Combination Chemotherapy in Treating Older Patients With Non-Hodgkin's Lymphoma
NCT ID: NCT00039351
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
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COMPLETED
PHASE2
32 participants
INTERVENTIONAL
2002-03-31
Brief Summary
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PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating older patients who have non-Hodgkin's lymphoma.
Detailed Description
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* Determine the complete remission (CR) rate and duration of CR in frail elderly patients with diffuse large B-cell or peripheral T-cell non-Hodgkin's lymphoma treated with cyclophosphamide, vincristine, and prednisone.
* Determine the time to progression and overall survival of patients treated with this regimen.
* Determine the severe toxicity rate of this regimen in these patients.
* Assess the quality of life of patients treated with this regimen.
OUTLINE: This is a multicenter study.
Patients receive cyclophosphamide IV and vincristine IV on day 1 and oral prednisone on days 1-5. Treatment repeats every 3 weeks for 3 courses in the absence of disease progression or unacceptable toxicity.
Patients with stage I or II non-Hodgkin's lymphoma (NHL), no baseline lactate dehydrogenase (LDH) elevation, baseline WHO performance status 0-1, and longest tumor diameter of less than 5 cm, who achieve partial response (PR) or complete response (CR), receive 1 additional course of chemotherapy. Patients then undergo involved-field radiotherapy once daily 5 days a week for 3.5-4 weeks.
Patients with stage I or II NHL, a baseline LDH elevation, and/or baseline WHO performance status 2-4, and/or longest tumor diameter of at least 5 cm, who achieve PR or CR, receive 3 additional courses of chemotherapy. Patients then undergo involved-field radiotherapy once daily 5 days a week for 3.5-4 weeks.
Patients with stage III or IV NHL who achieve CR or PR receive 3 additional courses of chemotherapy. Patients then undergo consolidative radiotherapy once daily 5 days a week for 2.5-3 weeks.
Quality of life is assessed at baseline, after the third chemotherapy course, 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 29-56 patients will be accrued for this study within 12-18 months.
Conditions
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Keywords
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Study Design
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TREATMENT
NONE
Interventions
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cyclophosphamide
prednisone
vincristine sulfate
radiation therapy
Eligibility Criteria
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Inclusion Criteria
* Diagnosis of diffuse large B-cell or peripheral T-cell non-Hodgkin's lymphoma (NHL)
* No Burkitt's-like lymphoma
* Small cells in bone marrow allowed
* Previously untreated NHL
* At least 1 measurable lesion
* At least 1.1 cm
* Poor physiological status with at least 1 of the following:
* WHO performance status of 3-4
* LVEF less than 50%
* Creatinine clearance less than 50 mL/min
* Neutrophil count no greater than 1,500/mm\^3
* Platelet count no greater than 100,000/mm\^3
* Concurrent severe disease that would preclude cyclophosphamide, vincristine, prednisolone, and doxorubicin
* No cerebral or meningeal involvement
PATIENT CHARACTERISTICS:
Age:
* 70 and over
Performance status:
* See Disease Characteristics
Life expectancy:
* Not specified
Hematopoietic:
* See Disease Characteristics
Hepatic:
* Not specified
Renal:
* See Disease Characteristics
Other:
* HIV negative
* No other malignancy within the past 5 years except adequately treated basal cell skin cancer, curatively treated carcinoma in situ of the cervix, or curatively treated solid tumor
* No active infection
* No psychological, familial, sociological, or geographical condition that would preclude study participation
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* Not specified
Chemotherapy:
* See Disease Characteristics
Endocrine therapy:
* Not specified
Radiotherapy:
* Not specified
Surgery:
* Not specified
Other:
* No other concurrent investigational drugs
* No other concurrent antineoplastic agents
70 Years
ALL
No
Sponsors
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European Organisation for Research and Treatment of Cancer - EORTC
NETWORK
Responsible Party
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Principal Investigators
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Pierre Soubeyran, MD, PhD
Role: STUDY_CHAIR
Institut Bergonié
Locations
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Ziekenhuis Network Antwerpen Middelheim
Antwerp, , Belgium
Centre Hospitalier Universitaire Brugmann
Brussels, , Belgium
U.Z. Gasthuisberg
Leuven, , Belgium
National Cancer Institute of Egypt
Cairo, , Egypt
Centre D'Oncologie Du Pays-Basque
Bayonne, , France
Hopital Saint Andre
Bordeaux, , France
Institut Bergonie
Bordeaux, , France
Centre Hospitalier de Dax
Dax, , France
Hopital Robert Boulin
Libourne, , France
Polyclinique de Francheville
Périgueux, , France
Onze Lieve Vrouwe Gasthuis
Amsterdam, , Netherlands
Academisch Ziekenhuis Groningen
Groningen, , Netherlands
University Medical Center Nijmegen
Nijmegen, , Netherlands
Hospitais da Universidade de Coimbra (HUC)
Coimbra, , Portugal
Hopitaux Universitaires de Geneve
Thonex-Geneve, , Switzerland
New Cross Hospital
Wolverhampton, England, United Kingdom
Dumfries Royal Infirmary
Dumfries, , United Kingdom
Countries
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Other Identifiers
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EORTC-20992
Identifier Type: -
Identifier Source: secondary_id
EORTC-20992
Identifier Type: -
Identifier Source: org_study_id