Ignite Creation Date:
2024-05-05 @ 10:22 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002714
Status:
COMPLETED
Last Update Posted:
2013-05-15
First Post:
1999-11-01
Brief Title:
Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Early-Stage Hodgkins Disease
Sponsor:
Stanford University
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A PHASE II TRIAL OF EIGHT-WEEK STANFORD V CHEMOTHERAPY PLUS MODIFIED INVOLVED FIELD RADIOTHERAPY IN FAVORABLE LIMITED STAGE HODGKINS DISEASE
Status:
COMPLETED
Status Verified Date:
2001-09
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 Radiation therapy uses high-energy x-rays to damage tumor cells Combining more than one chemotherapy drug with radiation therapy may kill more tumor cells
PURPOSE Phase II trial to study the effectiveness of combination chemotherapy plus radiation therapy in treating patients who have early stage Hodgkins disease
PURPOSE Phase II trial to study the effectiveness of combination chemotherapy plus radiation therapy in treating patients who have early stage Hodgkins disease
Detailed Description:
OBJECTIVES I Determine the progression-free and overall survival at 5 and 10 years after a short-term Stanford V regimen comprising mechlorethamine doxorubicin vinblastine prednisone vincristine bleomycin and etoposide followed by modified involved-field radiotherapy in patients with favorable early-stage Hodgkins disease II Determine whether the early and late toxic effects of treatment can be minimized by avoiding staging laparotomy limiting cumulative doses of chemotherapeutic drugs and reducing the dose and volume of radiotherapy in these patients III Determine the freedom from second disease progression at 5 and 10 years after treatment and treatment-related toxicity in these patients IV Determine the quality of life of patients treated with this regimen
OUTLINE Patients receive the Stanford V regimen comprising mechlorethamine IV on days 1 and 29 doxorubicin IV and vinblastine IV on days 1 15 29 and 43 oral prednisone every other day on days 1-36 followed by tapered doses vincristine IV and bleomycin IV on days 8 22 36 and 50 and etoposide IV on days 15 16 43 and 44 Beginning 2 weeks after completion of chemotherapy and when blood counts recover patients undergo modified involved-field radiotherapy 5 days a week for 3-4 weeks Quality of life is assessed Patients are followed every 3 months for 2 years every 6 months for 3 years and then annually thereafter
PROJECTED ACCRUAL A total of 50 patients will be accrued for this study within 5 years
OUTLINE Patients receive the Stanford V regimen comprising mechlorethamine IV on days 1 and 29 doxorubicin IV and vinblastine IV on days 1 15 29 and 43 oral prednisone every other day on days 1-36 followed by tapered doses vincristine IV and bleomycin IV on days 8 22 36 and 50 and etoposide IV on days 15 16 43 and 44 Beginning 2 weeks after completion of chemotherapy and when blood counts recover patients undergo modified involved-field radiotherapy 5 days a week for 3-4 weeks Quality of life is assessed Patients are followed every 3 months for 2 years every 6 months for 3 years and then annually thereafter
PROJECTED ACCRUAL A total of 50 patients will be accrued for this study within 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 |
|---|---|---|---|
| NCI-H96-0805 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000064550 | REGISTRY | None | None |