Ignite Creation Date:
2024-05-05 @ 11:08 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004031
Status:
COMPLETED
Last Update Posted:
2021-02-02
First Post:
1999-12-10
Brief Title:
SWOG-9704 Chemoradiotherapy and Peripheral Stem Cell Transplantation Compared With Combination Chemotherapy in Treating Patients With Non-Hodgkins Lymphoma
Sponsor:
SWOG Cancer Research Network
Organization:
SWOG Cancer Research Network
Study Overview
Official Title:
SWOG-9704 A Randomized Phase III Trial Comparing Early High Dose Chemoradiotherapy and an Autologous Stem Cell Transplant to Conventional Dose CHOP Chemotherapy Plus Rituximab for CD20 B Cell Lymphomas With Possible Late Autologous Stem Cell Transplant for Patients With Diffuse Aggressive Non-Hodgkins Lymphoma in the High-Intermediate and High Risk International Classification Prognostic Groups
Status:
COMPLETED
Status Verified Date:
2021-01
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 Radiation therapy uses high-energy x-rays to damage cancer cells Peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy and radiation and kill more cancer cells It is not yet known whether chemoradiotherapy plus peripheral stem cell transplantation is more effective than combination chemotherapy alone in treating non-Hodgkins lymphoma
PURPOSE This randomized phase III trial is studying chemoradiotherapy and peripheral stem cell transplantation to see how well they work compared to combination chemotherapy in treating patients with stage II stage III or stage IV non-Hodgkins lymphoma
PURPOSE This randomized phase III trial is studying chemoradiotherapy and peripheral stem cell transplantation to see how well they work compared to combination chemotherapy in treating patients with stage II stage III or stage IV non-Hodgkins lymphoma
Detailed Description:
OBJECTIVES
Compare the overall survival and progression-free survival of patients with intermediate- or high-grade non-Hodgkins lymphoma treated with high-dose chemoradiotherapy and autologous peripheral blood stem cell transplantation APBSCT vs conventional dose cyclophosphamide doxorubicin vincristine and prednisone CHOP or CHOP plus rituximab for CD20 disease with possible late APBSCT
Compare the toxic effects of these regimens in this patient population
OUTLINE This is a randomized study Patients are stratified according to disease risk intermediate-high vs high
Patients receive CHOP chemotherapy comprising cyclophosphamide IV over 15 minutes doxorubicin IV and vincristine IV on day 1 and oral prednisone on days 1-5 Patients with CD20-positive disease also receive rituximab IV on day 1 or day 0 during course 1 only Treatment repeats every 3 weeks for 5 courses in the absence of disease progression or unacceptable toxicity
Within 35 days of completing the fifth course patients with partial or complete response are randomized to one of two treatment arms
Arm I Patients receive CHOP or CHOP plus rituximab CHOP-R as above Treatment repeats every 3 weeks for 3 additional courses After completion of chemotherapy patients are encouraged to undergo harvest of peripheral blood stem cells PBSC for possible use at time of relapse After completion of 8 courses patients receive no additional therapy until disease progression or biopsy-proven disease
Arm II Patients receive one additional course of CHOPCHOP-R followed by filgrastim G-CSF sargramostim GM-CSF or other colony-stimulating factors used singly or in combination according to center preference PBSC are harvested and selected for CD34 cells Patients under age 61 receive one of two preparative regimens a total body irradiation TBI-based regimen comprising irradiation administered twice daily on days -8 to -5 etoposide IV over 4 hours on day -4 and cyclophosphamide IV over 1 hour on day -2 OR carmustine IV over 2 hours on days -6 to -4 and etoposide and cyclophosphamide as in the TBI-based regimen Patients age 61 to 65 receive the augmented regimen comprising carmustine etoposide and cyclophosphamide as above Patients receive involved field radiotherapy prior to the preparative regimen only if there is biopsy-proven residual bulk disease and at the discretion of the center PBSC are reinfused 36-48 hours after completion of cyclophosphamide If both bone marrow and PBSC are harvested bone marrow is reinfused on day 0 and then PBSC are reinfused either the same day or the following day
Patients are followed every 6 months for 2 years and then annually thereafter
PROJECTED ACCRUAL Approximately 360 patients at least 135 per treatment arm will be accrued for this study within 5 years
Compare the overall survival and progression-free survival of patients with intermediate- or high-grade non-Hodgkins lymphoma treated with high-dose chemoradiotherapy and autologous peripheral blood stem cell transplantation APBSCT vs conventional dose cyclophosphamide doxorubicin vincristine and prednisone CHOP or CHOP plus rituximab for CD20 disease with possible late APBSCT
Compare the toxic effects of these regimens in this patient population
OUTLINE This is a randomized study Patients are stratified according to disease risk intermediate-high vs high
Patients receive CHOP chemotherapy comprising cyclophosphamide IV over 15 minutes doxorubicin IV and vincristine IV on day 1 and oral prednisone on days 1-5 Patients with CD20-positive disease also receive rituximab IV on day 1 or day 0 during course 1 only Treatment repeats every 3 weeks for 5 courses in the absence of disease progression or unacceptable toxicity
Within 35 days of completing the fifth course patients with partial or complete response are randomized to one of two treatment arms
Arm I Patients receive CHOP or CHOP plus rituximab CHOP-R as above Treatment repeats every 3 weeks for 3 additional courses After completion of chemotherapy patients are encouraged to undergo harvest of peripheral blood stem cells PBSC for possible use at time of relapse After completion of 8 courses patients receive no additional therapy until disease progression or biopsy-proven disease
Arm II Patients receive one additional course of CHOPCHOP-R followed by filgrastim G-CSF sargramostim GM-CSF or other colony-stimulating factors used singly or in combination according to center preference PBSC are harvested and selected for CD34 cells Patients under age 61 receive one of two preparative regimens a total body irradiation TBI-based regimen comprising irradiation administered twice daily on days -8 to -5 etoposide IV over 4 hours on day -4 and cyclophosphamide IV over 1 hour on day -2 OR carmustine IV over 2 hours on days -6 to -4 and etoposide and cyclophosphamide as in the TBI-based regimen Patients age 61 to 65 receive the augmented regimen comprising carmustine etoposide and cyclophosphamide as above Patients receive involved field radiotherapy prior to the preparative regimen only if there is biopsy-proven residual bulk disease and at the discretion of the center PBSC are reinfused 36-48 hours after completion of cyclophosphamide If both bone marrow and PBSC are harvested bone marrow is reinfused on day 0 and then PBSC are reinfused either the same day or the following day
Patients are followed every 6 months for 2 years and then annually thereafter
PROJECTED ACCRUAL Approximately 360 patients at least 135 per treatment arm 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 |
|---|---|---|---|
| U10CA032102 | NIH | SWOG | httpsreporternihgovquickSearchU10CA032102 |
| S9704 | OTHER | None | None |