Ignite Creation Date:
2024-05-05 @ 9:35 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002495
Status:
COMPLETED
Last Update Posted:
2017-02-20
First Post:
1999-11-01
Brief Title:
SWOG-9133 RT w or wo Doxorubicin and Vinblastine in Stage I or Stage II Hodgkins Disease
Sponsor:
SWOG Cancer Research Network
Organization:
SWOG Cancer Research Network
Study Overview
Official Title:
Randomized Trial of Subtotal Nodal Irradiation Versus Doxorubicin Vinblastine and Subtotal Nodal Irradiation for Stage I-IIA Hodgkins Disease
Status:
COMPLETED
Status Verified Date:
2017-02
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:
RATIONALE Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die Combining radiation therapy with chemotherapy may kill more tumor cells
PURPOSE Randomized phase III trial to compare the effectiveness of radiation therapy with or without doxorubicin and vinblastine in treating patients with stage I or stage II Hodgkins disease
PURPOSE Randomized phase III trial to compare the effectiveness of radiation therapy with or without doxorubicin and vinblastine in treating patients with stage I or stage II Hodgkins disease
Detailed Description:
OBJECTIVES I Compare progression-free and overall survival of patients with clinical Stage IAIIA Hodgkins disease who have not undergone laparotomy and who are randomized to treatment with subtotal nodal irradiation with vs without 3 courses of doxorubicinvinblastine II Compare the long-term toxicities associated with these treatments including cardiopulmonary toxicity secondary malignancies and infertility III Identify subgroups of patients based on age gender tumor histology number of disease sites and presence of high neck presentation that are particularly responsive to these treatments
OUTLINE Randomized study Arm I Radiotherapy Subtotal nodal irradiation using megavoltage equipment 4-10 MeV Arm II 2-Drug Combination Chemotherapy followed by Radiotherapy Doxorubicin DOX NSC-123127 Vinblastine VBL NSC-49842 followed by subtotal nodal irradiation as in Arm I
PROJECTED ACCRUAL 210 patientsarm will be enrolled over about 7 years
OUTLINE Randomized study Arm I Radiotherapy Subtotal nodal irradiation using megavoltage equipment 4-10 MeV Arm II 2-Drug Combination Chemotherapy followed by Radiotherapy Doxorubicin DOX NSC-123127 Vinblastine VBL NSC-49842 followed by subtotal nodal irradiation as in Arm I
PROJECTED ACCRUAL 210 patientsarm will be enrolled over about 7 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 |
|---|---|---|---|
| CLB-9391 | OTHER | CALGB | httpsreporternihgovquickSearchU10CA032102 |
| SWOG-9133 | OTHER | None | None |
| U10CA032102 | NIH | None | None |