
Ph: 215-728-4790
 Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
 Clinical Trials Office - Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
Ph: 215-955-6084
  Reading
 McGlinn Family Regional Cancer Center at Reading Hospital and Medical Center
 Clinical Trials Office - McGlinn Family Regional Cancer Center
Ph: 610-988-9323
South Carolina
  Charleston
 Hollings Cancer Center at Medical University of South Carolina
 Clinical Trials Office - Hollings Cancer Center at Medical University of South Carolina
Ph: 843-792-9321
Tennessee
  Knoxville
 Thompson Cancer Survival Center
 Clinical Trials Office - Thompson Cancer Survival Center
Ph: 865-541-1812
Texas
  Dallas
 Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
 Clinical Trials Office - Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
Ph: 866-460-4673; 214-648-7097
  Galveston
 University of Texas Medical Branch
 Clinical Trials Office - University of Texas Medical Branch
Ph: 409-772-1950
  Houston
 M. D. Anderson Cancer Center at University of Texas
 Clinical Trials Office - M. D. Anderson Cancer Center at the University of Texas
Ph: 713-792-3245
Virginia
  Norfolk
 Sentara Cancer Institute at Sentara Norfolk General Hospital
 Clinical Trials Office - Sentara Cancer Institute at Sentara Norfolk General Hospital
Ph: 757-388-2406
Washington
  Seattle
 CCOP - Virginia Mason Research Center
 Huong Pham, MD
Ph: 206-223-6801
Wisconsin
  Madison
 University of Wisconsin Paul P. Carbone Comprehensive Cancer Center
 Clinical Trials Office - University of Wisconsin Paul P. Carbone Comprehensive Cancer Center
Ph: 608-262-5223
  Milwaukee
 Medical College of Wisconsin Cancer Center
 Clinical Trials Office - Medical College of Wisconsin Cancer Center
Ph: 414-805-4380
Canada
Ontario
  Ottawa
 Ottawa Hospital Regional Cancer Centre - General Campus
 Gad Perry
Ph: 613-737-7700 ext. 70209
888-627-5346
Quebec
  Montreal
 McGill Cancer Centre at McGill University
 David Roberge
Ph: 514-398-1444

Registry Information
Official Title 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
Trial Start Date 2004-10-06
Trial Completion Date 2009-12-24 (estimated)
Registered in ClinicalTrials.gov NCT00096265
Date Submitted to PDQ 2004-08-27
Information Last Verified 2008-10-08
NCI Grant/Contract Number CA21661

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