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.

Condition	Treatment or Intervention	Phase
stage I gastric cancer	Drug: chlorambucil  Drug: clarithromycin  Drug: omeprazole  Drug: tinidazole	Phase III

Further Study Details: 

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.

PROTOCOL 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.

Ages Eligible for Study:  16 Years and above

Criteria

PROTOCOL ENTRY CRITERIA:

--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

--Prior/Concurrent Therapy--

• Biologic therapy: Not specified
• Chemotherapy: Not specified
• Endocrine therapy: Not specified
• Radiotherapy: Not specified
• Surgery: See Disease Characteristics

--Patient Characteristics--

• Age: 16 and over
• Performance status: Not specified
• Life expectancy: Not specified
• Hematopoietic: Not specified
• Hepatic: Not specified
• Renal: Not specified

Hong Kong
      Queen Mary Hospital, Hong Kong,  Hong Kong
Poland
      Oncology Centre Institute, Warsaw,  02 781,  Poland
South Africa
      Frere Hospital, Central Region,  South Africa
Switzerland
      Ospedale San Giovanni, Bellinzona,  CH-6500,  Switzerland
United Kingdom
      James Paget Hospital, Norfolk,  NR31 6LA,  United Kingdom
      Kettering General Hosptial, Kettering, Northants,  NNI6 8UZ,  United Kingdom
      Rotherham District General Hospital-NHS Trust, Rotherham,  S60 2UD,  United Kingdom
      Salisbury District Hospital, Salisbury,  SP2 8BJ,  United Kingdom
      Staffordshire General Hospital, Stafford,  ST16 3SA,  United Kingdom
United Kingdom, England
      Bradford Hospitals NHS Trust, Bradford,  England,  BD9 6RJ,  United Kingdom
      Charing Cross Hospital, London,  England,  W6 8RF,  United Kingdom
      Clatterbridge Centre for Oncology NHS Trust, MERSEYSIDE,  England,  L63 4JY,  United Kingdom
      Essex County Hospital, Colchester,  England,  United Kingdom
      Good Hope Hospital Trust, West Midlands,  England,  B75 7RR,  United Kingdom
      Ipswich Hospital NHS Trust, Ipswich,  England,  IP4 5PD,  United Kingdom
      Kent and Canterbury Hospital, Canterbury,  England,  CT2 7NR,  United Kingdom
      Leeds Teaching Hospital Trust, Leeds,  England,  LS1 3EX,  United Kingdom
      Middlesex Hospital- Meyerstein Institute, London,  England,  WIT 3AA,  United Kingdom
      Milton Keynes General Hospital, Milton Keynes,  England,  MK6 5LD,  United Kingdom
      Mount Vernon Hospital, Northwood,  England,  HA6 2RN,  United Kingdom
      Nottingham City Hospital NHS Trust, Nottingham,  England,  NG5 1PB,  United Kingdom
      Peterborough Hospitals Trust, Peterborough,  England,  PE3 6DA,  United Kingdom
      Royal Free Hospital, Hampstead, London,  England,  NW3 2QG,  United Kingdom
      Royal Marsden Hospital, Sutton,  England,  SM2 5PT,  United Kingdom
      Salford Royal Hospitals NHS Trust, Salford,  England,  M6 8HD,  United Kingdom
      Southend NHS Trust Hospital, Westcliff-On-Sea,  England,  United Kingdom
      Stoke Mandeville Hospital, Aylesbury-Buckinghamshire,  England,  HP21 8AL,  United Kingdom
      Walsgrave Hospital, Coventry,  England,  CV2 2DX,  United Kingdom
      Weston Park Hospital, Sheffield,  England,  S1O 2SJ,  United Kingdom
      York District Hospital, York,  England,  Y031 8HE,  United Kingdom

Study chairs or principal investigators

B.W. Hancock,  Study Chair,  British National Lymphoma Investigation   

Study ID Numbers:  CDR0000066695; BNLI-LY03; EU-98040
Record last reviewed:  March 2004
Last Updated:  October 13, 2004
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00003617
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08