Know Cancer

forgot password

Primary Surgical Therapy for Biologically Defined Low-Risk Neuroblastoma: A Pediatric Oncology Group/Children's Cancer Group Intergroup Study

Phase 3
21 Years
Not Enrolling

Thank you

Trial Information

Primary Surgical Therapy for Biologically Defined Low-Risk Neuroblastoma: A Pediatric Oncology Group/Children's Cancer Group Intergroup Study


- To determine if asymptomatic patients with low-risk neuroblastoma treated with surgery
alone will have a 3-year survival rate of 95%.

- Estimate the response and 3-year event-free survival rates of symptomatic patients
treated with chemotherapy.

- Estimate the event-free survival and overall survival rates in patients who relapse or
progress after initial treatment with surgery alone.

- Determine the acute and chronic toxic effects associated with treating low-risk
neuroblastoma with surgery alone or surgery and chemotherapy.

OUTLINE: This is a multicenter study. Patients are stratified according to disease stage,
MYCN status, age, and histology.

Patients undergo primary tumor resection and biopsy of regional nodes. Patients with at
least 50% of the tumor resected are followed monthly for 3 months, every 3 months for 9
months, every 6 months for one year, and then annually thereafter.

Regimen I

- Patients with clinically symptomatic (e.g., respiratory distress, spinal cord
compromise with or without neurologic deficit, inferior vena cava compression with
renal or bowel ischemia, intractable vomiting due to gastrointestinal obstruction,
genitourinary obstruction, or coagulopathy) low-risk neuroblastoma or who have less
than 50% of the primary tumor resected receive 4 different courses of chemotherapy.

- Course 1: Patients receive carboplatin IV over 1 hour followed by etoposide IV over 2
hours on day 0 and etoposide only on days 1 and 2.

- Course 2: Patients receive carboplatin IV over 1 hour, cyclophosphamide IV over 1 hour,
and doxorubicin IV over 15-60 minutes on day 1.

- Course 3: Patients receive cyclophosphamide IV over 1 hour followed by etoposide IV
over 2 hours on day 0 and etoposide only on days 1 and 2.

- Course 4: Patients receive carboplatin IV over 1 hour and etoposide IV over 2 hours
followed by doxorubicin IV over 15-60 minutes on day 0 and etoposide only on days 1 and

Regimen II

- Patients who progress to or recur with unfavorable biology intermediate-risk disease
receive an additional 4 courses of chemotherapy.

- Course 5: Patients receive treatment as in course 3 above.

- Course 6: Patients receive treatment as in course 2 above.

- Course 7: Patients receive treatment as in course 1 above.

- Course 8: Patients receive cyclophosphamide IV over 1 hour followed by doxorubicin IV
over 15-60 minutes on day 1.

All infants under 60 days of age receive filgrastim (G-CSF) or sargramostim (GM-CSF)
subcutaneously beginning 24 to 36 hours after chemotherapy and continuing until blood counts

Courses in both regimens repeat every 3 weeks in the absence of unacceptable toxicity.

Patients at risk for symptomatic spinal cord compression may also receive chemotherapy.
Patients experiencing progressive or recurrent disease after observation undergo repeat
surgery and/or chemotherapy as above. Patients with clinically symptomatic disease may also
undergo radiotherapy if response to chemotherapy is not rapid.

Patients are followed every 2 months for 1 year, every 3 months for 1 year, every 6 months
for 1 year, and then annually thereafter.

PROJECTED ACCRUAL: A total of 820 patients will be accrued for this study within 4 years.

Inclusion Criteria


- Histologically proven low-risk neuroblastoma (excluding ganglioneuroma)

- International Neuroblastoma Staging System (INSS) stage 1 in all patients

- INSS stage 2A or 2B in patients less than 365 days of age

- INSS stage 2A or 2B tumor with nonamplified MYCN with any Shimada histology in
patients ages 1 to 20 years

- INSS stage 2A or 2B tumor with amplified MYCN with Shimada favorable histology
in patients ages 1 to 20 years

- INSS stage 4S tumors with nonamplified MYCN, Shimada favorable histology, and a
DNA index not equal to 1 in patients less than 365 days of age

- Immediate chemotherapy allowed prior to biopsy for patients with intradural extension
and/or emergent paresis if biopsy performed within 96 hours

- Must have no abnormal organ function unless due to neuroblastoma

- Concurrent registration on companion biology study (protocol COG-ANBL00B1) or its



- Under 21

Performance status:

- Not specified

Life expectancy:

- Not specified


- Not specified


- Bilirubin less than 1.5 times normal

- SGOT or SGPT less than 2.5 times normal


- Creatinine less than 1.5 times normal


- Shortening fraction greater than 27% by echocardiogram OR

- Ejection fraction greater than 47% by radionuclide angiogram


Biologic therapy:

- No prior immunotherapy


- See Disease Characteristics

Endocrine therapy:

- No prior hormonal therapy


- No prior radiotherapy


- Prior surgery allowed


- No other prior therapy

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Douglas R. Strother, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Alberta Children's Hospital


United States: Federal Government

Study ID:




Start Date:

March 1998

Completion Date:

Related Keywords:

  • Neuroblastoma
  • localized resectable neuroblastoma
  • stage 4S neuroblastoma
  • Neuroblastoma



Baylor College of Medicine Houston, Texas  77030
Fred Hutchinson Cancer Research Center Seattle, Washington  98109
Memorial Sloan-Kettering Cancer Center New York, New York  10021
University of Texas - MD Anderson Cancer Center Houston, Texas  77030-4009
University of Michigan Comprehensive Cancer Center Ann Arbor, Michigan  48109-0752
Children's Hospital of Philadelphia Philadelphia, Pennsylvania  19104
Mayo Clinic Cancer Center Rochester, Minnesota  55905
Jonsson Comprehensive Cancer Center, UCLA Los Angeles, California  90095-1781
MBCCOP - Hawaii Honolulu, Hawaii  96813
University of Chicago Cancer Research Center Chicago, Illinois  60637
University of Mississippi Medical Center Jackson, Mississippi  39216-4505
Cancer Center of Albany Medical Center Albany, New York  12208
Duke Comprehensive Cancer Center Durham, North Carolina  27710
Tripler Army Medical Center Honolulu, Hawaii  96859-5000
Children's Hospital of Michigan Detroit, Michigan  48201
Hurley Medical Center Flint, Michigan  48503
Mount Sinai School of Medicine New York, New York  10029
Presbyterian Healthcare Charlotte, North Carolina  28233-3549
Rhode Island Hospital Providence, Rhode Island  02903
Medical City Dallas Hospital Dallas, Texas  75230
San Antonio Military Pediatric Cancer and Blood Disorders Center Lackland Air Force Base, Texas  78236-5300
University of Texas Health Science Center at San Antonio San Antonio, Texas  78284-7811
Midwest Children's Cancer Center Milwaukee, Wisconsin  53226
Yale Comprehensive Cancer Center New Haven, Connecticut  06520-8028
Presbyterian - St. Luke's Medical Center Denver, Colorado  80218
Van Elslander Cancer Center at St. John Hospital and Medical Center Grosse Pointe Woods, Michigan  48236
Bronson Methodist Hospital Kalamazoo, Michigan  49007
Geisinger Medical Center Danville, Pennsylvania  17822-0001
Penn State Cancer Institute at Milton S. Hershey Medical Center Hershey, Pennsylvania  17033-0850
Avera Cancer Institute Sioux Falls, South Dakota  57105
Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center La Crosse, Wisconsin  54601
University of Alabama at Birmingham Comprehensive Cancer Center Birmingham, Alabama  35294-3300
Comprehensive Cancer Center at Wake Forest University Winston-Salem, North Carolina  27157-1082
Cancer Center at the University of Virginia Charlottesville, Virginia  22908
Huntsman Cancer Institute Salt Lake City, Utah  84112
Marshfield Clinic Marshfield, Wisconsin  54449
David Grant Medical Center Travis Air Force Base, California  94535
Lutheran General Cancer Care Center Park Ridge, Illinois  60068
Newark Beth Israel Medical Center Newark, New Jersey  07112
New York Medical College Valhalla, New York  10595
University of Texas Medical Branch Galveston, Texas  77555-1329
Naval Medical Center, Portsmouth Portsmouth, Virginia  23708-2197
Deaconess Medical Center Spokane, Washington  99210-0248
St. Vincent Hospital Green Bay, Wisconsin  54307-3508
University of Wisconsin Comprehensive Cancer Center Madison, Wisconsin  53792
Chao Family Comprehensive Cancer Center at University of California Irvine Cancer Center Orange, California  92868
Rush University Medical Center Chicago, Illinois  60612-3824
Holden Comprehensive Cancer Center at University of Iowa Iowa City, Iowa  52242-1002
UMASS Memorial Cancer Center - University Campus Worcester, Massachusetts  01605-2982
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center Lebanon, New Hampshire  03756-0002
Long Island Cancer Center at Stony Brook University Hospital Stony Brook, New York  11790-7775
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill Chapel Hill, North Carolina  27599-7570
CCOP - Columbia River Oncology Program Portland, Oregon  97225
CCOP - Scott and White Hospital Temple, Texas  76508
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Baltimore, Maryland  21231-2410
CCOP - St. Vincent Hospital Cancer Center, Green Bay Green Bay, Wisconsin  54301
Cancer Research Center of Hawaii Honolulu, Hawaii  96813
Cleveland Clinic Taussig Cancer Center Cleveland, Ohio  44195
MBCCOP - LSU Health Sciences Center New Orleans, Louisiana  70112
Madigan Army Medical Center Tacoma, Washington  98431-5048
Sutter Cancer Center Sacramento, California  95816
Eastern Maine Medical Center Bangor, Maine  04401
CCOP - Oklahoma Tulsa, Oklahoma  74136
Children's Hospital Los Angeles Los Angeles, California  90027-0700
Children's Hospital of Orange County Orange, California  92668
Children's Hospital of Denver Denver, Colorado  80218
Children's National Medical Center Washington, District of Columbia  20010-2970
Children's Mercy Hospital Kansas City, Missouri  64108
St. Joseph's Hospital and Medical Center Paterson, New Jersey  07503
Children's Hospital of Pittsburgh Pittsburgh, Pennsylvania  15213
Children's Hospital and Regional Medical Center - Seattle Seattle, Washington  98105
Rebecca and John Moores UCSD Cancer Center La Jolla, California  92093-0658
University of California Davis Cancer Center Sacramento, California  95817
Kaiser Permanente Medical Center/Kaiser Foundation Hospital - San Diego San Diego, California  92120
Kaiser Permanente Medical Center - Santa Clara Santa Clara, California  95051-5386
Broward General Medical Center Fort Lauderdale, Florida  33316
Children's Hospital of Southwest Florida Fort Myers, Florida  33908
Joe DiMaggio Children's Hospital at Memorial Hollywood, Florida  33021
Nemours Children's Clinic Jacksonville, Florida  32207
Miami Children's Hospital Miami, Florida  33155-4069
Florida Hospital Cancer Institute Orlando, Florida  32804
Nemours Children's Clinic-Orlando Orlando, Florida  32806
Sacred Heart Children's Hospital Pensacola, Florida  32504
All Children's Hospital St. Petersburg, Florida  33701
St. Mary's Hospital West Palm Beach, Florida  33407
Children's Memorial Hospital - Chicago Chicago, Illinois  60614
Advocate Hope Children's Hospital Oak Lawn, Illinois  60453
Saint Jude Midwest Affiliate Peoria, Illinois  61637
Wesley Medical Center Wichita, Kansas  67214
Children's Hospital of New Orleans New Orleans, Louisiana  70118
Ochsner Clinic Foundation New Orleans, Louisiana  70121
Maine Children's Cancer Program Scarborough, Maine  04074-9308
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute Boston, Massachusetts  02115
Floating Hospital for Children Boston, Massachusetts  02111
Cardinal Glennon Children's Hospital Saint Louis, Missouri  63104
University of New Mexico Cancer Research and Treatment Center Albuquerque, New Mexico  87131
Schneider Children's Hospital New Hyde Park, New York  11042
St. Christopher's Hospital for Children Philadelphia, Pennsylvania  19134-1095
Children's Hospital of Greenville Hospital System Greenville, South Carolina  29605
St. Jude Children's Research Hospital Memphis, Tennessee  38105-2794
Cook Children's Medical Center - Fort Worth Fort Worth, Texas  76104
Inova Fairfax Hospital Falls Church, Virginia  22042-3300
Carilion Medical Center for Children Roanoke, Virginia  24029
West Virginia University Hospitals Morgantown, West Virginia  26506-9300
City of Hope Comprehensive Cancer Center Duarte, California  91010
UCSF Comprehensive Cancer Center San Francisco, California  94115
Albert Einstein Clinical Cancer Center Bronx, New York  10461
John Stoddard Cancer Center at Iowa Methodist Medical Center Des Moines, Iowa  50309
Phoenix Children's Hospital Phoenix, Arizona  85016-7710
Southern California Permanente Medical Group Downey, California  90242
Children's Hospital Central California Madera, California  93638-8762
Santa Barbara Cottage Hospital Santa Barbara, California  93102
Medical Center of Central Georgia Macon, Georgia  31201
Southern Illinois University School of Medicine Springfield, Illinois  62794-9658
Kosair Children's Hospital Louisville, Kentucky  40202-3830
Spectrum Health and DeVos Children's Hospital Grand Rapids, Michigan  49503
CCOP - Beaumont Royal Oak, Michigan  48073-6769
Children's Hospitals and Clinics - Minneapolis Minneapolis, Minnesota  55404
St. Louis Children's Hospital Saint Louis, Missouri  63110
Children's Hospital of Omaha Omaha, Nebraska  68114
Sunrise Hospital and Medical Center Las Vegas, Nevada  89109-2306
Brookdale University Hospital and Medical Center Brooklyn, New York  11212
Brooklyn Hospital Center Brooklyn, New York  11201
Children's Hospital Medical Center of Akron Akron, Ohio  44308
Children's Medical Center - Dayton Dayton, Ohio  45404
St. Vincent Mercy Medical Center Toledo, Ohio  43608
Toledo Children's Hospital Toledo, Ohio  43601
Forum Health-Tod Childrens Hospital Youngstown, Ohio  44501
Natalie Warren Bryant Cancer Center Tulsa, Oklahoma  74136
Palmetto Health South Carolina Cancer Center Columbia, South Carolina  29203
East Tennessee Children's Hospital Knoxville, Tennessee  37901
Texas Tech University Health Sciences Center School of Medicine Amarillo, Texas  79106
Children's Hospital of Austin Austin, Texas  78701
Covenant Children's Hospital Lubbock, Texas  79410
Children's Hospital of the King's Daughters Norfolk, Virginia  23507
Bellin Memorial Hospital Green Bay, Wisconsin  54301
Arizona Cancer Center at University of Arizona Health Sciences Center Tucson, Arizona  85724
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences Little Rock, Arkansas  72205
Markey Cancer Center at University of Kentucky Chandler Medical Center Lexington, Kentucky  40536-0084
Tulane Cancer Center at Tulane University Hospital and Clinic New Orleans, Louisiana  70112
Herbert Irving Comprehensive Cancer Center at Columbia University New York, New York  10032
Blumenthal Cancer Center at Carolinas Medical Center Charlotte, North Carolina  28232-2861
St. Vincent Hospitals and Health Care Centers Indianapolis, Indiana  46260
SUNY Downstate Medical Center Brooklyn, New York  11203
Ireland Cancer Center at University Hospitals of Cleveland and Case Western Reserve University Cleveland, Ohio  44106
Loma Linda University Cancer Institute at Loma Linda University Medical Center Loma Linda, California  92354
Jonathan Jaques Children's Cancer Center at Miller Children's Hospital Long Beach, California  90801
Baptist-South Miami Regional Cancer Program Miami, Florida  33176
Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center Savannah, Georgia  31403-3089
Blank Children's Hospital Des Moines, Iowa  50309
Alvin and Lois Lapidus Cancer Institute at Sinai Hospital Baltimore, Maryland  21215
Breslin Cancer Center at Ingham Regional Medical Center Lansing, Michigan  48910
SUNY Upstate Medical University Hospital Syracuse, New York  13210
Cincinnati Children's Hospital Medical Center Cincinnati, Ohio  45229-3039
Legacy Emanuel Hospital and Health Center & Children's Hospital Portland, Oregon  97227
Hollings Cancer Center at Medical University of South Carolina Charleston, South Carolina  29425
Massey Cancer Center at Virginia Commonwealth University Richmond, Virginia  23298-0037
West Virginia University - Robert C. Byrd Health Sciences Center - Charleston Division Charleston, West Virginia  25302
CCOP - Marshfield Clinic Research Foundation Marshfield, Wisconsin  54449
St. Mary's - Duluth Clinic Cancer Center Duluth, Minnesota  55805
James P. Wilmot Cancer Center at University of Rochester Medical Center Rochester, New York  14642
Vermont Cancer Center at University of Vermont Burlington, Vermont  05405-0075
Group Health Central Hospital Seattle, Washington  98104
Lombardi Cancer Center at Georgetown University Medical Center Washington, District of Columbia  20007
Greenebaum Cancer Center at University of Maryland Medical Center Baltimore, Maryland  21201
Josephine Ford Cancer Center at Henry Ford Health System Detroit, Michigan  48202
UNMC Eppley Cancer Center at the University of Nebraska Medical Center Omaha, Nebraska  68198-7680
New York Weill Cornell Cancer Center at Cornell University New York, New York  10021
Lucile Packard Children's Hospital at Stanford University Medical Center Palo Alto, California  95798
Alfred I. duPont Hospital for Children Wilmington, Delaware  19803
AFLAC Cancer Center and Blood Disorders Service of Children's Healthcare of Atlanta - Scottish Rite Campus Atlanta, Georgia  30342
University of South Alabama Cancer Research Institute Mobile, Alabama  36604
Cedars-Sinai Comprehensive Cancer Center at Cedars-Sinai Medical Center Los Angeles, California  90048
Children's Hospital and Research Center at Oakland Oakland, California  94609-1809
Kaiser Permanente Medical Center - Sacramento Sacramento, California  95825
Children's Hospital and Health Center, San Diego San Diego, California  92123-4282
University of Connecticut Comprehensive Cancer Center at University of Connecticut Health Center Farmington, Connecticut  06360-7106
Shands Cancer Center at the University of Florida Health Science Center Gainesville, Florida  32610-0296
Jackson Memorial Hospital Miami, Florida  33136
St. Joseph's Children's Hospital Tampa, Florida  33677-4227
MBCCOP-Medical College of Georgia Cancer Center Augusta, Georgia  30912-4000
Mountain States Tumor Institute - Boise Boise, Idaho  83712
University of Illinois Medical Center Chicago, Illinois  60612
Riley Children Cancer Center at Riley Hospital for Children Indianapolis, Indiana  46202-5225
Baystate Regional Cancer Program at Baystate Medical Center Springfield, Massachusetts  01107
William Beaumont Hospital - Royal Oak Royal Oak, Michigan  48073-6769
Children's Hospitals and Clinics - Minnesota Saint Paul, Minnesota  55102
Cancer Center at Hackensack University Medical Center Hackensack, New Jersey  07601
Cancer Institute of New Jersey at Robert Wood Johnson University Hospital New Brunswick, New Jersey  08903
Valerie Fund Children's Center at Atlantic Health Summit, New Jersey  07901
Comprehensive Cancer Center at Maimonides Medical Center Brooklyn, New York  11219
Mission Hospitals Asheville, North Carolina  28801
Leo W. Jenkins Cancer Center of University Health Systems of Eastern Carolina Greenville, North Carolina  27858-4354
Dakota Cancer Institute at Innovis Health - Dakota Clinic Fargo, North Dakota  58103-4940
Children's Hospital at Oklahoma University Medical Center Oklahoma City, Oklahoma  73104
Doernbecher Children's Hospital at Oregon Health & Science University Portland, Oregon  97239-3098
Sioux Valley Hospital at University of South Dakota Medical Center Sioux Falls, South Dakota  57117-5039
East Tennessee State University Cancer Center at Johnson City Medical Center Johnson City, Tennessee  37604
Vanderbilt Children's Hospital Nashville, Tennessee  37232-6310
Simmons Cancer Center at University of Texas Southwestern Medical Center - Dallas Dallas, Texas  75390-9063
Methodist Cancer Center at Methodist Specialty and Transplant Hospital San Antonio, Texas  78229-3902
MBCCOP - South Texas Pediatrics San Antonio, Texas  78229-3900
Center for Cancer Prevention and Care at Scott and White Clinic Temple, Texas  76508
Mary Bridge Children's Hospital and Health Center Tacoma, Washington  98415-0299
Cabell Huntington Hospital Huntington, West Virginia  25701
Walter Reed Army Medical Center Silver Spring, Maryland  20910
Columbus Children's Hospital Columbus, Ohio  43205-2696