Suspended

Phase II Trial of Surgery as the Only Treatment for INSS Stage 2A & 2B Neuroblastoma

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What is being tested

surgical procedure

Procedure
Who is being recruted

Neoplasms+7

+ Neoplasms by Histologic Type

+ Neoplasms, Germ Cell and Embryonal

Until 20 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: December 1994
See protocol details

Summary

Principal SponsorSociete Internationale d'Oncologie Pediatrique
Study ContactChristian UrbanMore contacts
Last updated: August 26, 2013
Sourced from a government-validated database.Claim as a partner

Study start date: December 1, 1994

Actual date on which the first participant was enrolled.

OBJECTIVES: Evaluate the safety and efficacy of surgical treatment alone for stage II neuroblastoma without N-myc amplification (NMA). Describe predictive factors of relapse and survival for stages I and II neuroblastoma without NMA treated by surgery alone. OUTLINE: Patients with localized resectable tumors undergo surgery. Postoperative evaluations are performed 30 days following surgery. Study patients with stage I (without N-myc amplification) tumors and trial patients with stage II tumors receive no further therapy. Study patients (except stage I patients) receive surgery and/or chemotherapy according to other protocols as necessary for disease progression or relapse. Patients are followed every 3 months for the first year, then every 4 and 6 months for the second and third year respectively, then yearly for 5 years. PROJECTED ACCRUAL: This study will accrue 140 stage II patients for the trial portion at a rate of 40 per year over 3.5 years. At least 70 more patients will be accrued for the study portion.

NCT00003122
Principal SponsorSociete Internationale d'Oncologie Pediatrique
Study ContactChristian UrbanMore contacts
Last updated: August 26, 2013
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

210 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Until 20 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

NeoplasmsNeoplasms by Histologic TypeNeoplasms, Germ Cell and EmbryonalNeoplasms, Glandular and EpithelialNeoplasms, Nerve TissueNeuroectodermal TumorsNeuroectodermal Tumors, Primitive, PeripheralNeuroectodermal Tumors, PrimitiveNeoplasms, NeuroepithelialNeuroblastoma

Criteria

DISEASE CHARACTERISTICS: Trial: Histologically proven International Neuroblastoma Staging System (INSS) stage IIA and IIB neuroblastoma without amplification of the N-myc oncogene Study: Histologically proven neuroblastoma Stage I Stage II with amplified N-myc Stage II without evaluation of N-myc Stage II with symptomatic spinal cord compression Stage III No metastases diagnosed within 1 month of study PATIENT CHARACTERISTICS: Age: 20 and under Performance status: Not specified Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy No adjuvant chemotherapy planned Endocrine therapy: Prior use of steroids allowed Radiotherapy: Not specified Surgery: Not specified

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 96 locations

Recruiting

Universitaet Kinderklinik

Graz, AustriaOpen Universitaet Kinderklinik in Google Maps
Recruiting

Innsbruck Universitaetsklinik

Innsbruck, Austria
Recruiting

Landeskrankenhaus Klagenfurt

Klagenfurt, Austria
Recruiting

LKH Leoben

Leoben, Austria
Suspended96 Study Centers