NCT00028691

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage cancer cells. It is not yet known if chlorambucil is more effective than radiation therapy in treating follicular lymphoma. PURPOSE: Randomized phase III trial to compare the effectiveness of chlorambucil with that of radiation therapy in treating patients who have stage III or stage IV follicular lymphoma that has not been previously treated.

Trial Health

60
Monitor

Trial Health Score

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

Geographic Reach
3 countries

11 active sites

Status
unknown

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

First Submitted

Initial submission to the registry

January 4, 2002

Completed
11 months until next milestone

Study Start

First participant enrolled

December 1, 2002

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
Last Updated

September 17, 2013

Status Verified

January 1, 2002

First QC Date

January 4, 2002

Last Update Submit

September 16, 2013

Conditions

Lymphoma

Keywords

stage III grade 1 follicular lymphomastage III grade 2 follicular lymphomastage III grade 3 follicular lymphomastage IV grade 1 follicular lymphomastage IV grade 2 follicular lymphomastage IV grade 3 follicular lymphoma

Interventions

chlorambucilDRUG
radiation therapyRADIATION

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Diagnosis of follicular lymphoma * Stage III or IV disease * Grades I, II, or III * Previously untreated disease * Nodal and extranodal sites * Bidimensionally measurable disease by physical examination or diagnostic imaging * No CNS or orbital non-Hodgkin's lymphoma localization PATIENT CHARACTERISTICS: Age: * 18 and over (for patients at EORTC centers) * 65 and over (for patients at HOVON centers) Performance status: * WHO 0-2 Life expectancy: * Not specified Hematopoietic: * WBC at least 4,000/mm\^3 * Platelet count at least 100,000/mm\^3 * Hemoglobin at least 6.0 g/dL Hepatic: * Not specified Renal: * Not specified Cardiovascular: * No severe cardiac disease that would preclude study treatment Pulmonary: * No severe pulmonary disease that would preclude study treatment Other: * HIV negative * No severe neurologic, psychiatric, or metabolic disease that would preclude study treatment * No other prior malignancy except basal cell skin cancer or carcinoma in situ of the cervix PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * Not specified Endocrine therapy: * No concurrent systemic corticosteroids, including dexamethasone for nausea and vomiting palliation (inhalation and topical corticosteroids allowed) Radiotherapy: * No concurrent elective radiotherapy to an adjacent negative lymph node 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 (11)

Algemeen Ziekenhuis Middelheim

Antwerp, 2020, Belgium

Location

Institut Gustave Roussy

Villejuif, F-94805, France

Location

Antoni van Leeuwenhoek Hospital

Amsterdam, 1066 CX, Netherlands

Location

Vrije Universiteit Medisch Centrum

Amsterdam, 1081HV, Netherlands

Location

Akademisch Medisch Centrum

Amsterdam, 1105 AZ, Netherlands

Location

Medisch Spectrum Twente

Enschede, 7500 KA, Netherlands

Location

Academisch Ziekenhuis Groningen

Groningen, 9713 EZ, Netherlands

Location

Maastro Clinic

Heerlen, NL-6401 PC, Netherlands

Location

Leiden University Medical Center

Leiden, 2300 RC, Netherlands

Location

Radiotherapeutisch Instituut Limburg-Maastricht

Maastricht, NL-6229 ET, Netherlands

Location

Daniel Den Hoed Cancer Center at Erasmus University Medical Center

Rotterdam, 3075 EA, Netherlands

Location

Related Publications (1)

  • Haas RL, Girinsky T. HOVON 47/EORTC 20013: chlorambucil vs 2x2 Gy involved field radiotherapy in stage III/IV previously untreated follicular lymphoma patients. Ann Hematol. 2003 Jul;82(7):458-62. doi: 10.1007/s00277-003-0655-8. Epub 2003 May 20. No abstract available.

    PMID: 12756499RESULT

MeSH Terms

Conditions

LymphomaLymphoma, Follicular

Interventions

ChlorambucilRadiotherapy

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesLymphoma, Non-Hodgkin

Intervention Hierarchy (Ancestors)

Nitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedHydrocarbonsOrganic ChemicalsTherapeutics

Study Officials

  • Rick L. M. Haas, MD

    The Netherlands Cancer Institute

  • T. Girinsky, MD

    Gustave Roussy, Cancer Campus, Grand Paris

Study Design

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

Study Record Dates

First Submitted

January 4, 2002

First Posted

January 27, 2003

Study Start

December 1, 2002

Last Updated

September 17, 2013

Record last verified: 2002-01

Locations

BE(1)FR(1)NL(9)