Combination Chemotherapy in Treating Older Patients With Non-Hodgkin's Lymphoma
- Conditions
- Lymphoma
- Registration Number
- NCT00039351
- Lead Sponsor
- European Organisation for Research and Treatment of Cancer - EORTC
- Brief Summary
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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 32
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (17)
Academisch Ziekenhuis Groningen
🇳🇱Groningen, Netherlands
Ziekenhuis Network Antwerpen Middelheim
🇧🇪Antwerp, Belgium
Centre Hospitalier Universitaire Brugmann
🇧🇪Brussels, Belgium
National Cancer Institute of Egypt
🇪🇬Cairo, Egypt
U.Z. Gasthuisberg
🇧🇪Leuven, Belgium
University Medical Center Nijmegen
🇳🇱Nijmegen, Netherlands
Hospitais da Universidade de Coimbra (HUC)
🇵🇹Coimbra, Portugal
Hopitaux Universitaires de Geneve
🇨ðŸ‡Thonex-Geneve, Switzerland
Hopital Saint Andre
🇫🇷Bordeaux, France
Centre D'Oncologie Du Pays-Basque
🇫🇷Bayonne, France
Centre Hospitalier de Dax
🇫🇷Dax, France
Onze Lieve Vrouwe Gasthuis
🇳🇱Amsterdam, Netherlands
Polyclinique de Francheville
🇫🇷Perigueux, France
Institut Bergonie
🇫🇷Bordeaux, France
Hopital Robert Boulin
🇫🇷Libourne, France
New Cross Hospital
🇬🇧Wolverhampton, England, United Kingdom
Dumfries Royal Infirmary
🇬🇧Dumfries, United Kingdom