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Combination Chemotherapy and Surgery With or Without Radiation Therapy in Treating Patients With Stage 2 or Stage 3 Neuroblastoma

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2006 by National Cancer Institute (NCI).
Recruitment status was:  Active, not recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00416676
First received: December 27, 2006
Last updated: August 1, 2013
Last verified: December 2006
  Purpose

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.


Condition Intervention Phase
Neuroblastoma Drug: carboplatin Drug: cisplatin Drug: cyclophosphamide Drug: etoposide Drug: vincristine sulfate Procedure: adjuvant therapy Procedure: conventional surgery Procedure: neoadjuvant therapy Radiation: radiation therapy Phase 3

Study Type: Interventional
Study Design: Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: UKCCSG Stage IIB/3 (INSS) Neuroblastoma Pilot Study [ENSG VI (Pilot 2B/3)]

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment: 30
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.

  Eligibility

Ages Eligible for Study:   1 Year and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00416676

Sponsors and Collaborators
Children's Cancer and Leukaemia Group
Investigators
Study Chair: Ann Barrett University of Glasgow
  More Information

ClinicalTrials.gov Identifier: NCT00416676     History of Changes
Other Study ID Numbers: CCLG-NB-1993-01
CDR0000454571 ( Registry Identifier: PDQ (Physician Data Query) )
EU-20594
Study First Received: December 27, 2006
Last Updated: August 1, 2013

Keywords provided by National Cancer Institute (NCI):
localized resectable neuroblastoma
localized unresectable neuroblastoma
regional 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
Cyclophosphamide
Carboplatin
Etoposide
Vincristine
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antineoplastic Agents, Phytogenic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators

ClinicalTrials.gov processed this record on August 22, 2017