Combination Chemotherapy With or Without Peripheral Stem Cell Transplantation, Radiation Therapy, and/or Surgery in Treating Patients With Ewing's Sarcoma



Status:Recruiting
Conditions:Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:Any - 49
Updated:4/2/2016
Start Date:February 2001

Use our guide to learn which trials are right for you!

European Ewing Tumour Working Initiative of National Groups Ewing Tumour Studies 1999 (EURO-E.W.I.N.G.99)

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing
so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor
cells. Peripheral stem cell transplantation may allow the doctor to give higher doses of
chemotherapy and kill more tumor cells. It is not yet known if combination chemotherapy is
more effective with or without radiation therapy and/or surgery in treating Ewing's sarcoma.

PURPOSE: This randomized phase III trial is studying different combination chemotherapy
regimens to see how well they work when given with or without peripheral stem cell
transplantation, radiation therapy, and/or surgery in treating patients with Ewing's
sarcoma.

OBJECTIVES:

Primary

- Compare the event-free and overall survival of patients with tumor of the Ewing's
family treated with standard induction chemotherapy comprising vincristine,
dactinomycin, ifosfamide and etoposide (VIDE) followed by consolidation chemotherapy
comprising vincristine, dactinomycin, and ifosfamide versus high-dose busulfan and
melphalan (Bu-Mel) followed by autologous peripheral blood stem cell (PBSC)
transplantation with or without radiotherapy and/or surgery.

Secondary

- Determine the prognostic significance of EWS-Flil transcript in these patients.

- Determine the frequency and prognostic value of minimal disease in bone marrow and
PBSC, as determined by the presence or absence of EWS-Flil transcript, in these
patients.

- Determine the feasibility and toxicity of VIDE induction chemotherapy in these
patients.

- Determine the response of these patients to VIDE induction chemotherapy.

- Determine the feasibility and toxicity of VAI consolodation chemotherapy in these
patients.

- Determine the feasibility and toxicity of Bu-Mel consolodation chemotherapy in these
patients.

- Determine event-free survival and overall survival of patients treated with these
regimens by prognostic group analysis.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to age
and local treatment of the primary tumor (yes vs no).

Patients receive induction chemotherapy comprising vincristine IV on day 1 and ifosfamide IV
over 3 hours, doxorubicin IV over 4 hours, and etoposide IV over 1 hour on days 1-3 (VIDE).
Treatment repeats every 21 days for 4 courses in the absence of unacceptable toxicity.
Peripheral blood stem cells (PBSC) are collected after course 3 and/or 4. Patients are
evaluated after course 4. Patients in need of early radiotherapy due to an axial tumor or
patients who require radiotherapy to the brain and/or spinal cord (at any time during study)
are assigned to group 1. Patients not needing early radiotherapy are assigned to group 2.

- Group 1: Patients receive 2 additional courses of VIDE induction chemotherapy (courses
5 and 6). Patients requiring radiotherapy to the axial tumor also undergo concurrent
radiotherapy 5 days a week. Some patients may then undergo surgical resection of the
tumor. All patients will then receive vincristine IV on day 1 and dactinomycin IV and
ifosfamide IV over 3 hours on days 1 and 2 (VAI). Treatment repeats every 21 days for 8
courses (courses 7-14). Patients requiring radiotherapy to the brain and/or spinal cord
also undergo concurrent radiotherapy.

- Group 2: Patients undergo 2 additional courses of VIDE induction chemotherapy (courses
5 and 6). Some patients may then undergo surgical resection of the tumor. All patients
receive VAI chemotherapy as in group 1 for 1 course. Patients are randomized to 1 of 2
consolidation therapy arms.

- Arm I: Patients receive 7 additional courses of VAI chemotherapy (courses 8-14).
Patients with unresectable, partially resected, or inadequately resected disease
undergo concurrent whole-lung radiotherapy for 6-12 days.

- Arm II: Patients receive high-dose chemotherapy comprising oral busulfan every 6
hours on days -6 to -3 and melphalan IV over 30 minutes on day -2. Patients
receive autologous PBSC IV on day 0. Patients with unresectable, partially
resected, or inadequately resected disease undergo concurrent radiotherapy 5 days
a week for at least 5 weeks.

Patients are followed every 3 months for 4 years, every 6 months for 1 year, and then
periodically thereafter.

Peer Reviewed and Funded or Endorsed by Cancer Research UK

PROJECTED ACCRUAL: Approximately 1,200 patients will be accrued for this study within
approximately 7 years.

DISEASE CHARACTERISTICS:

- Histologically confirmed tumor of the Ewing's family of bone or soft tissue

- Ewing's sarcoma

- Peripheral primitive neuroectodermal tumor

- Disease meeting one of the following criteria:

- Resectable localized disease (tumor volume less than 200 mL)

- Localized disease previously resected at diagnosis

- Unresectable disease (at least 200 mL tumor volume) but radiotherapy as local
control can be delayed

- Localized disease with early radiotherapy required

- Pulmonary and/or pleural metastases only

- Extrapulmonary/pleural metastases (skeleton, bone marrow, lymph nodes)

- No more than 45 days since definitive biopsy

PATIENT CHARACTERISTICS:

Age:

- Under 50

Performance status:

- Not specified

Life expectancy:

- Not specified

Hematopoietic:

- Not specified

Hepatic:

- Not specified

Renal:

- Renal function normal

- Glomerular filtration rate at least 60 mL/min

Cardiovascular:

- Normal cardiac function

- Fractional shortening at least 29%

- Ejection fraction at least 40%

Other:

- No medical, psychiatric, or social condition that would preclude study participation

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- Not specified

Chemotherapy:

- No prior chemotherapy

Endocrine therapy:

- Not specified

Radiotherapy:

- Not specified

Surgery:

- See Disease Characteristics
We found this trial at
88
sites
1600 Divisadero Street
San Francisco, California 94115
888.689.8273
UCSF Helen Diller Family Comprehensive Cancer Center UCSF’s long tradition of excellence in cancer research...
?
mi
from
San Francisco, CA
Click here to add this to my saved trials
1405 Clifton Road Northeast
Atlanta, Georgia 30322
(404) 785-6000
AFLAC Cancer Center and Blood Disorders Service of Children's Healthcare of Atlanta - Egleston Campus...
?
mi
from
Atlanta, GA
Click here to add this to my saved trials
2401 West Belvedere Avenue
Baltimore, Maryland 21215
(410) 601-4688
Alvin and Lois Lapidus Cancer Institute at Sinai Hospital The Alvin & Lois Lapidus Cancer...
?
mi
from
Baltimore, MD
Click here to add this to my saved trials
2545 Schoenersville Rd
Bethlehem, Pennsylvania 18017
(484) 884-2200
Lehigh Valley Hospital - Muhlenberg At Lehigh Valley Health Network, we continually go the extra...
?
mi
from
Bethlehem, PA
Click here to add this to my saved trials
1802 6th Avenue South
Birmingham, Alabama 35294
(205) 934-4011
UAB Comprehensive Cancer Center One of the nation’s leading cancer research and treatment centers, the...
?
mi
from
Birmingham, AL
Click here to add this to my saved trials
1300 Morris Park Avenue
Bronx, New York 10461
718.430.2302
Albert Einstein Cancer Center at Albert Einstein College of Medicine The Albert Einstein Cancer Center...
?
mi
from
Bronx, NY
Click here to add this to my saved trials
666 Elm Street
Buffalo, New York 14263
(716) 845-2300
Roswell Park Cancer Institute Welcome to Roswell Park Cancer Institute (RPCI), America's first cancer center...
?
mi
from
Buffalo, NY
Click here to add this to my saved trials
1025 Morehead Medical Dr # 600
Charlotte, North Carolina 28204
(704) 355-2884
Blumenthal Cancer Center at Carolinas Medical Center As our patients wage their personal wars against...
?
mi
from
Charlotte, NC
Click here to add this to my saved trials
200 Hawthorne Lane
Charlotte, North Carolina 28233
704-384-4000
Presbyterian Cancer Center at Presbyterian Hospital At Novant Health Presbyterian Medical Center, we are welcoming...
?
mi
from
Charlotte, NC
Click here to add this to my saved trials
1300 Jefferson Park Avenue
Charlottesville, Virginia 22908
434-243-6784
University of Virginia Cancer Center We are fortunate in having state of the art clinical...
?
mi
from
Charlottesville, VA
Click here to add this to my saved trials
3333 Burnet Avenue # Mlc3008
Cincinnati, Ohio 45229
 1-513-636-4200 
Cincinnati Children's Hospital Medical Center Patients and families from across the region and around the...
?
mi
from
Cincinnati, OH
Click here to add this to my saved trials
11100 Euclid Avenue
Cleveland, Ohio 44106
(216) 844-1000
Rainbow Babies and Children's Hospital UH Rainbow Babies & Children’s Hospital is a 244-bed, full-service...
?
mi
from
Cleveland, OH
Click here to add this to my saved trials
2010 E 90th St
Cleveland, Ohio 44195
(866) 223-8100
Cleveland Clinic Taussig Cancer Center At Taussig Cancer Institute, more than 250 highly skilled doctors,...
?
mi
from
Cleveland, OH
Click here to add this to my saved trials
700 Childrens Drive
Columbus, Ohio 43205
(616) 722-2000
Nationwide Children's Hospital At Nationwide Children’s, we are creating the future of pediatric health care....
?
mi
from
Columbus, OH
Click here to add this to my saved trials
3533 South Alameda Street
Corpus Christi, Texas 78411
(361) 694-5000
Driscoll Children's Hospital Driscoll Children's Hospital was built because Clara Driscoll's will requested that a...
?
mi
from
Corpus Christi, TX
Click here to add this to my saved trials
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas From its...
?
mi
from
Dallas, TX
Click here to add this to my saved trials
1500 E Duarte Rd
Duarte, California 91010
(626) 256-4673
City of Hope Comprehensive Cancer Center City of Hope is a leading research and treatment...
?
mi
from
Duarte, CA
Click here to add this to my saved trials
3300 Gallows Road
Falls Church, Virginia 22042
(703) 776-4001
Inova Fairfax Hospital Inova Fairfax Hospital, Inova's flagship hospital, is an 833-bed, nationally recognized regional...
?
mi
from
Falls Church, VA
Click here to add this to my saved trials
1 Hurley Plaza
Flint, Michigan 48503
(810) 262-9000
Hurley Medical Center From its founding in 1908, Hurley Medical Center has devoted itself to...
?
mi
from
Flint, MI
Click here to add this to my saved trials
100 Michigan Street Northeast
Grand Rapids, Michigan 49503
616.391.9000
Helen DeVos Children's Hospital at Spectrum Health Helen DeVos Children's Hospital, located in Grand Rapids,...
?
mi
from
Grand Rapids, MI
Click here to add this to my saved trials
1920 Libal Street
Green Bay, Wisconsin 54307
(920) 433-8889
St. Vincent Hospital Regional Cancer Center Our group of 19 oncologists, including the region's only...
?
mi
from
Green Bay, WI
Click here to add this to my saved trials
600 Moye Boulevard
Greenville, North Carolina 27834
?
mi
from
Greenville, NC
Click here to add this to my saved trials
701 Grove Rd # 1
Greenville, South Carolina 29605
(864) 455-7000
Greenville Hospital Cancer Center Greenville Health System (GHS) is a public not-for-profit academic healthcare delivery...
?
mi
from
Greenville, SC
Click here to add this to my saved trials
19229 Mack Ave
Grosse Pointe Woods, Michigan 48236
(866) 246-4673
Van Elslander Cancer Center at St. John Hospital and Medical Center We built the Van...
?
mi
from
Grosse Pointe Woods, MI
Click here to add this to my saved trials
30 Prospect Avenue
Hackensack, New Jersey 07601
(201) 996-5900
Hackensack University Medical Center Cancer Center The mission of the John Theurer Cancer Center is...
?
mi
from
Hackensack, NJ
Click here to add this to my saved trials
701 Ilalo Street Suite 600
Honolulu, Hawaii 96813
808-586-3010
Cancer Research Center of Hawaii The University of Hawaii Cancer Center is the only National...
?
mi
from
Honolulu, HI
Click here to add this to my saved trials
200 Hawkins Drive
Iowa City, Iowa 52242
800-237-1225
Holden Comprehensive Cancer Center at University of Iowa Holden Comprehensive Cancer Center is dedicated to...
?
mi
from
Iowa City, IA
Click here to add this to my saved trials
2500 N. State St.
Jackson, Mississippi 39216
(601) 815-6802
University of Mississippi Cancer Clinic he Cancer Institute is home to the ACT Tobacco Treatment,...
?
mi
from
Jackson, MS
Click here to add this to my saved trials
807 Childrens Way
Jacksonville, Florida 32207
(904) 697-3600
Nemours Children's Clinic At Nemours Children’s Clinic, Jacksonville, we've treated every child as we would...
?
mi
from
Jacksonville, FL
Click here to add this to my saved trials
524 South Park Street
Kalamazoo, Michigan 49007
(269) 341-7654
Bronson Methodist Hospital Our healthcare system serves patients and families throughout southwest Michigan and northern...
?
mi
from
Kalamazoo, MI
Click here to add this to my saved trials
2401 Gillham Rd
Kansas City, Missouri 64108
(816) 234-3000
Children's Mercy Hospital Children's Mercy Hospitals and Clinics continues redefining pediatric medicine throughout the Midwest...
?
mi
from
Kansas City, MO
Click here to add this to my saved trials
401 W Greenlawn Ave
Lansing, Michigan 48910
?
mi
from
Lansing, MI
Click here to add this to my saved trials
4650 Sunset Blvd
Los Angeles, California 90027
 (323) 660-2450
Childrens Hospital Los Angeles Children's Hospital Los Angeles is a 501(c)(3) nonprofit hospital for pediatric...
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
231 E Chestnut St
Louisville, Kentucky 40202
(502) 629-6000
Kosair Children's Hospital For more than a century, Kosair Children's Hospital and its predecessor hospitals...
?
mi
from
Louisville, KY
Click here to add this to my saved trials
425 E River Pkwy # 754
Minneapolis, Minnesota 55455
612-624-2620
Masonic Cancer Center at University of Minnesota The Masonic Cancer Center was founded in 1991....
?
mi
from
Minneapolis, MN
Click here to add this to my saved trials
701 West 168th Street
New York, New York 10032
(212) 851-4680
Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center The Herbert Irving Comprehensive Cancer...
?
mi
from
New York, NY
Click here to add this to my saved trials
601 Children's Lane
Norfolk, Virginia 23507
(757) 668-7000
Children's Hospital of The King's Daughters Children
?
mi
from
Norfolk, VA
Click here to add this to my saved trials
800 NE 10th Street
Oklahoma City, Oklahoma 73104
(855) 750-2273
Oklahoma University Cancer Institute The Peggy and Charles Stephenson Cancer Center is located on the...
?
mi
from
Oklahoma City, OK
Click here to add this to my saved trials
1717 South Orange Avenue # 100
Orlando, Florida 32806
(407) 650-7000
Nemours Children's Clinic - Orlando Located near downtown Orlando, Nemours Children’s Clinic, Orlando is a...
?
mi
from
Orlando, FL
Click here to add this to my saved trials
5153 North 9th Avenue
Pensacola, Florida 32504
(850) 505-4700
Nemours Children's Clinic - Pensacola Nemours Children’s Clinic, Pensacola serves children and families in northwest...
?
mi
from
Pensacola, FL
Click here to add this to my saved trials
530 Northeast Glen Oak Avenue
Peoria, Illinois 61603
(309) 624-4945
Saint Jude Midwest Affiliate The Jim and Trudy Maloof St. Jude Midwest Affiliate Clinic was...
?
mi
from
Peoria, IL
Click here to add this to my saved trials
South 34th Street
Philadelphia, Pennsylvania 19104
 215-590-1000
Children's Hospital of Philadelphia Since its start in 1855 as the nation's first hospital devoted...
?
mi
from
Philadelphia, PA
Click here to add this to my saved trials
4401 Penn Avenue
Pittsburgh, Pennsylvania 15224
412-692-5325
Children's Hospital of Pittsburgh of UPMC UPMC is one of the leading nonprofit health systems...
?
mi
from
Pittsburgh, PA
Click here to add this to my saved trials
601 Elmwood Avenue
Rochester, New York 14642
(585) 275-5830
James P. Wilmot Cancer Center at University of Rochester Medical Center The Wilmot Cancer Center...
?
mi
from
Rochester, NY
Click here to add this to my saved trials
280 W MacArthur Blvd,
Sacramento, California 94611
(510) 752-1000
Kaiser Permanente Medical Center - Oakland The East Bay area, home of the flagship Oakland...
?
mi
from
Sacramento, CA
Click here to add this to my saved trials
100 N Mario Capecchi Dr
Salt Lake City, Utah 84132
(801) 662-1000
?
mi
from
Salt Lake City, UT
Click here to add this to my saved trials
7700 Floyd Curl Dr
San Antonio, Texas 78229
(210) 575-7000
Methodist Children's Hospital of South Texas Methodist Children
?
mi
from
San Antonio, TX
Click here to add this to my saved trials
4502 Medical Drive
San Antonio, Texas 78284
(210) 567-7000
University of Texas Health Science Center at San Antonio The University of Texas Health Science...
?
mi
from
San Antonio, TX
Click here to add this to my saved trials
3020 Childrens way
San Diego, California 92123
(858) 576-1700
Rady Children's Hospital - San Diego Rady Children's Hospital-San Diego is the region’s pediatric medical...
?
mi
from
San Diego, CA
Click here to add this to my saved trials
3900 W Avera Drive
Sioux Falls, South Dakota 57108
(605) 322-4700
Avera Cancer Institute Avera, the health ministry of the Benedictine and Presentation Sisters, is a...
?
mi
from
Sioux Falls, SD
Click here to add this to my saved trials
105 West 8th Avenue
Spokane, Washington 99220
(509) 474-3131
Providence Cancer Center at Sacred Heart Medical Center When Mother Joseph and the Sisters of...
?
mi
from
Spokane, WA
Click here to add this to my saved trials
345 Smith Ave N # 302
St. Paul, Minnesota 55102
?
mi
from
St. Paul, MN
Click here to add this to my saved trials
750 E Adams St
Syracuse, New York 13210
(315) 464-5540
SUNY Upstate Medical University Hospital SUNY Upstate Medical University in Syracuse, NY, is the only...
?
mi
from
Syracuse, NY
Click here to add this to my saved trials
3001 W Dr Martin L King Jr
Tampa, Florida 33607
(813) 870-4123
St. Joseph's Cancer Institute at St. Joseph's Hospital St. Joseph's Hospital is known for its...
?
mi
from
Tampa, FL
Click here to add this to my saved trials
901 45th Street
West Palm Beach, Florida 33407
?
mi
from
West Palm Beach, FL
Click here to add this to my saved trials
1600 Rockland Road
Wilmington, Delaware 19803
(302) 651-4200
Alfred I. duPont Hospital for Children Nemours began more than 70 years ago with the...
?
mi
from
Wilmington, DE
Click here to add this to my saved trials
Youngstown, Ohio 44501
?
mi
from
Youngstown, OH
Click here to add this to my saved trials
?
mi
from
Amarillo, TX
Click here to add this to my saved trials
?
mi
from
Aurora, CO
Click here to add this to my saved trials
?
mi
from
Boise, ID
Click here to add this to my saved trials
?
mi
from
Boston, MA
Click here to add this to my saved trials
3110 MacCorkle Ave. S.E.
Charleston, West Virginia 25304
304-347-1206
West Virginia University Health Sciences Center - Charleston The West Virginia University Robert C. Byrd...
?
mi
from
Charleston, WV
Click here to add this to my saved trials
?
mi
from
Chicago, IL
Click here to add this to my saved trials
1 Childrens Plaza
Dayton, Ohio 45404
(937) 641-3000
Dayton Children's - Dayton We have more than 290,000 reasons to make sure the care...
?
mi
from
Dayton, OH
Click here to add this to my saved trials
400 E Third Street
Duluth, Minnesota 55805
(218) 786-3868
CCOP - Duluth The Duluth CCOP, established and funded by the National Cancer Institute (NCI)...
?
mi
from
Duluth, MN
Click here to add this to my saved trials
20 Duke Clinic Cir
Durham, North Carolina 27710
(888) 275-3853
Duke Cancer Institute Leading-edge cancer care and research have been a hallmark of Duke Medicine...
?
mi
from
Durham, NC
Click here to add this to my saved trials
?
mi
from
Fort Worth, TX
Click here to add this to my saved trials
Hershey, Pennsylvania 17033
?
mi
from
Hershey, PA
Click here to add this to my saved trials
2018 W Clinch Ave
Knoxville, Tennessee 37916
(865) 541-8000
East Tennessee Children's Hospital East Tennessee Children's Hospital is a not-for-profit, private, independent pediatric medical...
?
mi
from
Knoxville, TN
Click here to add this to my saved trials
?
mi
from
Las Vegas, NV
Click here to add this to my saved trials
4018 W Capitol Ave.
Little Rock, Arkansas 72205
(501) 296-1200
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences The Winthrop P. Rockefeller...
?
mi
from
Little Rock, AR
Click here to add this to my saved trials
Los Angeles, California 90027
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
1000 N Oak Ave
Marshfield, Wisconsin 54449
(715) 387-5511
Marshfield Clinic - Marshfield Center The Clinic was incorporated under Wisconsin law in 1916 and...
?
mi
from
Marshfield, WI
Click here to add this to my saved trials
?
mi
from
Miami, FL
Click here to add this to my saved trials
9000 W Wisconsin Ave
Milwaukee, Wisconsin 53226
(414) 266-2000
Midwest Children's Cancer Center at Children's Hospital of Wisconsin We are the region's only independent...
?
mi
from
Milwaukee, WI
Click here to add this to my saved trials
2525 Chicago Ave
Minneapolis, Minnesota 55404
(612) 813-6000
Children's Hospitals and Clinics of Minnesota - Minneapolis Children's Hospitals and Clinics of Minnesota is...
?
mi
from
Minneapolis, MN
Click here to add this to my saved trials
New Orleans, Louisiana 70118
?
mi
from
New Orleans, LA
Click here to add this to my saved trials
?
mi
from
Palo Alto, CA
Click here to add this to my saved trials
1919 E Thomas Rd
Phoenix, Arizona 85006
(602) 933-1000
Phoenix Children's Hospital Phoenix Children's Hospital has provided hope, healing, and the best healthcare for...
?
mi
from
Phoenix, AZ
Click here to add this to my saved trials
2801 N Gantenbein Ave
Portland, Oregon 97227
(503) 276-6500
Legacy Emanuel Children's Hospital For generations our children's hospital has provided outstanding care for kids...
?
mi
from
Portland, OR
Click here to add this to my saved trials
200 First Street SW
Rochester, Minnesota 55905
507-284-2511
Mayo Clinic Cancer Center The Mayo Clinic Cancer Center is a National Cancer Institute-designated comprehensive...
?
mi
from
Rochester, MN
Click here to add this to my saved trials
Saint Petersburg, Florida 33701
?
mi
from
Saint Petersburg, FL
Click here to add this to my saved trials
?
mi
from
Seattle, WA
Click here to add this to my saved trials
315 West Carpenter Street
Springfield, Illinois 62794
217.545.8000
Simmons Cooper Cancer Institute Simmons Cancer Institute at SIU practices "the team approach" to cancer...
?
mi
from
Springfield, IL
Click here to add this to my saved trials
?
mi
from
St. Louis, MO
Click here to add this to my saved trials
?
mi
from
Tacoma, WA
Click here to add this to my saved trials
2142 N Cove Blvd
Toledo, Ohio 43606
(419) 291-4000
Toledo Hospital ProMedica’s Mission is to improve your health and well-being. And we at ProMedica...
?
mi
from
Toledo, OH
Click here to add this to my saved trials
111 Michigan Ave NW
Washington, District of Columbia
(202) 476-5000
Childrens National Medical Center As the nation’s children’s hospital, the mission of Children’s National Medical...
?
mi
from
Washington,
Click here to add this to my saved trials