NCT00079261

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as cyclophosphamide, doxorubicin, vincristine, prednisone, and gemcitabine, work in different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one chemotherapy drug may kill more cancer cells. PURPOSE: This randomized phase II trial is studying giving combination chemotherapy together with gemcitabine to see how well it works compared to giving combination chemotherapy alone in treating patients with previously untreated aggressive stage II, stage III, or stage IV non-Hodgkin's lymphoma.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
25

participants targeted

Target at P25-P50 for phase_2 lymphoma

Geographic Reach
5 countries

6 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

January 1, 2004

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 8, 2004

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 10, 2004

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2007

Completed
Last Updated

September 24, 2012

Status Verified

September 1, 2012

Enrollment Period

3.2 years

First QC Date

March 8, 2004

Last Update Submit

September 20, 2012

Conditions

LymphomaSmall Intestine Cancer

Keywords

contiguous stage II grade 3 follicular lymphomanoncontiguous stage II grade 3 follicular lymphomastage III grade 3 follicular lymphomastage IV grade 3 follicular lymphomacontiguous stage II adult diffuse large cell lymphomanoncontiguous stage II adult diffuse large cell lymphomastage III adult diffuse large cell lymphomastage IV adult diffuse large cell lymphomaanaplastic large cell lymphomaangioimmunoblastic T-cell lymphomaadult grade III lymphomatoid granulomatosissmall intestine lymphoma

Outcome Measures

Primary Outcomes (1)

  • Complete response as assessed by Cheson criteria

Secondary Outcomes (3)

  • Toxicity as assessed by CTC 2.0

  • Proportion of courses given as scheduled

  • Freedom from treatment failure as assessed by Cheson criteria

Interventions

CHOP regimenDRUG
cyclophosphamideDRUG
doxorubicin hydrochlorideDRUG
gemcitabine hydrochlorideDRUG
prednisoneDRUG
vincristine sulfateDRUG

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically confirmed aggressive non-Hodgkin's lymphoma (NHL) of 1 of the following WHO subtypes: * Diffuse large B large cell lymphoma (including all clinical and morphologic variants) * Grade 3 follicular lymphoma * Extranodal T/NK cell lymphoma, nasal type * Enteropathy-type T cell lymphoma * Hepato-splenic T cell lymphoma * Peripheral T cell lymphoma, unspecified * Angioimmunoblastic lymphoma * Anaplastic large cell lymphoma, systemic type * Stage II-IV disease * At least 1 site of measurable disease (e.g., lymph node or lymph node mass) * The following subtypes are not allowed: * Mantle cell lymphoma * Burkitt's lymphoma * Precursor B or T cell lymphoma * Primary cutaneous B or T cell lymphoma * No CNS involvement by lymphoma PATIENT CHARACTERISTICS: Age * 18 to 70 Performance status * Not specified Life expectancy * Not specified Hematopoietic * WBC \> 3,000/mm\^3 * Neutrophil count \> 1,000/mm\^3 * Platelet count \> 100,000/mm\^3 Hepatic * Bilirubin \< 2.5 times normal (unless due to lymphoma) * ALT and AST \< 2.5 times normal (unless due to lymphoma) Renal * Creatinine \< 2.0 mg/dL Cardiovascular * No severe cardiac disease that would preclude study participation or limit life expectancy Pulmonary * FEV\_1 and DLCO ≥ 75% of predicted (unless due to lymphoma) * No severe pulmonary disease that would preclude study participation or limit life expectancy Other * Not pregnant or nursing * Fertile patients must use effective contraception * HIV negative * No other prior or concurrent malignancy except basal cell skin cancer or carcinoma in situ of the cervix * No severe neurologic or metabolic disease that would preclude study participation or limit life expectancy * No psychological, familial, sociological, or geographical condition that would preclude study compliance and follow-up PRIOR CONCURRENT THERAPY: Biologic therapy * No concurrent monoclonal antibodies Chemotherapy * No other concurrent chemotherapy Endocrine therapy * Not specified Radiotherapy * No prior radiotherapy * No concurrent radiotherapy Surgery * Not specified Other * No prior cytotoxic agents * No prior treatment for NHL * No other concurrent anticancer therapy * No other concurrent investigational drugs

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

Sponsors & Collaborators

Study Sites (6)

U.Z. Gasthuisberg

Leuven, B-3000, Belgium

Location

Algemeen Ziekenhuis Sint-Augustinus

Wilrijk, 2610, Belgium

Location

University Hospital Rebro

Zagreb, 41000, Croatia

Location

National Cancer Institute - Cairo

Cairo, Egypt

Location

Institut Bergonie

Bordeaux, 33076, France

Location

Universitair Medisch Centrum St. Radboud - Nijmegen

Nijmegen, NL-6500 HB, Netherlands

Location

Related Publications (1)

  • Aurer I, Eghbali H, Raemaekers J, Khaled HM, Fortpied C, Baila L, van der Maazen RW; EORTC Lymphoma Group. Gem-(R)CHOP versus (R)CHOP: a randomized phase II study of gemcitabine combined with (R)CHOP in untreated aggressive non-Hodgkin's lymphoma--EORTC lymphoma group protocol 20021 (EudraCT number 2004-004635-54). Eur J Haematol. 2011 Feb;86(2):111-6. doi: 10.1111/j.1600-0609.2010.01540.x. Epub 2010 Dec 22.

    PMID: 20942843RESULT

MeSH Terms

Conditions

LymphomaLymphoma, FollicularLymphoma, Large B-Cell, DiffuseLymphoma, Large-Cell, AnaplasticImmunoblastic Lymphadenopathy

Interventions

VAP-cyclo protocolCyclophosphamideDoxorubicinGemcitabinePrednisoneVincristine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Phosphoramide MustardsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedHydrocarbonsOrganic ChemicalsPhosphoramidesOrganophosphorus CompoundsDaunorubicinAnthracyclinesNaphthacenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicPolycyclic CompoundsAminoglycosidesGlycosidesCarbohydratesHeterocyclic CompoundsDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingPregnadienediolsPregnadienesPregnanesSteroidsFused-Ring CompoundsVinca AlkaloidsSecologanin Tryptamine AlkaloidsIndole AlkaloidsAlkaloidsIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingIndolizidinesIndolizines

Study Officials

  • Igor Aurer, MD, PhD

    University Hospital Rebro

    STUDY CHAIR

Study Design

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

Study Record Dates

First Submitted

March 8, 2004

First Posted

March 10, 2004

Study Start

January 1, 2004

Primary Completion

March 1, 2007

Last Updated

September 24, 2012

Record last verified: 2012-09

Locations

BE(2)CR(1)NL(1)FR(1)EG(1)