Ignite Creation Date:
2024-05-05 @ 10:17 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002827
Status:
COMPLETED
Last Update Posted:
2013-08-26
First Post:
1999-11-01
Brief Title:
Chemotherapy Followed by Radiation Therapy in Treating Young Patients With Newly Diagnosed Hodgkins Disease
Sponsor:
Childrens Oncology Group
Organization:
Childrens Oncology Group
Study Overview
Official Title:
RESPONSE DEPENDENT TREATMENT OF STAGES IA IIA AND IIIA HODGKINS DISEASE WITH DBVE AND LOW DOSE INVOLVED FIELD IRRADIATION WITH OR WITHOUT ZINECARD A PEDIATRIC ONCOLOGY GROUP PHASE III STUDY
Status:
COMPLETED
Status Verified Date:
2013-08
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:
RATIONALE Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die Radiation therapy uses high-energy x-rays to damage cancer cells Combining chemotherapy with radiation therapy may kill more cancer cells It is not yet known if chemotherapy is more effective with or without dexrazoxane for Hodgkins disease
PURPOSE Randomized phase III trial to compare the effectiveness of combination chemotherapy with or without dexrazoxane followed by radiation therapy in treating young patients with newly diagnosed stage I stage II or stage III Hodgkins disease
PURPOSE Randomized phase III trial to compare the effectiveness of combination chemotherapy with or without dexrazoxane followed by radiation therapy in treating young patients with newly diagnosed stage I stage II or stage III Hodgkins disease
Detailed Description:
OBJECTIVES I Modify chemotherapy courses based on initial response to therapy in children with newly diagnosed stage IAIIAIIIA1 Hodgkins disease II Examine the activity of variable courses of doxorubicin bleomycin vincristine and etoposide DBVE followed by low-dose involved-field irradiation in these patients III Monitor the safety and feasibility of the response-dependent approach and the morbidity and immediate and long-term toxic effects associated with this regimen IV Assess whether limited therapy is adequate for patients with an early response V Evaluate whether the addition of dexrazoxane can reduce pulmonary toxicity while not significantly reducing the response rate or event-free survival VI Evaluate whether the frequency and magnitude of myocardial injury during therapy as measured by elevated serum cardiac troponin-T is reduced by the addition of dexrazoxane
OUTLINE This is a randomized study Patients are stratified by participating institution Patients are randomly assigned to receive doxorubicin bleomycin vincristine etoposide and filgrastim with vs without dexrazoxane Filgrastim SC begins on days 6-13 no filgrastim is given on day 14 or 15 Filgrastim will restart 2 days after completing therapy and continue until count recovery from expected nadir ANC greater than 1000 cubic meter after nadir Courses repeat every 28 days Those with stable or responding disease after 2-4 courses receive involved-field radiotherapy 5 days per week for 35 weeks Tanner stage IVV patients are eligible for randomization based on a front-end institutional agreement and may receive standard-field radiotherapy 5 days per week for up to 11 weeks at the investigators discretion Patients are followed yearly until relapse death or for a minimum of 10 years
PROJECTED ACCRUAL A total of 285 patients will be accrued for this study over 5 years
OUTLINE This is a randomized study Patients are stratified by participating institution Patients are randomly assigned to receive doxorubicin bleomycin vincristine etoposide and filgrastim with vs without dexrazoxane Filgrastim SC begins on days 6-13 no filgrastim is given on day 14 or 15 Filgrastim will restart 2 days after completing therapy and continue until count recovery from expected nadir ANC greater than 1000 cubic meter after nadir Courses repeat every 28 days Those with stable or responding disease after 2-4 courses receive involved-field radiotherapy 5 days per week for 35 weeks Tanner stage IVV patients are eligible for randomization based on a front-end institutional agreement and may receive standard-field radiotherapy 5 days per week for up to 11 weeks at the investigators discretion Patients are followed yearly until relapse death or for a minimum of 10 years
PROJECTED ACCRUAL A total of 285 patients will be accrued for this study over 5 years
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 |
|---|---|---|---|
| COG-9426 | OTHER | Childrens Oncology Group | None |
| POG-9426 | OTHER | None | None |
| CCG-P9426 | OTHER | None | None |
| CDR0000065013 | OTHER | None | None |