Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00005089
Status:
COMPLETED
Last Update Posted:
2017-01-16
First Post:
2000-04-06
Brief Title:
S0014 Combination Chemotherapy Plus Rituximab and Radiation Therapy in Treating Patients With Stage I or Stage II Non-Hodgkins Lymphoma
Sponsor:
SWOG Cancer Research Network
Organization:
SWOG Cancer Research Network
Study Overview
Official Title:
Evaluation of CHOP Plus Rituximab Plus Involved Field Radiotherapy for Stages I IE and Non-Bulky Stages II and IIE CD20 Positive High-Risk Localized Aggressive Histologies of Non-Hodgkins Lymphoma
Status:
COMPLETED
Status Verified Date:
2017-01
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 Monoclonal antibodies such as rituximab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells Radiation therapy uses high-energy x-rays to damage cancer cells Combining chemotherapy with monoclonal antibody therapy and radiation therapy may kill more cancer cells
PURPOSE Phase II trial to study the effectiveness of combination chemotherapy plus rituximab and radiation therapy in treating patients who have stage I or stage II non-Hodgkins lymphoma
PURPOSE Phase II trial to study the effectiveness of combination chemotherapy plus rituximab and radiation therapy in treating patients who have stage I or stage II non-Hodgkins lymphoma
Detailed Description:
OBJECTIVES I Assess two year progression free survival after treatment with cyclophosphamide doxorubicin vincristine and prednisone CHOP plus rituximab followed by radiotherapy in patients with stage I IE or non-bulky stage II or IIE high risk localized intermediate or high grade non-Hodgkins lymphoma II Determine the toxicity of this treatment in these patients
OUTLINE Patients receive rituximab IV on days 1 and 8 of the first course then on day 1 of courses 2 and 3 Patients receive cyclophosphamide IV over 1-2 hours doxorubicin IV and vincristine IV on day 10 of the first course then on day 3 of courses 2 and 3 Patients receive oral prednisone on days 10-14 of the first course then on days 3-7 of courses 2 and 3 Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity Chemotherapy is followed by radiotherapy administered 5 days a week for 4-5 weeks Patients are followed every 6 months for two years and then annually thereafter
PROJECTED ACCRUAL A total of 60 patients will be accrued for this study
OUTLINE Patients receive rituximab IV on days 1 and 8 of the first course then on day 1 of courses 2 and 3 Patients receive cyclophosphamide IV over 1-2 hours doxorubicin IV and vincristine IV on day 10 of the first course then on day 3 of courses 2 and 3 Patients receive oral prednisone on days 10-14 of the first course then on days 3-7 of courses 2 and 3 Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity Chemotherapy is followed by radiotherapy administered 5 days a week for 4-5 weeks Patients are followed every 6 months for two years and then annually thereafter
PROJECTED ACCRUAL A total of 60 patients will be accrued for this study
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 |
|---|---|---|---|
| U10CA032102 | NIH | SWOG | httpsreporternihgovquickSearchU10CA032102 |
| S0014 | OTHER | None | None |