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Combination Chemotherapy in Treating Older Patients With Non-Hodgkin's Lymphoma

20. september 2012 opdateret af: European Organisation for Research and Treatment of Cancer - EORTC

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.

Studieoversigt

Status

Afsluttet

Betingelser

Lymfom

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

Fase

Fase 2

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

Belgien
- - Antwerp, Belgien, 2020
    - Ziekenhuis Network Antwerpen Middelheim
  - Brussels, Belgien, B 1020
    - Centre Hospitalier Universitaire Brugmann
  - Leuven, Belgien, B-3000
    - U.Z. Gasthuisberg
Det Forenede Kongerige
- - Dumfries, Det Forenede Kongerige, DG1 4AP
    - Dumfries Royal Infirmary
- England
  - Wolverhampton, England, Det Forenede Kongerige, WV10 0QP
    - New Cross Hospital
Egypten
- - Cairo, Egypten
    - National Cancer Institute of Egypt
Frankrig
- - Bayonne, Frankrig, F-64100
    - Centre d'Oncologie du Pays-Basque
  - Bordeaux, Frankrig, 33076
    - Institut Bergonie
  - Bordeaux, Frankrig, 33075
    - Hopital Saint André
  - Dax, Frankrig, 40107
    - Centre Hospitalier de Dax
  - Libourne, Frankrig, 33500
    - Hôpital Robert Boulin
  - Perigueux, Frankrig, 24004
    - Polyclinique de Francheville
Holland
- - Amsterdam, Holland, 1091 HA
    - Onze Lieve Vrouwe Gasthuis
  - Groningen, Holland, 9700 RB
    - Academisch Ziekenhuis Groningen
  - Nijmegen, Holland, NL-6500 HB
    - University Medical Center Nijmegen
Portugal
- - Coimbra, Portugal, 3001-301
    - Hospitais da Universidade de Coimbra (HUC)
Schweiz
- - Thonex-Geneve, Schweiz, CH-1226
    - Hopitaux Universitaires de Geneve

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

70 år og ældre (Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Primært formål: Behandling
Maskning: Ingen (Åben etiket)

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

European Organisation for Research and Treatment of Cancer - EORTC

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. marts 2002

Primær færdiggørelse (Faktiske)

1. januar 2005

Datoer for studieregistrering

Først indsendt

6. juni 2002

Først indsendt, der opfyldte QC-kriterier

26. januar 2003

Først opslået (Skøn)

27. januar 2003

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

24. september 2012

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

20. september 2012

Sidst verificeret

1. september 2012

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

EORTC-20992

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .