NCT00039351

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for phase_2 lymphoma

Geographic Reach
7 countries

17 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2002

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 6, 2002

Completed
8 months until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2005

Completed
Last Updated

September 24, 2012

Status Verified

September 1, 2012

Enrollment Period

2.8 years

First QC Date

June 6, 2002

Last Update Submit

September 20, 2012

Conditions

Lymphoma

Keywords

stage I adult diffuse large cell lymphomastage III adult diffuse large cell lymphomastage IV adult diffuse large cell lymphomacontiguous stage II adult diffuse large cell lymphomanoncontiguous stage II adult diffuse large cell lymphomaangioimmunoblastic T-cell lymphoma

Interventions

cyclophosphamideDRUG
prednisoneDRUG
vincristine sulfateDRUG
radiation therapyRADIATION

Eligibility Criteria

Age70 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (17)

Ziekenhuis Network Antwerpen Middelheim

Antwerp, 2020, Belgium

Location

Centre Hospitalier Universitaire Brugmann

Brussels, B 1020, Belgium

Location

U.Z. Gasthuisberg

Leuven, B-3000, Belgium

Location

National Cancer Institute of Egypt

Cairo, Egypt

Location

Centre D'Oncologie Du Pays-Basque

Bayonne, F-64100, France

Location

Hopital Saint Andre

Bordeaux, 33075, France

Location

Institut Bergonie

Bordeaux, 33076, France

Location

Centre Hospitalier de Dax

Dax, 40107, France

Location

Hopital Robert Boulin

Libourne, 33500, France

Location

Polyclinique de Francheville

Périgueux, 24004, France

Location

Onze Lieve Vrouwe Gasthuis

Amsterdam, 1091 HA, Netherlands

Location

Academisch Ziekenhuis Groningen

Groningen, 9700 RB, Netherlands

Location

University Medical Center Nijmegen

Nijmegen, NL-6500 HB, Netherlands

Location

Hospitais da Universidade de Coimbra (HUC)

Coimbra, 3001-301, Portugal

Location

Hopitaux Universitaires de Geneve

Thonex-Geneve, CH-1226, Switzerland

Location

New Cross Hospital

Wolverhampton, England, WV10 0QP, United Kingdom

Location

Dumfries Royal Infirmary

Dumfries, DG1 4AP, United Kingdom

Location

MeSH Terms

Conditions

LymphomaLymphoma, Large B-Cell, DiffuseImmunoblastic Lymphadenopathy

Interventions

CyclophosphamidePrednisoneVincristineRadiotherapy

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesLymphoma, B-CellLymphoma, Non-HodgkinLymphadenopathy

Intervention Hierarchy (Ancestors)

Phosphoramide MustardsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedHydrocarbonsOrganic ChemicalsPhosphoramidesOrganophosphorus CompoundsPregnadienediolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsVinca AlkaloidsSecologanin Tryptamine AlkaloidsIndole AlkaloidsAlkaloidsHeterocyclic CompoundsIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingIndolizidinesIndolizinesTherapeutics

Study Officials

  • Pierre Soubeyran, MD, PhD

    Institut Bergonié

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Masking
NONE
Purpose
TREATMENT
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 6, 2002

First Posted

January 27, 2003

Study Start

March 1, 2002

Primary Completion

January 1, 2005

Last Updated

September 24, 2012

Record last verified: 2012-09

Locations

NL(3)BE(3)GB(2)CH(1)PT(1)EG(1)FR(6)