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Perinatal Neuroblastoma: Expectant Observation A Children's Oncology Group Pilot Study

1 Year
Not Enrolling
Adrenocortical Carcinoma, Localized Resectable Neuroblastoma, Precancerous Condition

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Trial Information

Perinatal Neuroblastoma: Expectant Observation A Children's Oncology Group Pilot Study


I. Determine whether nonoperative management of infants with adrenal masses found on
prenatal and/or neonatal imaging results in a 3-year survival rate of 95%.


I. Estimate the percentage of these patients who are spared surgical resection. II. Evaluate
the natural history and histology of perinatal adrenal masses. III. Evaluate the tumor
biology and histology of prenatal and neonatal neuroblastomas.

IV. Determine the tumor characteristics that are associated with a need for resection.


Patients undergo an abdominal CT or MRI scan on weeks 0, 6, and 42 and an abdominal sonogram
on weeks 0, 3, 6, 12, 18, 30, 42, 66, and 90. Urinary catecholamine levels are also measured
on the same weeks as the abdominal sonogram. Patients with an increase in tumor volume or
catecholamine levels undergo sonographic evaluation and urine catecholamine sampling every 3
weeks until stabilization. Patients with a continued increase in catecholamine levels or a
50% increase in tumor volume undergo surgical resection off study.

Patients are followed within 1 week and then every 6 months for 3 years.

Inclusion Criteria:

- Sonographically identified adrenal mass meeting one of the following criteria:

- No greater than 16 mL in volume, if solid

- No greater than 65 mL if at least 25% cystic and does not cross the midline

- Disease limited to the adrenal gland

- No evidence of positive contralateral or ipsilateral lymph nodes or other spread
outside the adrenal gland by CT scan or MRI

- Negative for neuroblastoma cells by bone marrow aspirate

- No evidence of disease outside the adrenal gland by bone scan (+/-MIBG scan)

- Negative for tumor cells by bone marrow biopsy, if performed

- No more than 6 months of age on the date the mass is first identified

- No prior chemotherapy

- No prior abdominal surgery

Type of Study:


Study Design:

Time Perspective: Prospective

Outcome Measure:

Survival rate

Outcome Description:

Estimated using the Kaplan-Meier method.

Outcome Time Frame:

Up to 3 years

Safety Issue:


Principal Investigator

Jed Nuchtern

Investigator Role:

Principal Investigator

Investigator Affiliation:

Children's Oncology Group


United States: Institutional Review Board

Study ID:




Start Date:

July 2001

Completion Date:

Related Keywords:

  • Adrenocortical Carcinoma
  • Localized Resectable Neuroblastoma
  • Precancerous Condition
  • Carcinoma
  • Neuroblastoma
  • Precancerous Conditions
  • Adrenocortical Carcinoma



Baylor College of Medicine Houston, Texas  77030
Children's Hospital of Philadelphia Philadelphia, Pennsylvania  19104
Medical City Dallas Hospital Dallas, Texas  75230
Vanderbilt-Ingram Cancer Center Nashville, Tennessee  37232-6838
Baptist Hospital of Miami Miami, Florida  33176-2197
Newark Beth Israel Medical Center Newark, New Jersey  07112
Dana-Farber Cancer Institute Boston, Massachusetts  02115
Children's Hospital Los Angeles Los Angeles, California  90027-0700
Children's National Medical Center Washington, District of Columbia  20010-2970
Maine Children's Cancer Program Scarborough, Maine  04074-9308
St. Jude Children's Research Hospital Memphis, Tennessee  38105-2794
Southern California Permanente Medical Group Downey, California  90242
Brooklyn Hospital Center Brooklyn, New York  11201
Children's Hospital Medical Center of Akron Akron, Ohio  44308
Cincinnati Children's Hospital Medical Center Cincinnati, Ohio  45229-3039
Primary Children's Medical Center Salt Lake City, Utah  84113-1100
Naval Medical Center - Portsmouth Portsmouth, Virginia  23708-2197
Saint Peter's University Hospital New Brunswick, New Jersey  08901-1780
University of Rochester Rochester, New York  14642
University of Arizona Health Sciences Center Tucson, Arizona  85724
University of Massachusetts Medical School Worcester, Massachusetts  01605
Seattle Children's Hospital Seattle, Washington  98105
Childrens Memorial Hospital Chicago, Illinois  60614
Columbia University Medical Center New York, New York  10032
Mission Hospitals Inc Asheville, North Carolina  28801
Saint Vincent Hospital Green Bay, Wisconsin  54301
Cook Children's Medical Center Fort Worth, Texas  76104
Advocate Lutheran General Hospital Park Ridge, Illinois  60068
Southern Illinois University Springfield, Illinois  62702
Alfred I duPont Hospital for Children Wilmington, Delaware  19803
Rainbow Babies and Childrens Hospital Cleveland, Ohio  44106
East Tennessee Childrens Hospital Knoxville, Tennessee  37916
Saint Joseph's Regional Medical Center Paterson, New Jersey  07503
Children's Hospital Colorado Aurora, Colorado  80045
Sanford USD Medical Center - Sioux Falls Sioux Falls, South Dakota  57117-5134
T C Thompson Children's Hospital Chattanooga, Tennessee  37403
Providence Sacred Heart Medical Center and Children's Hospital Spokane, Washington  99204
The Steven and Alexandra Cohen Children's Medical Center of New York New Hyde Park, New York  11040