This study was designed twelve years ago to compare the efficacy and the long-term survival of two very different therapeutic approaches towards previously untreated patients with indolent lymphoma: observation or delayed therapy (watch and wait) vs. initial intensive combination chemotherapy with ProMACE/MOPP flexitherapy to complete remission, followed by consolidative modified total nodal irradiation. To date there are no significant differences in disease-free survival or overall survival, although there are differences in complete response rates between the two randomized groups with 76% of patients randomized to intensive therapy achieving a complete response compared to a CR rate of 37% in those treated after a period of observation. The median follow-up time is ten years. Continued follow-up may show a benefit for a subset of patients. The study has been closed to further patient accrual. Longer follow-up is necessary to determine if there is a survival difference between the different treatment approaches. Patients randomized to the WW arm will continue to be crossed over and treated per protocol. There have been no crossovers since the last report. - Human Subjects & Human Tissues, Fluids, Cells, etc.

Agency
National Institute of Health (NIH)
Institute
National Cancer Institute (NCI)
Type
Intramural Research (Z01)
Project #
1Z01SC009340-10
Application #
6290809
Study Section
Special Emphasis Panel (M)
Project Start
Project End
Budget Start
Budget End
Support Year
10
Fiscal Year
1999
Total Cost
Indirect Cost
Name
National Cancer Institute Division of Clinical Sciences
Department
Type
DUNS #
City
State
Country
United States
Zip Code