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Antibiotic Therapy in Treating Patients With Low Grade Gastric Lymphoma

This study has been completed.
Sponsor:
Collaborator:
University of Glasgow
Information provided by (Responsible Party):
European Organisation for Research and Treatment of Cancer - EORTC
ClinicalTrials.gov Identifier:
NCT00003151
First received: November 1, 1999
Last updated: June 29, 2012
Last verified: June 2012
  Purpose

RATIONALE: Antibiotics may stop the growth of Helicobacter pylori which may be associated with gastric lymphoma.

PURPOSE: Phase II trial to study the effectiveness of antibiotic therapy in treating patients with low grade gastric lymphoma that has not been previously treated.


Condition Intervention Phase
Lymphoma
Dietary Supplement: bismuth subcitrate
Drug: amoxicillin
Drug: clarithromycin
Drug: metronidazole hydrochloride
Drug: omeprazole
Drug: tetracycline hydrochloride
Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: A Phase II Clinical Trial of Anti-Helicobacter Pylori Treatment in Endoscopically Diagnosed Low-Grade Localized Gastric Lymphoma

Resource links provided by NLM:


Further study details as provided by European Organisation for Research and Treatment of Cancer - EORTC:

Estimated Enrollment: 96
Study Start Date: September 1997
Primary Completion Date: October 1998 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES: I. Determine the rate of eradication of Helicobacter pylori using omeprazole, colloidal bismuth subcitrate, tetracycline, and metronidazole in patients with low grade gastric lymphoma. II. Determine the macroscopic/endoscopic and microscopic healing/remission rate after eradication of Helicobacter pylori in this patient population. III. Determine the natural history of low grade gastric lymphoma after eradication of Helicobacter pylori.

OUTLINE: This is a nonrandomized, open label, multicenter study. Patients receive oral omeprazole bid on days 1-10, oral bismuth subcitrate and oral tetracycline qid on days 4-10, and oral metronidazole tid on days 4-10. Patients are evaluated at 8 weeks. Patients who experience complete remission and are H. pylori negative proceed to follow up. Patients with complete remission or no change but who are H. pylori positive proceed to a second course of therapy with the previous schedule or with omeprazole bid, amoxicillin qid, and clarithromycin tid for 14 days. Patients who experience no change but are H. pylori negative are followed at 6 and 9 months and restaged. Patients are followed at 6, 9, 12, 18, and 24 months, then annually thereafter.

PROJECTED ACCRUAL: Approximately 60-96 patients will be accrued for this study.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS: Histologically proven, previously untreated, low grade gastric lymphoma Clinical stage I and II1 No bulky disease No high grade component (grade 5 and 4, if monoclonality proven, allowed) Documented presence/absence of H. pylori infection Measurable and/or evaluable disease

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: WHO 0-2 Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: Not pregnant or lactating Fertile patients must use effective contraception No prior or concurrent malignancies unless: At least 1 year remission Low risk or recurrence No prior gastric malignancy No nonmalignant disease causing poor medical risk No allergy to omeprazole

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Not specified Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy to the abdomen Surgery: No prior gastric surgery except simple closure of perforated ulcer with or without wedge excision of the ulcer Other: No prior therapy for gastric lymphoma At least 30 days since experimental therapy No other concurrent experimental therapy At least 30 days since antibiotics with activity against H. pylori

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00003151

Locations
United Kingdom
Royal United Hospital
Bath, England, United Kingdom, BA1 3NG
University Birmingham N.H.S. Trust
Birmingham, England, United Kingdom, B15 2TA
Royal Free Hospital
Hampstead, London, England, United Kingdom, NW3 2QG
St. James's Hospital
Leeds, England, United Kingdom, LS9 7TF
Royal Free Hospital School of Medicine
London, England, United Kingdom, NW3 2PF
Guy's, King's and St. Thomas' Hospitals Trust
London, England, United Kingdom, SE1 7EH
Hammersmith Hospital
London, England, United Kingdom, W12 ONN
Middlesex Hospital- Meyerstein Institute
London, England, United Kingdom, W1N 8AA
Charing Cross Hospital
London, England, United Kingdom, W6 8RF
Royal Marsden NHS Trust
London, England, United Kingdom, SW3 6JJ
Saint Bartholomew's Hospital
London, England, United Kingdom, EC1A 7BE
Clatterbridge Centre for Oncology NHS Trust
Merseyside, England, United Kingdom, L63 4JY
Newcastle General Hospital
Newcastle Upon Tyne, England, United Kingdom, NE4 6BE
Mount Vernon Hospital
Northwood, England, United Kingdom, HA6 2RN
Nottingham City Hospital NHS Trust
Nottingham, England, United Kingdom, NG5 1PB
Oxford Radcliffe Hospital
Oxford, England, United Kingdom, 0X3 7LJ
Royal South Hants Hospital
Southampton, England, United Kingdom, SO14 0YG
Royal Marsden Hospital
Sutton, England, United Kingdom, SM2 5PT
Aberdeen Royal Infirmary
Aberdeen, Scotland, United Kingdom, AB25 2ZN
Western General Hospital
Edinburgh, Scotland, United Kingdom, EH4 9NQ
Beatson Oncology Centre
Glasgow, Scotland, United Kingdom, G11 6NT
Royal Infirmary
Glasgow, Scotland, United Kingdom, G4 0SF
Sponsors and Collaborators
European Organisation for Research and Treatment of Cancer - EORTC
University of Glasgow
Investigators
Study Chair: Patrice P. Carde, MD Gustave Roussy, Cancer Campus, Grand Paris
Study Chair: John W. Sweetenham, MD University of Colorado, Denver
  More Information

Additional Information:
No publications provided

Responsible Party: European Organisation for Research and Treatment of Cancer - EORTC
ClinicalTrials.gov Identifier: NCT00003151     History of Changes
Other Study ID Numbers: EORTC-20961, EORTC-20961, CRC-EORTC-20961, HOVON-33
Study First Received: November 1, 1999
Last Updated: June 29, 2012
Health Authority: United States: Federal Government

Keywords provided by European Organisation for Research and Treatment of Cancer - EORTC:
contiguous stage II marginal zone lymphoma
contiguous stage II small lymphocytic lymphoma
stage I marginal zone lymphoma
stage I small lymphocytic lymphoma
extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue

Additional relevant MeSH terms:
Lymphoma
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
Bismuth tripotassium dicitrate
Clarithromycin
Metronidazole
Tetracycline
Antacids
Anti-Bacterial Agents
Anti-Infective Agents
Anti-Ulcer Agents
Antiparasitic Agents
Antiprotozoal Agents
Enzyme Inhibitors
Gastrointestinal Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protein Synthesis Inhibitors
Radiation-Sensitizing Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014