Combination Chemotherapy With or Without Etoposide in Treating Older Patients With Non-Hodgkin's Lymphoma
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells. It is not yet known which combination chemotherapy regimen is more effective in treating non-Hodgkin's lymphoma.
PURPOSE: Randomized phase II/III trial to compare the effectiveness of combination chemotherapy with or without etoposide in treating older patients who have non-Hodgkin's lymphoma that has not been previously treated.
|Lymphoma||Drug: CHOP regimen Drug: EPOCH regimen Drug: cyclophosphamide Drug: doxorubicin hydrochloride Drug: etoposide Drug: prednisone Drug: vincristine sulfate Radiation: radiation therapy||Phase 2 Phase 3|
|Study Design:||Allocation: Randomized
Primary Purpose: Treatment
|Official Title:||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|
|Study Start Date:||March 2003|
|Primary Completion Date:||August 2004 (Final data collection date for primary outcome measure)|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00060385
|Leuven, Belgium, B-3000|
|Study Chair:||Pierre Soubeyran, MD, PhD||Institut Bergonié|