Ignite Creation Date:
2024-05-05 @ 11:29 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00053872
Status:
UNKNOWN
Last Update Posted:
2014-06-24
First Post:
2003-02-05
Brief Title:
Radiation Therapy Plus Combination Chemotherapy in Treating Children With Medulloblastoma
Sponsor:
University of Leicester
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Prospective Randomised Controlled Trial Of Hyperfractionated Versus Conventionally Fractionated Radiotherapy In Standard Risk Medulloblastoma
Status:
UNKNOWN
Status Verified Date:
2007-02
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Radiation therapy uses high-energy x-rays to damage tumor cells Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die Giving radiation therapy in different ways with combination chemotherapy may kill any remaining tumor cells following surgery It is not yet known which radiation therapy regimen combined with combination chemotherapy is more effective in treating medulloblastoma
PURPOSE Randomized phase III trial to compare different radiation therapy regimens plus combination chemotherapy in treating children who have undergone surgery for medulloblastoma
PURPOSE Randomized phase III trial to compare different radiation therapy regimens plus combination chemotherapy in treating children who have undergone surgery for medulloblastoma
Detailed Description:
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
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 chemotherapySix 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
PROJECTED ACCRUAL A total of 316 patients 158 per treatment arm will be accrued for this study within 4 years
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
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 chemotherapySix 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
PROJECTED ACCRUAL A total of 316 patients 158 per treatment arm will be accrued for this study within 4 years
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| SIOP-PNET-4 | None | None | None |
| EU-20244 | None | None | None |
| UKCCSG-CNS-2003-05 | None | None | None |