Combination Chemotherapy and Surgery With or Without Radiation Therapy in Treating Patients With Stage 2 or Stage 3 Neuroblastoma
Primary Purpose
Neuroblastoma
Status
Unknown status
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
carboplatin
cisplatin
cyclophosphamide
etoposide
vincristine sulfate
adjuvant therapy
conventional surgery
neoadjuvant therapy
radiation therapy
Sponsored by
About this trial
This is an interventional treatment trial for Neuroblastoma focused on measuring localized resectable neuroblastoma, localized unresectable neuroblastoma, regional neuroblastoma
Eligibility Criteria
DISEASE CHARACTERISTICS:
Histologically confirmed neuroblastoma
- Stage 2B or 3 disease
Must be able to undergo radical radiotherapy
- Radiotherapy contra-indicated if disease site is near a critical organ (e.g., mass overlying a single functioning kidney or the size of the residual tumor after chemotherapy precludes delivery of the specified radiation dose)
PATIENT CHARACTERISTICS:
- Not specified
PRIOR CONCURRENT THERAPY:
- No prior chemotherapy or radiotherapy
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00416676
First Posted
December 27, 2006
Last Updated
August 1, 2013
Sponsor
Children's Cancer and Leukaemia Group
1. Study Identification
Unique Protocol Identification Number
NCT00416676
Brief Title
Combination Chemotherapy and Surgery With or Without Radiation Therapy in Treating Patients With Stage 2 or Stage 3 Neuroblastoma
Official Title
UKCCSG Stage IIB/3 (INSS) Neuroblastoma Pilot Study [ENSG VI (Pilot 2B/3)]
Study Type
Interventional
2. Study Status
Record Verification Date
December 2006
Overall Recruitment Status
Unknown status
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
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3. Sponsor/Collaborators
Name of the Sponsor
Children's Cancer and Leukaemia Group
4. Oversight
5. Study Description
Brief Summary
RATIONALE: Drugs used in chemotherapy, such as vincristine, cyclophosphamide, cisplatin, etoposide, and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving combination chemotherapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving combination chemotherapy and radiation therapy after surgery may kill any tumor cells that remain after surgery.
PURPOSE: This phase III trial is studying how well giving combination chemotherapy and surgery with or without radiation therapy works in treating patients with stage 2 or stage 3 neuroblastoma.
Detailed Description
OBJECTIVES:
Determine the acute and late toxicity of local radiotherapy when given after vincristine, cisplatin, etoposide, and cyclophosphamide (OPEC) alternating with vincristine, carboplatin, etoposide, and cyclophosphamide (OJEC) chemotherapy and surgery and followed by further chemotherapy in patients with stage 2B or 3 neuroblastoma.
Determine the response in patients treated with alternating OPEC and OJEC chemotherapy before and after surgery.
Determine the local control and event-free and overall survival of patients who achieve a complete response after chemotherapy and surgery alone.
Determine the local control and event-free and overall survival of patients who do not achieve a complete response after chemotherapy and surgery and subsequently receive local radiotherapy.
Determine clinical and biological prognostic factors for patients with stage 2B or 3 neuroblastoma when treated with this approach.
OUTLINE: This is a pilot, multicenter study.
Patients receive OPEC chemotherapy comprising vincristine IV and cyclophosphamide IV on day 1, cisplatin IV continuously over 24 hours on day 1, and etoposide IV over 4 hours on day 3 during courses 1, 3, and 5. Patients receive OJEC chemotherapy comprising vincristine IV, cyclophosphamide IV, etoposide IV over 4 hours, and carboplatin IV over 1 hour on day 1 during courses 2 and 4. Treatment repeats every 21 days for 5 courses. After 5 courses, patients with resectable disease undergo surgical resection. Patients who achieve a complete response (CR), either after surgery or after 5 courses of chemotherapy alone (where surgery is not possible), receive 2 additional courses of chemotherapy (OPEC followed by OJEC). Patients who do not achieve a CR undergo radiotherapy for 3 weeks. During the first week of radiotherapy, these patients also receive vincristine IV on day 1 and etoposide IV over 4 hours on days 1 and 2. Beginning 3 weeks after the completion of radiotherapy, these patients receive 2 additional courses of chemotherapy (OPEC followed by OJEC).
After completion of study treatment, patients are followed periodically for 3 years and then annually thereafter.
PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neuroblastoma
Keywords
localized resectable neuroblastoma, localized unresectable neuroblastoma, regional neuroblastoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Masking
None (Open Label)
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
carboplatin
Intervention Type
Drug
Intervention Name(s)
cisplatin
Intervention Type
Drug
Intervention Name(s)
cyclophosphamide
Intervention Type
Drug
Intervention Name(s)
etoposide
Intervention Type
Drug
Intervention Name(s)
vincristine sulfate
Intervention Type
Procedure
Intervention Name(s)
adjuvant therapy
Intervention Type
Procedure
Intervention Name(s)
conventional surgery
Intervention Type
Procedure
Intervention Name(s)
neoadjuvant therapy
Intervention Type
Radiation
Intervention Name(s)
radiation therapy
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Year
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS:
Histologically confirmed neuroblastoma
Stage 2B or 3 disease
Must be able to undergo radical radiotherapy
Radiotherapy contra-indicated if disease site is near a critical organ (e.g., mass overlying a single functioning kidney or the size of the residual tumor after chemotherapy precludes delivery of the specified radiation dose)
PATIENT CHARACTERISTICS:
Not specified
PRIOR CONCURRENT THERAPY:
No prior chemotherapy or radiotherapy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ann Barrett
Organizational Affiliation
University of Glasgow
Official's Role
Study Chair
12. IPD Sharing Statement
Learn more about this trial
Combination Chemotherapy and Surgery With or Without Radiation Therapy in Treating Patients With Stage 2 or Stage 3 Neuroblastoma
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