Ignite Creation Date:
2024-05-05 @ 9:36 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002987
Status:
UNKNOWN
Last Update Posted:
2013-12-04
First Post:
1999-11-01
Brief Title:
Combination Chemotherapy Given With Radiation Therapy or Radiation Therapy Alone in Treating Patients With Early-Stage Hodgkins Disease
Sponsor:
Medical Research Council
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Minimal Initial Therapy MIT for Early Supradiaphragmatic Hodgkins Disease A Multicenter Randomized Trial of Short Neoadjuvant Chemotherapy VAPEC-B Plus Involved Field Radiotherapy MIT Versus Mantle Radiotherapy
Status:
UNKNOWN
Status Verified Date:
2005-03
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 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 combination chemotherapy plus radiation therapy with radiation therapy alone in treating patients with early-stage Hodgkins disease
PURPOSE Randomized phase III trial to compare the effectiveness of combination chemotherapy plus radiation therapy with radiation therapy alone in treating patients with early-stage Hodgkins disease
Detailed Description:
OBJECTIVES I Determine the recurrence rate and long term survival of patients with early stage Hodgkins disease given vincristinedoxorubicinprednisolone etoposidecyclophosphamidebleomycin VAPEC-B chemotherapy and involved field radiation vs mantle radiotherapy
OUTLINE This is a randomized multicenter study Patients are randomized to receive either vincristinedoxorubicinprednisoloneetoposidecyclophosphamide bleomycin VAPEC-B chemotherapy and involved field radiotherapy or mantle radiotherapy only Patients receiving VAPEC-B are given prednisolone daily on weeks 1-6 doxorubicin IV along with cyclophosphamide IV on week 1 doxorubicin IV and etoposide orally for 5 days on week 3 and vincristine and bleomycin IV on weeks 2 and 4 Involved field radiotherapy is commenced at week 6 within 14 to 21 days of the last chemotherapy treatment Patients randomized to receive mantle radiotherapy only are given treatments daily for 4 weeks Patients are followed every 3 months for the first two years every 4 months for the third year every 6 months for the fourth and fifth years and annually thereafter
PROJECTED ACCRUAL 400 patients will be accrued over 4-5 years
OUTLINE This is a randomized multicenter study Patients are randomized to receive either vincristinedoxorubicinprednisoloneetoposidecyclophosphamide bleomycin VAPEC-B chemotherapy and involved field radiotherapy or mantle radiotherapy only Patients receiving VAPEC-B are given prednisolone daily on weeks 1-6 doxorubicin IV along with cyclophosphamide IV on week 1 doxorubicin IV and etoposide orally for 5 days on week 3 and vincristine and bleomycin IV on weeks 2 and 4 Involved field radiotherapy is commenced at week 6 within 14 to 21 days of the last chemotherapy treatment Patients randomized to receive mantle radiotherapy only are given treatments daily for 4 weeks Patients are followed every 3 months for the first two years every 4 months for the third year every 6 months for the fourth and fifth years and annually thereafter
PROJECTED ACCRUAL 400 patients will be accrued over 4-5 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 |
|---|---|---|---|
| EU-97004 | None | None | None |
| MRC-UKLG-LY07 | None | None | None |