Ignite Creation Date:
2024-05-05 @ 11:27 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00041210
Status:
UNKNOWN
Last Update Posted:
2013-09-20
First Post:
2002-07-08
Brief Title:
Combination Chemotherapy in Treating Patients With Previously Untreated Advanced Hodgkins Lymphoma
Sponsor:
Mount Vernon Cancer Centre at Mount Vernon Hospital
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Protocol for a Randomized Phase III Study of the Stanford V Regimen Compared With ABVD for the Treatment of Advanced Hodgkins Disease
Status:
UNKNOWN
Status Verified Date:
2009-04
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 Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die Combining more than one drug may kill more cancer cells It is not yet known which combination chemotherapy regimen is more effective in treating patients who have advanced Hodgkins lymphoma
PURPOSE Randomized phase III trial to compare the effectiveness of two different combination chemotherapy regimens in treating patients who have advanced Hodgkins lymphoma
PURPOSE Randomized phase III trial to compare the effectiveness of two different combination chemotherapy regimens in treating patients who have advanced Hodgkins lymphoma
Detailed Description:
OBJECTIVES
Compare relapse-free and overall survival of patients with previously untreated advanced Hodgkins lymphoma treated with bleomycin doxorubicin etoposide mechlorethamine vinblastine vincristine and prednisone Stanford V vs doxorubicin bleomycin vinblastine and dacarbazine ABVD
Compare the toxicity of these regimens in these patients
OUTLINE This is a randomized multicenter study Patients are randomized to 1 of 2 treatment arms
Arm I Stanford V Patients receive mechlorethamine on weeks 1 5 and 9 vinblastine and doxorubicin on weeks 1 3 5 7 9 and 11 etoposide IV over 30-45 minutes for 2 consecutive days on weeks 3 7 and 11 and vincristine and bleomycin on weeks 2 4 6 8 10 and 12 Patients also receive oral prednisone every other day on days 1-63 followed by a taper on days 64-84 Treatment continues for 12 weeks
Arm II ABVD Patients receive doxorubicin bleomycin vinblastine and dacarbazine on days 1 and 15 Treatment repeats every 28 days for 6-8 courses
All patients achieving a complete remission or partial remission after chemotherapy undergo involved field radiotherapy if they had initial bulky mediastinal disease initial nodal masses at least 5 cm in diameter or initial splenic disease
Patients are followed every 3 months for 1 year every 4 months for 1 year every 6 months for 3 years and then annually thereafter
Peer Reviewed and Funded or Endorsed by Cancer Research UK
PROJECTED ACCRUAL Approximately 700-850 patients will be accrued for this study
Compare relapse-free and overall survival of patients with previously untreated advanced Hodgkins lymphoma treated with bleomycin doxorubicin etoposide mechlorethamine vinblastine vincristine and prednisone Stanford V vs doxorubicin bleomycin vinblastine and dacarbazine ABVD
Compare the toxicity of these regimens in these patients
OUTLINE This is a randomized multicenter study Patients are randomized to 1 of 2 treatment arms
Arm I Stanford V Patients receive mechlorethamine on weeks 1 5 and 9 vinblastine and doxorubicin on weeks 1 3 5 7 9 and 11 etoposide IV over 30-45 minutes for 2 consecutive days on weeks 3 7 and 11 and vincristine and bleomycin on weeks 2 4 6 8 10 and 12 Patients also receive oral prednisone every other day on days 1-63 followed by a taper on days 64-84 Treatment continues for 12 weeks
Arm II ABVD Patients receive doxorubicin bleomycin vinblastine and dacarbazine on days 1 and 15 Treatment repeats every 28 days for 6-8 courses
All patients achieving a complete remission or partial remission after chemotherapy undergo involved field radiotherapy if they had initial bulky mediastinal disease initial nodal masses at least 5 cm in diameter or initial splenic disease
Patients are followed every 3 months for 1 year every 4 months for 1 year every 6 months for 3 years and then annually thereafter
Peer Reviewed and Funded or Endorsed by Cancer Research UK
PROJECTED ACCRUAL Approximately 700-850 patients will be accrued for this study
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 |
|---|---|---|---|
| EU-20206 | None | None | None |
| BNLI-STANFORDV | None | None | None |