Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003421
Status:
COMPLETED
Last Update Posted:
2013-12-04
First Post:
1999-11-01
Brief Title:
Combination Chemotherapy in Treating Patients With Advanced Hodgkins Disease
Sponsor:
Medical Research Council
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A UKLG Randomised Trial of Initial Chemotherapy for Advanced Stage Hodgkins Disease
Status:
COMPLETED
Status Verified Date:
2007-05
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 tumor cells from dividing so they stop growing or die Combining more than one drug may kill more tumor cells It is not yet known which chemotherapy regimen is more effective for advanced Hodgkins disease
PURPOSE Randomized phase III trial to compare different combination chemotherapy regimens in treating patients with advanced Hodgkins disease
PURPOSE Randomized phase III trial to compare different combination chemotherapy regimens in treating patients with advanced Hodgkins disease
Detailed Description:
OBJECTIVES I Determine whether a four-drug anthracycline-based regimen or a seven-drug hybrid or eight-drug alternating regimen is the optimal treatment for patients with advanced Hodgkins disease
OUTLINE This is a randomized study Patients are randomized to one of two treatment arms Arm I ABVD Patients receive doxorubicin IV bleomycin IV vinblastine IV and dacarbazine IV on days 1 and 15 Courses repeat every 4 weeks Arm II ChlVPPPABLOE Patients receive oral chlorambucil procarbazine and prednisolone on days 1-14 vinblastine IV on days 1 and 8 doxorubicin IV on day 29 vincristine IV and bleomycin IV on days 29 and 36 oral etoposide on days 29-31 and oral prednisolone again on days 29-38 Courses repeat every 7 weeks OR Hybrid - ChlVPPEVA Patients receive vincristine IV on day 1 oral etoposide on days 1-5 oral chlorambucil procarbazine and prednisolone on days 1-7 and doxorubicin IV and vinblastine IV on day 8 Courses repeat every 4 weeks Patients in both arms receive up to 6-8 courses of treatment Radiotherapy may be given to sites of previous bulk disease for patients in complete remission or uncertain remission Patients who achieve partial remission may receive radiotherapy to residual disease sites Patients who fail to respond or have disease progression may receive induction therapy followed by high-dose consolidation therapy Patients are followed every 3 months for 2 years every 6 months for 5 years and then annually for 5 years
PROJECTED ACCRUAL Approximately 800 patients will be accrued for this study
OUTLINE This is a randomized study Patients are randomized to one of two treatment arms Arm I ABVD Patients receive doxorubicin IV bleomycin IV vinblastine IV and dacarbazine IV on days 1 and 15 Courses repeat every 4 weeks Arm II ChlVPPPABLOE Patients receive oral chlorambucil procarbazine and prednisolone on days 1-14 vinblastine IV on days 1 and 8 doxorubicin IV on day 29 vincristine IV and bleomycin IV on days 29 and 36 oral etoposide on days 29-31 and oral prednisolone again on days 29-38 Courses repeat every 7 weeks OR Hybrid - ChlVPPEVA Patients receive vincristine IV on day 1 oral etoposide on days 1-5 oral chlorambucil procarbazine and prednisolone on days 1-7 and doxorubicin IV and vinblastine IV on day 8 Courses repeat every 4 weeks Patients in both arms receive up to 6-8 courses of treatment Radiotherapy may be given to sites of previous bulk disease for patients in complete remission or uncertain remission Patients who achieve partial remission may receive radiotherapy to residual disease sites Patients who fail to respond or have disease progression may receive induction therapy followed by high-dose consolidation therapy Patients are followed every 3 months for 2 years every 6 months for 5 years and then annually for 5 years
PROJECTED ACCRUAL Approximately 800 patients will be accrued for this study
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 |
|---|---|---|---|
| EU-98020 | None | None | None |
| MRC-UKLG-LY09 | None | None | None |