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

Gastric Cancer Clinical Trial

Official title:

Protocol for a Randomised Trial of Observation Versus Chlorambucil After Anti-Helicobacter Therapy in Low Grade Gastric Lymphoma

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00003617
• Other study ID #: CDR0000066695
• Secondary ID: BNLI-LY03EU-9804
• Status: Active, not recruiting
• Phase: Phase 3
• First received: November 1, 1999
• Last updated: September 19, 2013
• Start date: March 1995

Study information

• Verified date: April 2009
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

Description:

OBJECTIVES: I. Determine the efficacy and response rate of triple antibiotic therapy for Helicobacter pylori in the healing of lesions in patients with low grade gastric lymphoma. II. Assess the efficacy of chlorambucil in the prevention of relapse in patients after complete eradication of low grade gastric lymphoma. III. Determine the natural history of unresected or partially resected low grade gastric lymphoma treated medically.

OUTLINE: This is a randomized study. Patients are randomized to receive chlorambucil or placebo. Patients receive omeprazole daily for 1 week. Clarithromycin and tinidazole are administered twice daily for 1 week for the eradication of H. pylori infection. Patients are assessed every 2-3 months by endoscopy. Patients may receive a maximum of 3 courses of treatment every 2-3 months. Other regimens may be used if full eradication of H. pylori is not achieved. Patients who achieve complete response (eradication of H. pylori) are randomized to receive oral chlorambucil or placebo daily for 14 days. Treatment is repeated every 28 days for 6 courses. Patients are followed every 6 months for 2 years, then yearly thereafter.

PROJECTED ACCRUAL: A total of 200 patients will be accrued for this study.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 200
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gastric Cancer
• Stomach Neoplasms

Intervention

Drug:
• chlorambucil

• clarithromycin

• omeprazole

• tinidazole

Locations

Country	Name	City	State
Hong Kong	Queen Mary Hospital	Hong Kong
Poland	Oncology Centre Institute	Warsaw
South Africa	Frere Hospital	Central Region
Switzerland	Ospedale San Giovanni	Bellinzona
United Kingdom	Stoke Mandeville Hospital	Aylesbury-Buckinghamshire	England
United Kingdom	Bradford Hospitals NHS Trust	Bradford	England
United Kingdom	Kent and Canterbury Hospital	Canterbury	England
United Kingdom	Essex County Hospital	Colchester	England
United Kingdom	Walsgrave Hospital	Coventry	England
United Kingdom	Royal Free Hospital	Hampstead, London	England
United Kingdom	Ipswich Hospital NHS Trust	Ipswich	England
United Kingdom	Kettering General Hosptial	Kettering, Northants
United Kingdom	Leeds Teaching Hospital Trust	Leeds	England
United Kingdom	Charing Cross Hospital	London	England
United Kingdom	Middlesex Hospital- Meyerstein Institute	London	England
United Kingdom	Clatterbridge Centre for Oncology NHS Trust	Merseyside	England
United Kingdom	Milton Keynes General Hospital	Milton Keynes	England
United Kingdom	James Paget Hospital	Norfolk
United Kingdom	Mount Vernon Hospital	Northwood	England
United Kingdom	Nottingham City Hospital NHS Trust	Nottingham	England
United Kingdom	Peterborough Hospitals Trust	Peterborough	England
United Kingdom	Rotherham District General Hospital-NHS Trust	Rotherham
United Kingdom	Salford Royal Hospitals NHS Trust	Salford	England
United Kingdom	Salisbury District Hospital	Salisbury
United Kingdom	Weston Park Hospital	Sheffield	England
United Kingdom	Staffordshire General Hospital	Stafford
United Kingdom	Royal Marsden Hospital	Sutton	England
United Kingdom	Good Hope Hospital Trust	West Midlands	England
United Kingdom	Southend NHS Trust Hospital	Westcliff-On-Sea	England
United Kingdom	York District Hospital	York	England

Sponsors (1)

Lead Sponsor	Collaborator
Lymphoma Trials Office

Countries where clinical trial is conducted

Hong Kong,  Poland,  South Africa,  Switzerland,  United Kingdom, 

References & Publications (3)

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 Ki — View Citation

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 — View Citation

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 Amer