Combination Chemotherapy Followed By Radiation Therapy in... | NCT00053768 | Trialant
NCT00053768
Sponsor
German High-Grade Non-Hodgkin's Lymphoma Study Group
Status
Completed
Last Update Posted
May 18, 2021Actual
Enrollment
392Actual
Phase
Phase 3
Conditions
Lymphoma
Interventions
filgrastim
EPOCH regimen
cyclophosphamide
doxorubicin hydrochloride
etoposide
prednisone
vincristine sulfate
radiation therapy
Countries
Germany
Switzerland
Protocol Section
Identification Module
NCT ID
NCT00053768
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
CDR0000269371
Secondary IDs
ID
Type
Description
Link
DSHNHL-1999-2
EU-20242
Brief Title
Combination Chemotherapy Followed By Radiation Therapy in Treating Patients With Aggressive Non-Hodgkin's Lymphoma
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
Acronym
Not provided
Organization
Universität des SaarlandesOTHER
Status Module
Record Verification Date
May 2021
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Apr 2002
Primary Completion Date
Dec 5, 2006Actual
Completion Date
Dec 5, 2006Actual
First Submitted Date
Feb 5, 2003
First Submission Date that Met QC Criteria
Feb 5, 2003
First Posted Date
Feb 6, 2003Estimated
Results Waived
Not provided
Results First Submitted Date
Not provided
Results First Submitted that Met QC Criteria
Not provided
Results First Posted Date
Not provided
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
May 14, 2021
Last Update Posted Date
May 18, 2021Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
German High-Grade Non-Hodgkin's Lymphoma Study GroupOTHER
Collaborators
Not provided
Oversight Module
No data available
No data is available for this block.
Description Module
Brief 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.
Detailed 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 389 patients were accrued for this study.
Conditions Module
Conditions
Lymphoma
Keywords
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
Trumper L, Zwick C, Ziepert M, Hohloch K, Schmits R, Mohren M, Liersch R, Bentz M, Graeven U, Wruck U, Hoffmann M, Metzner B, Hasenclever D, Loeffler M, Pfreundschuh M; German High-Grade Non-Hodgkin's Lymphoma Study Group (DSHNHL). Dose-escalated CHOEP for the treatment of young patients with aggressive non-Hodgkin's lymphoma: I. A randomized dose escalation and feasibility study with bi- and tri-weekly regimens. Ann Oncol. 2008 Mar;19(3):538-44. doi: 10.1093/annonc/mdm497. Epub 2008 Jan 22.
Comprehensive Cancer Center Ulm at Universitaetsklinikum Ulm
Ulm
D-89081
Germany
Ev. Hospital Unna
Unna
D-59403
Germany
St. Marienhospital - Vechta
Vechta
D-49377
Germany
Klinikum Der Stadt Villingen - Schwenningen
Villingen-Schwenningen
D-78045
Germany
Regional Hospital Waldbrol
Waldbröl
D-51545
Germany
Hospital Wetzler
Wetzlar
D-35578
Germany
Deutsche Klinik fuer Diagnostik
Wiesbaden
D-65191
Germany
Dr. Horst-Schmidt-Kliniken
Wiesbaden
D-65199
Germany
Ev. Hospital Witten-Herdecke
Witten
D-58455
Germany
Kliniken St. Antonius
Wuppertal
D-42283
Germany
University Wurzburg
Würzburg
D-97070
Germany
Municipal Hospital Complex Zwickau
Zwickau
D-08060
Germany
UniversitaetsSpital Zuerich
Zurich
CH-8091
Switzerland
City Hospital Triemli
Zurich
D-8063
Switzerland
Result
Pfreundschuh M, Zwick C, Zeynalova S, Duhrsen U, Pfluger KH, Vrieling T, Mesters R, Mergenthaler HG, Einsele H, Bentz M, Lengfelder E, Trumper L, Rube C, Schmitz N, Loeffler M; German High-Grade Non-Hodgkin's Lymphoma Study Group (DSHNHL). Dose-escalated CHOEP for the treatment of young patients with aggressive non-Hodgkin's lymphoma: II. Results of the randomized high-CHOEP trial of the German High-Grade Non-Hodgkin's Lymphoma Study Group (DSHNHL). Ann Oncol. 2008 Mar;19(3):545-52. doi: 10.1093/annonc/mdm514. Epub 2007 Dec 6.