NCT00003421

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known which chemotherapy regimen is more effective for advanced Hodgkin's disease. PURPOSE: Randomized phase III trial to compare different combination chemotherapy regimens in treating patients with advanced Hodgkin's disease.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
800

participants targeted

Target at P75+ for phase_3 lymphoma

Timeline
Completed

Started Jun 1998

Typical duration for phase_3 lymphoma

Geographic Reach
1 country

2 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

June 1, 1998

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed
4.4 years until next milestone

First Posted

Study publicly available on registry

March 12, 2004

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2005

Completed
Last Updated

December 4, 2013

Status Verified

May 1, 2007

First QC Date

November 1, 1999

Last Update Submit

December 3, 2013

Conditions

Lymphoma

Keywords

stage I adult Hodgkin lymphomastage II adult Hodgkin lymphomastage III adult Hodgkin lymphomastage IV adult Hodgkin lymphoma

Interventions

bleomycin sulfateBIOLOGICAL
ABVD regimenDRUG
chlorambucilDRUG
dacarbazineDRUG
doxorubicin hydrochlorideDRUG
etoposideDRUG
prednisoloneDRUG
procarbazine hydrochlorideDRUG
vinblastine sulfateDRUG
vincristine sulfateDRUG
radiation therapyRADIATION

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: Histologically confirmed advanced Hodgkin's disease requiring systemic therapy Stage IA or IIA disease with bulky disease or more than three sites of involvement are also eligible PATIENT CHARACTERISTICS: Age: Not specified Performance status: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: No other active malignancy within 5 years HIV negative Not pregnant or nursing Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy for Hodgkin's disease Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy for Hodgkin's disease Surgery: Not specified

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

Sponsors & Collaborators

Study Sites (2)

St. James's Hospital

Leeds, England, LS9 7TF, United Kingdom

Location

Weston Park Hospital

Sheffield, England, S1O 2SJ, United Kingdom

Location

Related Publications (1)

  • Johnson PW, Radford JA, Cullen MH, Sydes MR, Walewski J, Jack AS, MacLennan KA, Stenning SP, Clawson S, Smith P, Ryder D, Hancock BW; United Kingdom Lymphoma Group LY09 Trial (ISRCTN97144519). Comparison of ABVD and alternating or hybrid multidrug regimens for the treatment of advanced Hodgkin's lymphoma: results of the United Kingdom Lymphoma Group LY09 Trial (ISRCTN97144519). J Clin Oncol. 2005 Dec 20;23(36):9208-18. doi: 10.1200/JCO.2005.03.2151. Epub 2005 Nov 28.

    PMID: 16314615RESULT

MeSH Terms

Conditions

LymphomaHodgkin Disease

Interventions

BleomycinABVD protocolChlorambucilDacarbazineDoxorubicinEtoposidePrednisoloneProcarbazineVinblastineVincristineRadiotherapy

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

GlycopeptidesGlycoconjugatesCarbohydratesPeptidesAmino Acids, Peptides, and ProteinsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedHydrocarbonsOrganic ChemicalsTriazenesImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsDaunorubicinAnthracyclinesNaphthacenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicPolycyclic CompoundsAminoglycosidesGlycosidesPodophyllotoxinTetrahydronaphthalenesNaphthalenesGlucosidesPregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsBenzamidesAmidesBenzoatesAcids, CarbocyclicCarboxylic AcidsBenzene DerivativesVinca AlkaloidsSecologanin Tryptamine AlkaloidsIndole AlkaloidsAlkaloidsIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingIndolizidinesIndolizinesTherapeutics

Study Officials

  • Barry W. Hancock, MD

    Cancer Research Centre at Weston Park Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Purpose
TREATMENT
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

November 1, 1999

First Posted

March 12, 2004

Study Start

June 1, 1998

Study Completion

November 1, 2005

Last Updated

December 4, 2013

Record last verified: 2007-05

Locations

GB(2)