Surgery in Treating Patients With Neuroblastoma
Recruitment status was Recruiting
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
RATIONALE: Surgery may be an effective treatment for neuroblastoma.
PURPOSE: This phase II trial is studying how well surgery works in treating patients with neuroblastoma.
| Condition | Intervention | Phase |
|---|---|---|
|
Neuroblastoma |
Procedure: surgical procedure |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Treatment |
| Official Title: | Phase II Trial of Surgery as the Only Treatment for INSS Stage 2A & 2B Neuroblastoma |
- Safety and efficacy [ Designated as safety issue: Yes ]
- Predictive factors of relapse and survival [ Designated as safety issue: No ]
| Estimated Enrollment: | 210 |
| Study Start Date: | December 1994 |
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.
Eligibility| Ages Eligible for Study: | up to 20 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Show 96 Study Locations| Study Chair: | Jean Marie Michon, MD | Institut Curie |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00003122 History of Changes |
| Other Study ID Numbers: | CDR0000065880, SIOP-95-1, EU-96053 |
| Study First Received: | November 1, 1999 |
| Last Updated: | December 6, 2011 |
| Health Authority: | Unspecified |
Keywords provided by National Cancer Institute (NCI):
|
localized resectable neuroblastoma localized unresectable neuroblastoma |
Additional relevant MeSH terms:
|
Neuroblastoma Neuroectodermal Tumors, Primitive, Peripheral Neuroectodermal Tumors, Primitive Neoplasms, Neuroepithelial Neuroectodermal Tumors |
Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue |
ClinicalTrials.gov processed this record on June 13, 2013