UnknownPhase 2

Observation of Young Patients With Localized Neuroblastoma Who Have Undergone Surgery Only

140 participantsStarted 2004-12

Plain-language summary

RATIONALE: Observation is closely monitoring a patient's condition and not giving treatment until symptoms appear or change. Observation may help doctors see how effective surgery is in treating neuroblastoma. PURPOSE: This phase II trial is studying how well surgery alone works in treating young patients with localized neuroblastoma.

Who can participate

Age range20 Years

SexALL

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 confirmed neuroblastoma or ganglioneuroblastoma * Meets 1 of the following International Neuroblastoma Staging System (INSS) criteria: * Stage 1 * Stage 2A or 2B meeting 1 of the following criteria: * With or without N-myc amplification * No evaluation of NMA * Symptomatic spinal cord compression * Stage 3\* * Dumbbell syndrome with clinical signs of spinal cord compression\* * NOTE: \*These patients are eligible for the study but do not undergo observation; instead they will undergo standard treatment * Has undergone complete or gross surgical resection OR diagnostic surgical or needle biopsy * No metastases within 1 month of diagnosis * No skin metastases by clinical examination and MIBG scan * Normal liver by CT scan or ultrasonography * Normal chest X-ray (in case of nonthoracic primary site) PATIENT CHARACTERISTICS: * Not specified PRIOR CONCURRENT THERAPY: * See Disease Characteristics * Prior steroids allowed * No prior chemotherapy

What they're measuring

Safety and efficacy

Trial details

NCT IDNCT00416559

SponsorChildren's Cancer and Leukaemia Group

Sponsor typeOTHER

Study typeINTERVENTIONAL

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