Ignite Creation Date:
2024-05-05 @ 11:35 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00085735
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-10-11
First Post:
2004-06-14
Brief Title:
Comparison of Radiation Therapy Regimens in Combination With Chemotherapy in Treating Young Patients With Newly Diagnosed Standard-Risk Medulloblastoma
Sponsor:
Childrens Oncology Group
Organization:
Childrens Oncology Group
Study Overview
Official Title:
A Study Evaluating Limited Target Volume Boost Irradiation and Reduced Dose Craniospinal Radiotherapy 1800 Gy and Chemotherapy in Children With Newly Diagnosed Standard Risk Medulloblastoma A Phase III Double Randomized Trial
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-02
Last Known Status:
None
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:
This randomized phase III trial is studying how well standard-dose radiation therapy works compared to reduced-dose radiation therapy in children 3-7 years of age AND how well standard volume boost radiation therapy works compared to smaller volume boost radiation therapy when given together with chemotherapy in treating young patients who have undergone surgery for newly diagnosed standard-risk medulloblastoma Radiation therapy uses high-energy x-rays to damage tumor cells Drugs used in chemotherapy such as vincristine cisplatin lomustine and cyclophosphamide work in different ways to stop tumor cells from dividing so they stop growing or die Giving radiation therapy with chemotherapy after surgery may kill any remaining tumor cells It is not yet known whether standard-dose radiation therapy is more effective than reduced-dose radiation therapy when given together with chemotherapy after surgery in treating young patients with medulloblastoma
Detailed Description:
PRIMARY OBJECTIVES
I Compare event-free survival EFS of pediatric patients 3 to 7 years of age with newly diagnosed standard-risk medulloblastoma treated with standard-dose versus vs reduced-dose craniospinal radiotherapy SDCSI vs LDCSI
II Compare EFS of patients 3-21 years of age treated with standard-dose craniospinal radiotherapy and posterior fossa boost vs tumor bed boost radiotherapy in combination with this chemotherapy regimen
SECONDARY OBJECTIVES
I Compare overall survival OS of pediatric patients 3-7 years of age with newly diagnosed standard-risk medulloblastoma treated with SDCSI vs LDCSI
II Compare OS of patients 3-21 years of age with newly diagnosed standard-risk medulloblastoma treated with PFRT vs IFRT
III To evaluate patterns of failure in patients treated with an irradiation boost volume smaller than conventional posterior fossa volumes
IV To reduce the cognitive auditory and endocrinologic effects of treatment of average-risk medulloblastoma by reducing the dose of craniospinal irradiation therapy
V To determine if the audiologic and endocrinologic toxicity will be reduced with the use of limited tumor boost volume irradiation compared to patients treated with conventional target volumes of radiation
VI Develop an optimal gene expression medulloblastoma outcome predictor validated prospectively in a multi-institution randomized clinical trial
VII To improve compliance with long-term quality of life QoL and functional status data submission by educating institutional nurses to administer and submit for analysis a battery of four instruments Behavior Assessment System for Children- 2nd Edition BASC-2 Adaptive Behavior Assessment System - 2nd Edition ABAS-II Behavior Rating Inventory of Executive Function BRIEF and PedsQLTM 40
OUTLINE Patients 3-7 years of age are randomized to 1 of 4 arms Arm I-IV Patients 8-21 years of age are randomized to 1 of 2 arms Arm V or VI
Within 31 days after definitive surgery all patients begin therapy Patients undergo radiation therapy with doses according to their Arm randomization on days 1-5 8-12 15-19 22-26 29-33 36-40 and 43-47 weeks 0-6 All patients receive vincristine intravenously IV over 1 minute or infusion via minibag as per institutional policy on days 8 15 22 29 36 and 43 weeks 1-6
ARM I Patients 3-7 years of age undergo lowered dose craniospinal irradiation LDCSI with involved-field radiation therapy IFRT boost
ARM II Patients 3-7 years of age undergo LDCSI with whole posterior fossa radiation therapy PFRT boost
ARM III Patients 3-7 years of age undergo standard dose craniospinal irradiation SDCSI with IFRT boost
ARM IV Patients 3-7 years of age undergo SDCSI with PFRT boost
ARM V Patients 8-21 years of age undergo SDCSI with IFRT boost
ARM VI Patients 8-21 years of age undergo SDCSI with PFRT boost
MAINTENANCE CHEMOTHERAPY Beginning 4 weeks after completion of chemoradiotherapy patients receive 2 different regimens of maintenance chemotherapy for a total of 9 courses Each course in regimen A is 6 weeks 42 days in duration Each course in regimen B is 4 weeks 28 days in duration
REGIMEN A courses 1 2 4 5 7 and 8 Patients receive lomustine orally and cisplatin IV over 6 hours on day 1 and vincristine IV on days 1 8 and 15 of weeks 11 17 27 33 43 and 49
REGIMEN B courses 3 6 and 9 Patients receive cyclophosphamide IV over 1 hour on days 1 and 2 and vincristine IV on days 1 and 8 of weeks 23 39 and 55
Treatment continues in the absence of disease progression or unacceptable toxicity Quality of life is assessed at 3-6 months after completion of radiotherapy and at 3-4 years after study entry Neurocognitive function may also be assessed
Patients are followed every 3 months for 1 year every 6 months for 2 years and then annually thereafter
I Compare event-free survival EFS of pediatric patients 3 to 7 years of age with newly diagnosed standard-risk medulloblastoma treated with standard-dose versus vs reduced-dose craniospinal radiotherapy SDCSI vs LDCSI
II Compare EFS of patients 3-21 years of age treated with standard-dose craniospinal radiotherapy and posterior fossa boost vs tumor bed boost radiotherapy in combination with this chemotherapy regimen
SECONDARY OBJECTIVES
I Compare overall survival OS of pediatric patients 3-7 years of age with newly diagnosed standard-risk medulloblastoma treated with SDCSI vs LDCSI
II Compare OS of patients 3-21 years of age with newly diagnosed standard-risk medulloblastoma treated with PFRT vs IFRT
III To evaluate patterns of failure in patients treated with an irradiation boost volume smaller than conventional posterior fossa volumes
IV To reduce the cognitive auditory and endocrinologic effects of treatment of average-risk medulloblastoma by reducing the dose of craniospinal irradiation therapy
V To determine if the audiologic and endocrinologic toxicity will be reduced with the use of limited tumor boost volume irradiation compared to patients treated with conventional target volumes of radiation
VI Develop an optimal gene expression medulloblastoma outcome predictor validated prospectively in a multi-institution randomized clinical trial
VII To improve compliance with long-term quality of life QoL and functional status data submission by educating institutional nurses to administer and submit for analysis a battery of four instruments Behavior Assessment System for Children- 2nd Edition BASC-2 Adaptive Behavior Assessment System - 2nd Edition ABAS-II Behavior Rating Inventory of Executive Function BRIEF and PedsQLTM 40
OUTLINE Patients 3-7 years of age are randomized to 1 of 4 arms Arm I-IV Patients 8-21 years of age are randomized to 1 of 2 arms Arm V or VI
Within 31 days after definitive surgery all patients begin therapy Patients undergo radiation therapy with doses according to their Arm randomization on days 1-5 8-12 15-19 22-26 29-33 36-40 and 43-47 weeks 0-6 All patients receive vincristine intravenously IV over 1 minute or infusion via minibag as per institutional policy on days 8 15 22 29 36 and 43 weeks 1-6
ARM I Patients 3-7 years of age undergo lowered dose craniospinal irradiation LDCSI with involved-field radiation therapy IFRT boost
ARM II Patients 3-7 years of age undergo LDCSI with whole posterior fossa radiation therapy PFRT boost
ARM III Patients 3-7 years of age undergo standard dose craniospinal irradiation SDCSI with IFRT boost
ARM IV Patients 3-7 years of age undergo SDCSI with PFRT boost
ARM V Patients 8-21 years of age undergo SDCSI with IFRT boost
ARM VI Patients 8-21 years of age undergo SDCSI with PFRT boost
MAINTENANCE CHEMOTHERAPY Beginning 4 weeks after completion of chemoradiotherapy patients receive 2 different regimens of maintenance chemotherapy for a total of 9 courses Each course in regimen A is 6 weeks 42 days in duration Each course in regimen B is 4 weeks 28 days in duration
REGIMEN A courses 1 2 4 5 7 and 8 Patients receive lomustine orally and cisplatin IV over 6 hours on day 1 and vincristine IV on days 1 8 and 15 of weeks 11 17 27 33 43 and 49
REGIMEN B courses 3 6 and 9 Patients receive cyclophosphamide IV over 1 hour on days 1 and 2 and vincristine IV on days 1 and 8 of weeks 23 39 and 55
Treatment continues in the absence of disease progression or unacceptable toxicity Quality of life is assessed at 3-6 months after completion of radiotherapy and at 3-4 years after study entry Neurocognitive function may also be assessed
Patients are followed every 3 months for 1 year every 6 months for 2 years and then annually thereafter
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| U10CA098543 | NIH | CTEP | httpsreporternihgovquickSearchU10CA098543 |
| NCI-2009-00335 | REGISTRY | None | None |
| COG-ACNS0331 | None | None | None |
| ACNS0331 | None | None | None |
| CDR0000365506 | None | None | None |
| ACNS0331 | OTHER | None | None |
| ACNS0331 | OTHER | None | None |