Surgery in Treating Children With Neuroblastoma (NCT00003119) | Clinical Trial Compass
CompletedPhase 3
Surgery in Treating Children With Neuroblastoma
United States968 participantsStarted 1998-03
Plain-language summary
RATIONALE: Surgery alone may be effective in treating children with neuroblastoma.
PURPOSE: Phase III trial to study the effectiveness of surgery alone in treating children who have neuroblastoma.
Who can participate
Age range21 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
DISEASE CHARACTERISTICS:
* 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 successor
PATIENT CHARACTERISTICS:
Age:
* Under 21
Performance status:
* Not specified
Life expectancy:
* Not specified
Hematopoietic:
* Not specified
Hepatic:
* Bilirubin less than 1.5 times normal
* SGOT or SGPT less than 2.5 times normal
Renal:
* Creatinine less than 1.5 times normal
Cardiovascular:
* Shortening fraction greater than 27% by echocardiogram OR
* Ejection fraction greater than 47% by radionuclide angiogram
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* No prior immunotherapy
Chemotherapy:
* See Disease Characteristics
Endocrine therapy:
* No…
What they're measuring
1
Estimate the 3 year survival rate for low risk asymptomatic stage 2A/2B patients who are treated with surgery alone