Randomised Trial Comparing Chemotherapy Mit CHOEP (Cyclophosphamid, Doxorubicin, Vincristin, Etoposid Und Prednison) In 21-Day Intervals In Standard And Escalated Doses In Patients Aged 18-60 Years Of Age With Aggresive Non-Hodgkin-Lymphomas Favourable Prognoses
18 Years
60 Years
Both
Lymphoma
Trial Information
Randomised Trial Comparing Chemotherapy Mit CHOEP (Cyclophosphamid, Doxorubicin, Vincristin, Etoposid Und Prednison) In 21-Day Intervals In Standard And Escalated Doses In Patients Aged 18-60 Years Of Age With Aggresive Non-Hodgkin-Lymphomas Favourable Prognoses
OBJECTIVES:
- Compare the efficacy of standard-dose vs high-dose cyclophosphamide, doxorubicin,
vincristine, etoposide, and prednisone followed by radiotherapy, in terms of time to
treatment failure, in patients with aggressive non-Hodgkin's lymphoma.
- Compare the acute and long-term toxic effects of these regimens in these patients.
- Compare the complete response rate, survival and tumor control, and disease-free
survival in patients treated with these regimens.
- Analyze the time to relapse after radiotherapy in these patients.
OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified
according to LDH levels (no greater than upper limit of normal [ULN] vs greater than ULN),
initial bulky disease (yes vs no), stage (I or II vs II or IV), ECOG performance status (0
or 1 vs 2 or 3), and participating center. Patients are randomized to 1 of 2 treatment arms
as follows:
- Arm I (Standard dose): Patients receive cyclophosphamide IV, doxorubicin IV, and
vincristine IV on day 1; etoposide IV on days 1-3; and oral prednisone on days 1-5
(CHOEP) in standard doses.
- Arm II (Escalated dose): Patients receive high-dose CHOEP as in arm I. Patients also
receive filgrastim (G-CSF) subcutaneously on days 6-12.
In both arms, treatment repeats every 21 days for up to 6 courses in the absence of disease
progression or unacceptable toxicity.
After completion of CHOEP chemotherapy, patients with initial bulky disease or extranodal
involvement undergo radiotherapy 5 days a week for 4 weeks.
Patients who undergo radiotherapy are followed at 2 months after radiotherapy. All patients
(including those who undergo radiotherapy) are followed every 3 months for 2 years and then
every 6 months for 3 years.
PROJECTED ACCRUAL: A total of 552 patients were accrued for this study within 4.75 years.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Histologically confirmed aggressive non-Hodgkin's lymphoma
- Previously untreated disease
- Favorable prognosis
- International Prognostic Index score of 0-1
- No more than 25% marrow involvement
PATIENT CHARACTERISTICS:
Age
- 18 to 60
Performance status
- ECOG 0-3 OR
- Karnofsky 40-100%
Life expectancy
- Not specified
Hematopoietic
- Platelet count at least 100,000/mm^3
- WBC at least 2,500/mm^3
Hepatic
- No active hepatitis infection
Renal
- Not specified
Other
- HIV negative
- Not pregnant or nursing
- No relevant accompanying disease
- No other concurrent malignancy
- No contraindications to any study medications
- No prior noncompliance by patient
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- No prior chemotherapy
Endocrine therapy
- Not specified
Radiotherapy
- No prior radiotherapy
Surgery
- Not specified
Other
- No other concurrent participation in another treatment study
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Time to treatment failure (TTF) at first relapse, 3 years within study and periodically after study completion
Safety Issue:
No
Principal Investigator
Michael G.M. Pfreundschuh, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Universitaetsklinikum des Saarlandes
Authority:
United States: Federal Government
Study ID:
CDR0000269371
NCT ID:
NCT00053768
Start Date:
April 2002
Completion Date:
Related Keywords:
- Lymphoma
- contiguous stage II grade 3 follicular lymphoma
- noncontiguous stage II grade 3 follicular lymphoma
- stage I grade 3 follicular lymphoma
- stage III grade 3 follicular lymphoma
- stage IV grade 3 follicular lymphoma
- contiguous stage II adult diffuse mixed cell lymphoma
- noncontiguous stage II adult diffuse mixed cell lymphoma
- stage I adult diffuse mixed cell lymphoma
- stage III adult diffuse mixed cell lymphoma
- stage IV adult diffuse mixed cell lymphoma
- contiguous stage II adult diffuse large cell lymphoma
- contiguous stage II adult Burkitt lymphoma
- noncontiguous stage II adult diffuse large cell lymphoma
- noncontiguous stage II adult Burkitt lymphoma
- stage I adult diffuse large cell lymphoma
- stage I adult Burkitt lymphoma
- stage III adult diffuse large cell lymphoma
- stage III adult Burkitt lymphoma
- stage IV adult diffuse large cell lymphoma
- stage IV adult Burkitt lymphoma
- contiguous stage II adult immunoblastic large cell lymphoma
- noncontiguous stage II adult immunoblastic large cell lymphoma
- stage I adult immunoblastic large cell lymphoma
- stage III adult immunoblastic large cell lymphoma
- stage IV adult immunoblastic large cell lymphoma
- contiguous stage II adult lymphoblastic lymphoma
- noncontiguous stage II adult lymphoblastic lymphoma
- stage I adult lymphoblastic lymphoma
- stage III adult lymphoblastic lymphoma
- stage IV adult lymphoblastic lymphoma
- contiguous stage II mantle cell lymphoma
- noncontiguous stage II mantle cell lymphoma
- stage I mantle cell lymphoma
- stage III mantle cell lymphoma
- stage IV mantle cell lymphoma
- Lymphoma
- Lymphoma, Non-Hodgkin
- Lymphoma, Large-Cell, Immunoblastic
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