Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsored by: |
European Organization for Research and Treatment of Cancer |
---|---|
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00039351 |
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.
Condition | Intervention | Phase |
---|---|---|
Lymphoma |
Drug: cyclophosphamide Drug: prednisone Drug: vincristine sulfate Radiation: radiation therapy |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | 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 |
Study Start Date: | March 2002 |
OBJECTIVES:
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.
Ages Eligible for Study: | 70 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of diffuse large B-cell or peripheral T-cell non-Hodgkin's lymphoma (NHL)
At least 1 measurable lesion
Poor physiological status with at least 1 of the following:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Belgium | |
Centre Hospitalier Universitaire Brugmann | |
Brussels, Belgium, B 1020 | |
U.Z. Gasthuisberg | |
Leuven, Belgium, B-3000 | |
Ziekenhuis Network Antwerpen Middelheim | |
Antwerp, Belgium, 2020 | |
Egypt | |
National Cancer Institute of Egypt | |
Cairo, Egypt | |
France | |
Hopital Saint Andre | |
Bordeaux, France, 33075 | |
Centre Hospitalier de Dax | |
Dax, France, 40107 | |
Hopital Robert Boulin | |
Libourne, France, 33500 | |
Centre D'Oncologie Du Pays-Basque | |
Bayonne, France, F-64100 | |
Institut Bergonie | |
Bordeaux, France, 33076 | |
Polyclinique de Francheville | |
Perigueux, France, 24004 | |
Netherlands | |
Academisch Ziekenhuis Groningen | |
Groningen, Netherlands, 9700 RB | |
Onze Lieve Vrouwe Gasthuis | |
Amsterdam, Netherlands, 1091 HA | |
University Medical Center Nijmegen | |
Nijmegen, Netherlands, NL-6500 HB | |
Portugal | |
Hospitais da Universidade de Coimbra (HUC) | |
Coimbra, Portugal, 3001-301 | |
Switzerland | |
Hopitaux Universitaires de Geneve | |
Thonex-Geneve, Switzerland, CH-1226 | |
United Kingdom | |
Dumfries Royal Infirmary | |
Dumfries, United Kingdom, DG1 4AP | |
United Kingdom, England | |
New Cross Hospital | |
Wolverhampton, England, United Kingdom, WV10 0QP |
Investigator: | Pierre Soubeyran, MD, PhD | Institut Bergonie |
Study ID Numbers: | CDR0000069376, EORTC-20992 |
Study First Received: | June 6, 2002 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00039351 History of Changes |
Health Authority: | United States: Federal Government |
stage I adult diffuse large cell lymphoma stage III adult diffuse large cell lymphoma stage IV adult diffuse large cell lymphoma |
contiguous stage II adult diffuse large cell lymphoma noncontiguous stage II adult diffuse large cell lymphoma angioimmunoblastic T-cell lymphoma |
Anti-Inflammatory Agents Prednisone Immunologic Factors Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Quality of Life Cyclophosphamide Hormones Lymphoma, Small Cleaved-cell, Diffuse Lymphoma, T-Cell Lymphoma, Large-cell Lymphoma Alkylating Agents Lymphoma, Large B-Cell, Diffuse |
Immunoproliferative Disorders Antineoplastic Agents, Hormonal Immunoblastic Lymphadenopathy Vincristine Antimitotic Agents Immunosuppressive Agents Glucocorticoids Lymphatic Diseases Tubulin Modulators Antineoplastic Agents, Alkylating Lymphoproliferative Disorders Lymphoma, Non-Hodgkin Antirheumatic Agents Antineoplastic Agents, Phytogenic |
Anti-Inflammatory Agents Prednisone Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Cyclophosphamide Hormones Therapeutic Uses Lymphoma Alkylating Agents Immunoproliferative Disorders Neoplasms by Histologic Type Antineoplastic Agents, Hormonal |
Immune System Diseases Mitosis Modulators Vincristine Antimitotic Agents Immunosuppressive Agents Glucocorticoids Pharmacologic Actions Lymphatic Diseases Neoplasms Tubulin Modulators Myeloablative Agonists Antineoplastic Agents, Alkylating Lymphoproliferative Disorders Lymphoma, Non-Hodgkin Antirheumatic Agents |