Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00031668
Status:
COMPLETED
Last Update Posted:
2020-04-01
First Post:
2002-03-08
Brief Title:
Radiation Therapy in Relapsed or Refractory Non-Hodgkins Lymphoma Who Have Undergone Stem Cell Transplantation
Sponsor:
NCIC Clinical Trials Group
Organization:
Canadian Cancer Trials Group
Study Overview
Official Title:
A Phase III Study of Involved Field Radiation Therapy IFRT in Patients With Histologically Aggressive Non-Hodgkins Lymphoma Following High Dose Chemotherapy and Autologous Hematopoietic Stem Cell Transplantation ASCT
Status:
COMPLETED
Status Verified Date:
2020-03
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 Radiation therapy uses high-energy x-rays to damage tumor cells It is not yet known if giving radiation therapy after stem cell transplantation is more effective than stem cell transplantation alone in treating relapsed or refractory non-Hodgkins lymphoma
PURPOSE Randomized phase III trial to determine the effectiveness of radiation therapy in treating patients who have relapsed or refractory non-Hodgkins lymphoma and have undergone autologous stem cell transplantation
PURPOSE Randomized phase III trial to determine the effectiveness of radiation therapy in treating patients who have relapsed or refractory non-Hodgkins lymphoma and have undergone autologous stem cell transplantation
Detailed Description:
OBJECTIVES
Compare the 3-year progression-free survival of patients with relapsed or refractory aggressive non-Hodgkins lymphoma treated with high-dose chemotherapy and autologous hematopoietic stem cell transplantation with or without involved-field radiotherapy
Compare the overall survival of patients treated with these regimens
Compare 3-year progression-free disease within and outside radiotherapy fields in patients treated with these regimens
Compare quality of life of patients treated with these regimens
Compare the toxic effects of these regimens in these patients
OUTLINE This is a randomized multicenter study Patients are stratified according to response to pre-salvage chemotherapy primary refractory disease vs relapse response to post-salvage chemotherapy completeunconfirmed complete vs partial and participating center Within 6-8 weeks after completion of autologous hematopoietic stem cell transplantation patients are randomized to 1 of 2 treatment arms
Arm I Patients undergo involved-field radiotherapy IFRT 5 days a week for 3-5 weeks in the absence of unacceptable toxicity
Arm II Patients undergo observation only Quality of life in arm I is assessed at baseline on day 1 of IFRT at weeks 2 and 4 during IFRT at 1 month 4 months every 3 months for 2 years every 6 months for 1 year and then annually for 2 years Quality of life in arm II is assessed at baseline 1 month 2 months every 3 months for 2 years every 6 months for 1 year and then annually for 2 years
Patients are followed at 1 month every 3 months for 2 years every 6 months for 1 year and then annually for 2 years
PROJECTED ACCRUAL A total of 230 patients 115 per treatment arm will be accrued for this study within 42 years
Compare the 3-year progression-free survival of patients with relapsed or refractory aggressive non-Hodgkins lymphoma treated with high-dose chemotherapy and autologous hematopoietic stem cell transplantation with or without involved-field radiotherapy
Compare the overall survival of patients treated with these regimens
Compare 3-year progression-free disease within and outside radiotherapy fields in patients treated with these regimens
Compare quality of life of patients treated with these regimens
Compare the toxic effects of these regimens in these patients
OUTLINE This is a randomized multicenter study Patients are stratified according to response to pre-salvage chemotherapy primary refractory disease vs relapse response to post-salvage chemotherapy completeunconfirmed complete vs partial and participating center Within 6-8 weeks after completion of autologous hematopoietic stem cell transplantation patients are randomized to 1 of 2 treatment arms
Arm I Patients undergo involved-field radiotherapy IFRT 5 days a week for 3-5 weeks in the absence of unacceptable toxicity
Arm II Patients undergo observation only Quality of life in arm I is assessed at baseline on day 1 of IFRT at weeks 2 and 4 during IFRT at 1 month 4 months every 3 months for 2 years every 6 months for 1 year and then annually for 2 years Quality of life in arm II is assessed at baseline 1 month 2 months every 3 months for 2 years every 6 months for 1 year and then annually for 2 years
Patients are followed at 1 month every 3 months for 2 years every 6 months for 1 year and then annually for 2 years
PROJECTED ACCRUAL A total of 230 patients 115 per treatment arm will be accrued for this study within 42 years
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
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 |
|---|---|---|---|
| CDR0000069214 | OTHER | PDQ | None |
| CAN-NCIC-LY8 | None | None | None |