- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00039351
Combination Chemotherapy in Treating Older Patients With Non-Hodgkin's Lymphoma
Diffuse Large B Cell And Peripheral T-Cell Non-Hodgkin's Lymphoma In The Frail Elderly. Progressive And Cautious Treatment Strategy In Poor Status Patients. A Phase II Trial With Emphasis On Geriatric Assessment And Quality Of Life
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 may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating older patients who have non-Hodgkin's lymphoma.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
OBJECTIVES:
- 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.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Antwerp, Belgium, 2020
- Ziekenhuis Network Antwerpen Middelheim
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Brussels, Belgium, B 1020
- Centre Hospitalier Universitaire Brugmann
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Leuven, Belgium, B-3000
- U.Z. Gasthuisberg
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Cairo, Egypt
- National Cancer Institute of Egypt
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Bayonne, France, F-64100
- Centre d'Oncologie du Pays-Basque
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Bordeaux, France, 33076
- Institut Bergonié
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Bordeaux, France, 33075
- Hôpital Saint André
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Dax, France, 40107
- Centre Hospitalier de Dax
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Libourne, France, 33500
- Hôpital Robert Boulin
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Perigueux, France, 24004
- Polyclinique de Francheville
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Amsterdam, Netherlands, 1091 HA
- Onze Lieve Vrouwe Gasthuis
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Groningen, Netherlands, 9700 RB
- Academisch Ziekenhuis Groningen
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Nijmegen, Netherlands, NL-6500 HB
- University Medical Center Nijmegen
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Coimbra, Portugal, 3001-301
- Hospitais da Universidade de Coimbra (HUC)
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Thonex-Geneve, Switzerland, CH-1226
- Hôpitaux Universitaires de Genève
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Dumfries, United Kingdom, DG1 4AP
- Dumfries Royal Infirmary
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England
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Wolverhampton, England, United Kingdom, WV10 0QP
- New Cross Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
DISEASE CHARACTERISTICS:
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Masking: None (Open Label)
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Lymphatic Diseases
- Immunoproliferative Disorders
- Lymphoma
- Lymphoma, Non-Hodgkin
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Hormonal
- Antineoplastic Agents, Alkylating
- Alkylating Agents
- Myeloablative Agonists
- Antineoplastic Agents, Phytogenic
- Cyclophosphamide
- Prednisone
- Vincristine
Other Study ID Numbers
- EORTC-20992
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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