Diffuse Large B Cell And Peripheral T Cell Non-Hodgkin's Lymphomas (NHL) In The Elderly. Influence Of Prolonged Oral Etoposide Added To CHOP Combination Chemotherapy In Patients With Good Physiological Status. An EORTC Randomized Phase II-III Trial Including Geriatric Assessment And Quality Of Life
OBJECTIVES:
- Compare the complete response rates in older patients with diffuse large B-cell or
peripheral T-cell non-Hodgkin's lymphoma treated with cyclophosphamide, doxorubicin,
vincristine, and prednisone (CHOP) with vs without etoposide.
- Compare the overall survival of patients treated with these regimens.
- Compare the time to treatment failure in patients treated with these regimens.
- Compare the freedom from progression in patients treated with these regimens.
- Determine the toxicity of CHOP plus etoposide in these patients.
- Compare the quality of life of patients treated with these regimens.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to
cellular type (B-cell vs T-cell), initial stage of disease (I and II vs III and IV), WHO
performance status (0-1 vs 2), and lactic dehydrogenase level (LDH) (normal vs abnormal).
Patients are randomized to 1 of 2 treatment arms.
- Arm I (CHOP chemotherapy): Patients receive cyclophosphamide IV, doxorubicin IV, and
vincristine IV on day 1. Patients also receive oral prednisone on days 1-5. Treatment
repeats every 21 days for 3 courses in the absence of unacceptable toxicity. Patients
then undergo disease evaluation.
Patients with disease progression or no change in disease are removed from study. Patients
with responsive stage I or II disease receive 1 additional course if they demonstrate all 3
of the following conditions (at baseline): no LDH elevation, WHO performance status of 0-1,
and greatest single diameter of any tumor site less than 5 cm. Patients with responsive
stage I or II disease receive 3 additional courses if they demonstrate 1 or more of the
following conditions (at baseline): LDH elevation, WHO performance status 2, and/or greatest
single diameter of any tumor site at least 5 cm. Patients with responsive stage III or IV
disease receive 3 additional courses.
After the completion of chemotherapy, patients with responsive stage I or II disease undergo
involved field radiotherapy once daily 5 days a week for 3.5-4 weeks. Patients with initial
bulky stage III or IV disease may also undergo radiotherapy.
- Arm II (CHOP chemotherapy and etoposide): Patients receive CHOP chemotherapy as in arm
I plus oral etoposide 2 or 3 times daily on days 1-10. Treatment repeats every 21 days
for 3 courses in the absence of unacceptable toxicity. Patients receive additional
courses as in arm I.
After the completion of chemotherapy, patients with responsive stage I or II disease or
initial bulky stage III or IV disease undergo radiotherapy as in arm I.
Quality of life is assessed at baseline, after course 3, at the end of chemotherapy, every 6
months for 3 years, and then annually thereafter.
Patients are followed every 3 months for 3 years, every 6 months for 2 years, and then
annually thereafter.
PROJECTED ACCRUAL: A total of 686 patients (126 for phase II and 560 for phase III) will be
accrued for this study within 5 years.
Interventional
Allocation: Randomized, Primary Purpose: Treatment
Pierre Soubeyran, MD, PhD
Study Chair
Institut BergoniƩ
United States: Federal Government
EORTC-20991
NCT00060385
March 2003
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