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Phase III Randomized Study of Conventional Versus Hyperfractionated Radiotherapy and Vincristine Followed By Cisplatin, Lomustine, and Vincristine in Pediatric Patients With Standard-Risk Medulloblastoma
Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information
Alternate Title
Radiation Therapy Plus Combination Chemotherapy in Treating Children With Medulloblastoma
Basic Trial Information
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Protocol IDs
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Phase III
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Treatment
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Closed
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3-21
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SIOP-PNET-4
EU-20244, UKCCSG-CNS-2003-05, NCT00053872
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Objectives - Compare the event-free survival rate in pediatric patients with standard-risk medulloblastoma treated with conventional vs hyperfractionated radiotherapy and vincristine followed by maintenance with cisplatin, lomustine, and vincristine.
- Compare the overall survival of patients treated with these regimens.
- Compare the pattern of relapse, especially local relapse (tumor bed or posterior fossa outside tumor bed), in patients treated with these regimens.
- Determine the toxicity of surgery and whether there are identifiable factors that correlate with toxicity in these patients.
- Determine the impact of any surgical complications on commencement of adjuvant therapy and event-free survival of these patients.
- Compare late sequelae, in terms of health status, endocrine deficiencies, and hearing loss, in patients treated with these regimens.
Entry Criteria Disease Characteristics:
- Histologically confirmed medulloblastoma, including the following variants:
- Classic
- Nodular/desmoplastic
- Large cell
- Melanotic
- Medullomyoblastoma
- Prior total or subtotal surgical removal of tumor within the past 28-40 days
- No more than 1.5 cm2 residual tumor by early postoperative MRI or CT scan
- No brainstem or supratentorial primitive neuroectodermal tumor
- No atypical teratoid rhabdoid tumor
- No known predisposition to medulloblastoma (e.g., Gorlin's syndrome)
- No CNS metastasis (supratentorial, arachnoid of the posterior fossa, or craniospinal axis) by MRI
- No clinical evidence of metastasis outside the CNS
- No tumor cells in lumbar cerebrospinal fluid by cytospin
Prior/Concurrent Therapy:
Biologic therapy Chemotherapy Endocrine therapy - Concurrent dexamethasone as an antiemetic allowed, provided all other therapies have failed
Radiotherapy - No concurrent cobalt irradiation
Surgery - See Disease Characteristics
Other - No prior treatment for brain tumor or any other malignancy
Patient Characteristics:
Age Performance status Life expectancy Hematopoietic - Hematological function less than CTC grade 2
Hepatic - Liver function less than CTC grade 2
Renal - Renal function less than CTC grade 2
Other - Not pregnant
- Fertile patients must use effective contraception
- Able to receive radiotherapy twice daily
- Vital functions within age-appropriate normal range
- Audiological function less than CTC grade 2
- No medical contraindication to radiotherapy or chemotherapy
Expected Enrollment 316A total of 316 patients (158 per treatment arm) will be accrued for this study within 4 years. Outcomes Primary Outcome(s)Comparison of event-free survival at 3 years
Secondary Outcome(s)Comparison of overall survival
Comparison of the pattern of relapse (i.e., local relapse [tumor bed and posterior fossa outside tumor bed])
Comparison of late sequelae, in terms of health status, quality of life, hearing loss, and endocrine deficiencies
Toxicity of neurosurgery
Outline This is a randomized, multicenter study. Patients are stratified according to country. Patients are randomized to 1 of 2 treatment arms. - Arm I: Within 28-40 days after surgical resection, patients undergo conventional fractionated radiotherapy once daily, 5 days a week, for 6-7 weeks. Patients also receive vincristine IV once weekly for 8 weeks.
- Arm II: Beginning as in arm I, patients undergo hyperfractionated radiotherapy twice daily, 5 days a week, for 6-7 weeks. Patients also receive vincristine as in arm I.
- Maintenance chemotherapy:Six weeks after completion of radiotherapy, all patients receive cisplatin IV over 6 hours and oral lomustine on day 1 and vincristine IV on days 1, 8, and 15. Treatment repeats every 6 weeks for 8 courses.
Patients are followed at least every 6 months for 3 years. Peer Reviewed and Funded or Endorsed by Cancer Research UK
Trial Contact Information
Trial Lead Organizations University Hospitals of Leicester NHS Trust | | | | Brigitta Lannering, MD, PhD, Protocol chair | | | |
| Registry Information | | | Official Title | | A Prospective Randomised Controlled Trial Of Hyperfractionated Versus Conventionally Fractionated Radiotherapy In Standard Risk Medulloblastoma | | | Trial Start Date | | 2003-02-01 | | | Registered in ClinicalTrials.gov | | NCT00053872 | | | Date Submitted to PDQ | | 2002-12-09 | | | Information Last Verified | | 2007-02-05 |
Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.  Back to Top |
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