Chlorambucil Compared With No Further Therapy Following Anti-Helicobacter Therapy in Treating Patients With Low-Grade Lymphoma of the Stomach

NCT00003617 | Unknown Phase 3

• 3 other identifiers: CDR0000066695BNLI-LY03EU-98040
• Study Type: interventional
• Target: 200
• Locations: 5 countries
• Sites: 30

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. It is not yet known whether chlorambucil is more effective than observation in treating low-grade lymphoma of the stomach. PURPOSE: Randomized phase III trial to compare the effectiveness of chlorambucil with that of no further therapy following anti-Helicobacter therapy in treating patients with low-grade lymphoma of the stomach.

Conditions

Gastric Cancer

Keywords

stage I gastric cancer

Interventions

chlorambucil DRUG

clarithromycin DRUG

omeprazole DRUG

tinidazole DRUG

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: Endoscopically diagnosed, unresected, partially resected, or completely resected low grade (stage I) gastric lymphoma Prior diagnosis of H. pylori infection No nodal metastases Microbiological evidence of current H. pylori infection required No pathological evidence of enlarged abdominal lymph nodes by CT scan Gastroscopic ultrasound evidence of enlarged nodes allowed, if CT scan normal PATIENT CHARACTERISTICS: Age: 16 and over Performance status: Not specified Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Not specified Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: See Disease Characteristics

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

Sponsors & Collaborators

• Lymphoma Trials Office: lead

Study Sites (30)

Queen Mary Hospital

Hong Kong, Hong Kong

Location

Oncology Centre Institute

Warsaw, 02 781, Poland

Location

Frere Hospital

Central Region, South Africa

Location

Ospedale San Giovanni

Bellinzona, CH-6500, Switzerland

Location

Stoke Mandeville Hospital

Aylesbury-Buckinghamshire, England, HP21 8AL, United Kingdom

Location

Bradford Hospitals NHS Trust

Bradford, England, BD9 6RJ, United Kingdom

Location

Kent and Canterbury Hospital

Canterbury, England, CT2 7NR, United Kingdom

Location

Essex County Hospital

Colchester, England, United Kingdom

Location

Walsgrave Hospital

Coventry, England, CV2 2DX, United Kingdom

Location

Royal Free Hospital

Hampstead, London, England, NW3 2QG, United Kingdom

Location

Ipswich Hospital NHS Trust

Ipswich, England, IP4 5PD, United Kingdom

Location

Leeds Teaching Hospital Trust

Leeds, England, LS1 3EX, United Kingdom

Location

Charing Cross Hospital

London, England, W6 8RF, United Kingdom

Location

Middlesex Hospital- Meyerstein Institute

London, England, WIT 3AA, United Kingdom

Location

Clatterbridge Centre for Oncology NHS Trust

Merseyside, England, L63 4JY, United Kingdom

Location

Milton Keynes General Hospital

Milton Keynes, England, MK6 5LD, United Kingdom

Location

Mount Vernon Hospital

Northwood, England, HA6 2RN, United Kingdom

Location

Nottingham City Hospital NHS Trust

Nottingham, England, NG5 1PB, United Kingdom

Location

Peterborough Hospitals Trust

Peterborough, England, PE3 6DA, United Kingdom

Location

Salford Royal Hospitals NHS Trust

Salford, England, M6 8HD, United Kingdom

Location

Weston Park Hospital

Sheffield, England, S1O 2SJ, United Kingdom

Location

Royal Marsden Hospital

Sutton, England, SM2 5PT, United Kingdom

Location

Good Hope Hospital Trust

West Midlands, England, B75 7RR, United Kingdom

Location

Southend NHS Trust Hospital

Westcliff-on-Sea, England, United Kingdom

Location

York District Hospital

York, England, Y031 8HE, United Kingdom

Location

Kettering General Hosptial

Kettering, Northants, NNI6 8UZ, United Kingdom

Location

James Paget Hospital

Norfolk, NR31 6LA, United Kingdom

Location

Rotherham District General Hospital-NHS Trust

Rotherham, S60 2UD, United Kingdom

Location

Salisbury District Hospital

Salisbury, SP2 8BJ, United Kingdom

Location

Staffordshire General Hospital

Stafford, ST16 3SA, United Kingdom

Location

Related Publications (3)

• Hancock BW, Qian W, Linch D, Delchier JC, Smith P, Jakupovic I, Burton C, Souhami R, Wotherspoon A, Copie-Bergman C, Capella C, Traulle C, Levy M, Cortelazzo S, Ferreri AJ, Ambrosetti A, Pinotti G, Martinelli G, Vitolo U, Cavalli F, Gisselbrecht C, Zucca E. Chlorambucil versus observation after anti-Helicobacter therapy in gastric MALT lymphomas: results of the international randomised LY03 trial. Br J Haematol. 2009 Feb;144(3):367-75. doi: 10.1111/j.1365-2141.2008.07486.x. Epub 2008 Nov 22.

  PMID: 19036078 RESULT

• Bertoni F, Conconi A, Capella C, Motta T, Giardini R, Ponzoni M, Pedrinis E, Novero D, Rinaldi P, Cazzaniga G, Biondi A, Wotherspoon A, Hancock BW, Smith P, Souhami R, Cotter FE, Cavalli F, Zucca E; International Extranodal Lymphoma Study Group; United Kingdom Lymphoma Group. Molecular follow-up in gastric mucosa-associated lymphoid tissue lymphomas: early analysis of the LY03 cooperative trial. Blood. 2002 Apr 1;99(7):2541-4. doi: 10.1182/blood.v99.7.2541.

  PMID: 11895791 RESULT

• Zucca E, Roggero E, Delchier J, et al.: Interim evaluation of gastric malt lymphoma response to antibiotics in the ongoing LY03 randomized cooperative trial of observation vs chlorambucil after anti-helicobacter therapy. [Abstract] Proceedings of the American Society of Clinical Oncology 19: A12, 2000.

  RESULT

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Chlorambucil; Clarithromycin; Omeprazole; Tinidazole

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Erythromycin; Macrolides; Polyketides; Lactones; 2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Nitroimidazoles; Nitro Compounds; Imidazoles; Azoles

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

Study Record Dates

• First Submitted: November 1, 1999
• First Posted: March 12, 2004
• Study Start: March 1, 1995
• Last Updated: September 20, 2013

Record last verified: 2009-04

Locations

HK (1); PL (1); GB (26); ZA (1); CH (1)