Trial Information

UKCCSG Stage IIB/3 (INSS) Neuroblastoma Pilot Study [ENSG VI (Pilot 2B/3)]

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.