Overview

This trial is active, not recruiting.

Condition lymphoma
Treatments filgrastim, epoch regimen, cyclophosphamide, doxorubicin hydrochloride, etoposide, prednisone, vincristine sulfate, radiation therapy
Phase phase 3
Sponsor German High-Grade Non-Hodgkin's Lymphoma Study Group
Start date April 2002
Trial size 552 participants
Trial identifier NCT00053768, CDR0000269371, DSHNHL-1999-2, EU-20242

Summary

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 and giving the drugs in different ways may kill more cancer cells. Radiation therapy uses high-energy x-rays to damage cancer cells. It is not yet known which combination chemotherapy regimen followed by radiation therapy is more effective in treating aggressive non-Hodgkin's lymphoma.

PURPOSE: This randomized phase III trial is studying two combination chemotherapy regimens followed by radiation therapy to compare how well they work in treating patients with aggressive non-Hodgkin's lymphoma.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Masking open label
Primary purpose treatment

Primary Outcomes

Measure
Time to treatment failure (TTF) at first relapse, 3 years within study and periodically after study completion
time frame:

Secondary Outcomes

Measure
Complete response rate at first relapse, 3 years within study and periodically after study completion
time frame:
Survival time
time frame:
Tumor control
time frame:
Disease-free survival
time frame:

Eligibility Criteria

Male or female participants from 18 years up to 60 years old.

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

Additional Information

Official title 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
Description 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.
Trial information was received from ClinicalTrials.gov and was last updated in February 2009.
Information provided to ClinicalTrials.gov by National Cancer Institute (NCI).