Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003389
Status:
COMPLETED
Last Update Posted:
2023-06-29
First Post:
1999-11-01
Brief Title:
Combination Chemotherapy With or Without Radiation Therapy in Treating Patients With Hodgkins Lymphoma
Sponsor:
Eastern Cooperative Oncology Group
Organization:
Eastern Cooperative Oncology Group
Study Overview
Official Title:
A Randomized Phase III Trial of ABVD Versus Stanford V - Radiation Therapy in Locally Extensive and Advanced Stage Hodgkins Disease
Status:
COMPLETED
Status Verified Date:
2023-06
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 more than one drug with radiation therapy may kill more cancer cells It is not yet known which combination chemotherapy regimen is most effective in treating Hodgkins lymphoma
PURPOSE This randomized phase III trial is studying two different combination chemotherapy regimens and comparing how well they work with or without radiation therapy in treating patients with Hodgkins lymphoma
PURPOSE This randomized phase III trial is studying two different combination chemotherapy regimens and comparing how well they work with or without radiation therapy in treating patients with Hodgkins lymphoma
Detailed Description:
OBJECTIVES
Compare the failure-free survival of patients with locally extensive or advanced Hodgkins lymphoma treated with doxorubicin bleomycin vinblastine and dacarbazine ABVD vs doxorubicin vinblastine vincristine bleomycin mechlorethamine etoposide and prednisone Stanford V with or without radiotherapy
Compare the overall survival and freedom from progression in these patients at 5 and 10 years after treatment with these regimens
Compare pulmonary function incidence of second cancers reproductive function and deaths from causes other than Hodgkins lymphoma in patients treated with these regimens
OUTLINE This is a randomized study Patients are stratified according to number of adverse risk factors 0-2 vs 3-7 disease characteristics locally extensive vs advanced and time of entry before addendum 6 vs after addendum 6 Patients are randomized to 1 of 2 treatment arms
Arm A ABVD Patients receive doxorubicin 25 mgm² bleomycin 10 um² vinblastine 6 mgm² and dacarbazine 375 mgm² IV on days 1 and 15 Courses repeat every 28 days Patients are restaged after 4 courses Patients who are in complete remission receive 2 additional courses Patients with a partial response or less are evaluated after 6 courses and if there is an ongoing response patients may receive 2 additional courses for a total of 8 If no ongoing response is observed patients are removed from the study All patients with massive mediastinal disease regardless of stage receive radiotherapy 2-3 weeks after completion of chemotherapy
Arm B Stanford V Patients receive Stanford V chemotherapy comprising doxorubicin 25 mgm² and vinblastine 6 mgm² IV on day 1 of weeks 1 3 5 7 9 and 11 vincristine 14 mgm² and bleomycin 5 um² IV on day 1 of weeks 2 4 6 8 10 and 12 mechlorethamine 6 mgm² IV on day 1 of weeks 1 5 and 9 if mechlorethamine is unavailable may substitute with cyclophosphamide 375 mgm² IV etoposide 60 mgm² IV on days 1 and 2 of weeks 3 7 and 11 and oral prednisone 40 mgm² every other day of weeks 1-9 followed by a taper All patients with bulky disease receive radiotherapy 2-3 weeks after completion of chemotherapy
Patients are followed every 2 months for 1 year every 3 months for 1 year every 4 months for 1 year every 6 months for 2 years and then annually thereafter
PROJECTED ACCRUAL A total of 850 patients will be accrued for this study within 43 years
Compare the failure-free survival of patients with locally extensive or advanced Hodgkins lymphoma treated with doxorubicin bleomycin vinblastine and dacarbazine ABVD vs doxorubicin vinblastine vincristine bleomycin mechlorethamine etoposide and prednisone Stanford V with or without radiotherapy
Compare the overall survival and freedom from progression in these patients at 5 and 10 years after treatment with these regimens
Compare pulmonary function incidence of second cancers reproductive function and deaths from causes other than Hodgkins lymphoma in patients treated with these regimens
OUTLINE This is a randomized study Patients are stratified according to number of adverse risk factors 0-2 vs 3-7 disease characteristics locally extensive vs advanced and time of entry before addendum 6 vs after addendum 6 Patients are randomized to 1 of 2 treatment arms
Arm A ABVD Patients receive doxorubicin 25 mgm² bleomycin 10 um² vinblastine 6 mgm² and dacarbazine 375 mgm² IV on days 1 and 15 Courses repeat every 28 days Patients are restaged after 4 courses Patients who are in complete remission receive 2 additional courses Patients with a partial response or less are evaluated after 6 courses and if there is an ongoing response patients may receive 2 additional courses for a total of 8 If no ongoing response is observed patients are removed from the study All patients with massive mediastinal disease regardless of stage receive radiotherapy 2-3 weeks after completion of chemotherapy
Arm B Stanford V Patients receive Stanford V chemotherapy comprising doxorubicin 25 mgm² and vinblastine 6 mgm² IV on day 1 of weeks 1 3 5 7 9 and 11 vincristine 14 mgm² and bleomycin 5 um² IV on day 1 of weeks 2 4 6 8 10 and 12 mechlorethamine 6 mgm² IV on day 1 of weeks 1 5 and 9 if mechlorethamine is unavailable may substitute with cyclophosphamide 375 mgm² IV etoposide 60 mgm² IV on days 1 and 2 of weeks 3 7 and 11 and oral prednisone 40 mgm² every other day of weeks 1-9 followed by a taper All patients with bulky disease receive radiotherapy 2-3 weeks after completion of chemotherapy
Patients are followed every 2 months for 1 year every 3 months for 1 year every 4 months for 1 year every 6 months for 2 years and then annually thereafter
PROJECTED ACCRUAL A total of 850 patients will be accrued for this study within 43 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 |
|---|---|---|---|
| U10CA021115 | NIH | Eastern Cooperative Oncology Group ECOG | httpsreporternihgovquickSearchU10CA021115 |
| E2496 | OTHER | None | None |