A Phase III Study of Involved Field Radiation Therapy (IFRT) in Patients With Histologically Aggressive Non-Hodgkin's Lymphoma Following High Dose Chemotherapy and Autologous Hematopoietic Stem Cell Transplantation (ASCT)
- Compare the 3-year progression-free survival of patients with relapsed or refractory
aggressive non-Hodgkin's 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 (complete/unconfirmed 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 4.2 years.
Allocation: Randomized, Primary Purpose: Treatment
Richard Tsang, MD, FRCPC
Princess Margaret Hospital, Canada
United States: Federal Government