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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Faktisk)
Fas
- Fas 2
Kontakter och platser
Studieorter
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Antwerp, Belgien, 2020
- Ziekenhuis Network Antwerpen Middelheim
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Brussels, Belgien, B 1020
- Centre Hospitalier Universitaire Brugmann
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Leuven, Belgien, B-3000
- U.Z. Gasthuisberg
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Cairo, Egypten
- National Cancer Institute of Egypt
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Bayonne, Frankrike, F-64100
- Centre d'Oncologie du Pays-Basque
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Bordeaux, Frankrike, 33076
- Institut Bergonie
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Bordeaux, Frankrike, 33075
- Hopital Saint Andre
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Dax, Frankrike, 40107
- Centre Hospitalier de Dax
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Libourne, Frankrike, 33500
- Hôpital Robert Boulin
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Perigueux, Frankrike, 24004
- Polyclinique de Francheville
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Amsterdam, Nederländerna, 1091 HA
- Onze Lieve Vrouwe Gasthuis
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Groningen, Nederländerna, 9700 RB
- Academisch Ziekenhuis Groningen
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Nijmegen, Nederländerna, 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, Schweiz, CH-1226
- Hôpitaux Universitaires de Genève
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Dumfries, Storbritannien, DG1 4AP
- Dumfries Royal Infirmary
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England
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Wolverhampton, England, Storbritannien, WV10 0QP
- New Cross Hospital
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Maskning: Ingen (Open Label)
Samarbetspartners och utredare
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
- Immunsystemets sjukdomar
- Neoplasmer efter histologisk typ
- Neoplasmer
- Lymfoproliferativa störningar
- Lymfatiska sjukdomar
- Immunproliferativa störningar
- Lymfom
- Lymfom, icke-Hodgkin
- Läkemedels fysiologiska effekter
- Molekylära mekanismer för farmakologisk verkan
- Antiinflammatoriska medel
- Antireumatiska medel
- Antineoplastiska medel
- Immunsuppressiva medel
- Immunologiska faktorer
- Tubulin modulatorer
- Antimitotiska medel
- Mitosmodulatorer
- Glukokortikoider
- Hormoner
- Hormoner, hormonsubstitut och hormonantagonister
- Antineoplastiska medel, hormonella
- Antineoplastiska medel, Alkylering
- Alkyleringsmedel
- Myeloablativa agonister
- Antineoplastiska medel, fytogena
- Cyklofosfamid
- Prednison
- Vincristine
Andra studie-ID-nummer
- EORTC-20992
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