Combination Chemotherapy With or Without Etoposide in Treating Older Patients With Non-Hodgkin's Lymphoma
NCT ID: NCT00060385
Last Updated: 2012-09-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
TERMINATED
PHASE2/PHASE3
3 participants
INTERVENTIONAL
2003-03-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
* 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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
TREATMENT
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
CHOP regimen
EPOCH regimen
cyclophosphamide
doxorubicin hydrochloride
etoposide
prednisone
vincristine sulfate
radiation therapy
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Diagnosis of diffuse large B-cell\* or peripheral T-cell non-Hodgkin's lymphoma by REAL/WHO classification, including the following:
* All morphological and clinical variants
* All Ann Arbor stages NOTE: \*Presence of a small cell, indolent lymphoma component in the bone marrow biopsy is allowed
* No Burkitt-like lymphoma
* Previously untreated disease
* No cerebral or meningeal involvement
* At least 1 measurable target lesion at least 1.1 cm by the Cheson criteria
PATIENT CHARACTERISTICS:
Age
* 70 and over
Performance status
* WHO 0-2
Life expectancy
* Not specified
Hematopoietic
* Absolute neutrophil count greater than 1,500/mm\^3
* Platelet count greater than 100,000/mm\^3 (unless related to bone marrow infiltration)
Hepatic
* Bilirubin less than 1.8 mg/dL\*
* AST or ALT less than 2.5 times upper limit of normal (ULN)\*
* Alkaline phosphatase less than 4 times ULN\* NOTE: \*Values above these thresholds are allowed only if related to non-Hodgkin's lymphoma
Renal
* Creatinine clearance at least 50 mL/min
Cardiovascular
* LVEF at least 50%
Other
* HIV negative
* No history of concurrent severe disease that would preclude study treatment
* No other prior or concurrent malignancy except adequately treated basal cell skin cancer, curatively treated carcinoma in situ of the cervix, or other curatively treated solid malignancy with no evidence of disease for at least 5 years prior to study entry
* No psychological, familial, sociological, or geographical condition that would preclude study compliance and follow-up
PRIOR CONCURRENT THERAPY:
Biologic therapy
* Not specified
Chemotherapy
* Not specified
Endocrine therapy
* Not specified
Radiotherapy
* Not specified
Surgery
* Not specified
Other
* No concurrent participation in another investigational drug study
* No other concurrent antineoplastic agents
70 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
European Organisation for Research and Treatment of Cancer - EORTC
NETWORK
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Pierre Soubeyran, MD, PhD
Role: STUDY_CHAIR
Institut Bergonié
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
U.Z. Gasthuisberg
Leuven, , Belgium
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
EORTC-20991
Identifier Type: -
Identifier Source: secondary_id
EORTC-20991
Identifier Type: -
Identifier Source: org_study_id