Combination Chemotherapy in Treating Older Patients With Non-Hodgkin's Lymphoma
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.
|Lymphoma||Drug: cyclophosphamide Drug: prednisone Drug: vincristine sulfate Radiation: radiation therapy||Phase 2|
|Study Design:||Masking: Open Label
Primary Purpose: Treatment
|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|
|Primary Completion Date:||January 2005 (Final data collection date for primary outcome measure)|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00039351
|Ziekenhuis Network Antwerpen Middelheim|
|Antwerp, Belgium, 2020|
|Centre Hospitalier Universitaire Brugmann|
|Brussels, Belgium, B 1020|
|Leuven, Belgium, B-3000|
|National Cancer Institute of Egypt|
|Centre D'Oncologie Du Pays-Basque|
|Bayonne, France, F-64100|
|Hopital Saint Andre|
|Bordeaux, France, 33075|
|Bordeaux, France, 33076|
|Centre Hospitalier de Dax|
|Dax, France, 40107|
|Hopital Robert Boulin|
|Libourne, France, 33500|
|Polyclinique de Francheville|
|Perigueux, France, 24004|
|Onze Lieve Vrouwe Gasthuis|
|Amsterdam, Netherlands, 1091 HA|
|Academisch Ziekenhuis Groningen|
|Groningen, Netherlands, 9700 RB|
|University Medical Center Nijmegen|
|Nijmegen, Netherlands, NL-6500 HB|
|Hospitais da Universidade de Coimbra (HUC)|
|Coimbra, Portugal, 3001-301|
|Hopitaux Universitaires de Geneve|
|Thonex-Geneve, Switzerland, CH-1226|
|New Cross Hospital|
|Wolverhampton, England, United Kingdom, WV10 0QP|
|Dumfries Royal Infirmary|
|Dumfries, United Kingdom, DG1 4AP|
|Study Chair:||Pierre Soubeyran, MD, PhD||Institut Bergonié|