CompletedPhase 3

Surgery in Treating Children With Neuroblastoma

United States, Australia, Canada968 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 range

21 Years

Sex

ALL

See this in plain English?

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…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Estimate the 3 year survival rate for low risk asymptomatic stage 2A/2B patients who are treated with surgery alone

Trial details

NCT IDNCT00003119

SponsorChildren's Oncology Group

Sponsor typeNETWORK

Study typeINTERVENTIONAL

Primary completion2006-03

View on ClinicalTrials.gov More Neuroblastoma trials

Who can participate

Age range

21 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.