Combination Chemotherapy and Surgery With or Without Radiation Therapy in Treating Patients With Stage 2 or Stage 3 Neuroblastoma
NCT ID: NCT00416676
Last Updated: 2013-08-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
30 participants
INTERVENTIONAL
Brief Summary
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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
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* 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.
Conditions
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Keywords
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Study Design
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TREATMENT
NONE
Interventions
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carboplatin
cisplatin
cyclophosphamide
etoposide
vincristine sulfate
adjuvant therapy
conventional surgery
neoadjuvant therapy
radiation therapy
Eligibility Criteria
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Inclusion Criteria
* 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
1 Year
ALL
No
Sponsors
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Children's Cancer and Leukaemia Group
OTHER
Principal Investigators
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Ann Barrett
Role: STUDY_CHAIR
University of Glasgow
Other Identifiers
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CDR0000454571
Identifier Type: REGISTRY
Identifier Source: secondary_id
EU-20594
Identifier Type: -
Identifier Source: secondary_id
CCLG-NB-1993-01
Identifier Type: -
Identifier Source: org_study_id