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



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

For Condition: stage 1 gastric cancer
Status: No longer recruiting
Sponsor(s): British National Lymphoma Investigation ,
Synopsis: 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.
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.
Eligibility:
Study Type:
  Interventional, Treatment
Minimum Age/Maximum Age: 16 Years/
Genders: 
Protocol Entry 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
Total Enrollment: 

Location and Contact Information:

Overall Study Official:
B.W.Hancock,  Study Chair,  British National Lymphoma Investigation

Charing Cross Hospital
London,  England,  W6 8RF
United Kingdom
 

James Paget Hospital
Norfolk,  ,  NR31 6LA
United Kingdom
 

Peterborough Hospitals Trust
Peterborough,  England,  PE3 6DA
United Kingdom
 

Ospedale San Giovanni
Bellinzona,  ,  CH-6500
Switzerland
 

Stoke Mandeville Hospital
Aylesbury-Buckinghamshire,  England,  HP21 8AL
United Kingdom
 

Frere Hospital
Central Region,  , 
South Africa
 

Ipswich Hospital NHS Trust
Ipswich,  England,  IP4 5PD
United Kingdom
 

Nottingham City Hospital NHS Trust
Nottingham,  England,  NG5 1PB
United Kingdom
 

Milton Keynes General Hospital
Milton Keynes,  England,  MK6 5LD
United Kingdom
 

Bradford Hospitals NHS Trust
Bradford,  England,  BD9 6RJ
United Kingdom
 

Queen Mary Hospital
Hong Kong,  , 
Hong Kong
 

Good Hope Hospital Trust
West Midlands,  England,  B75 7RR
United Kingdom
 

Middlesex Hospital- Meyerstein Institute
London,  England,  WIT 3AA
United Kingdom
 

Royal Free Hospital
Hampstead, London,  England,  NW3 2QG
United Kingdom
 

Mount Vernon Hospital
Northwood,  England,  HA6 2RN
United Kingdom
 

Clatterbridge Centre for Oncology NHS Trust
Merseyside,  England,  L63 4JY
United Kingdom
 

Salford Royal Hospitals NHS Trust
Salford,  England,  M6 8HD
United Kingdom
 

Weston Park Hospital
Sheffield,  England,  S1O 2SJ
United Kingdom
 

Salisbury District Hospital
Salisbury,  ,  SP2 8BJ
United Kingdom
 

Royal Marsden Hospital
Sutton,  England,  SM2 5PT
United Kingdom
 

Leeds Teaching Hospital Trust
Leeds,  England,  LS1 3EX
United Kingdom
 

Walsgrave Hospital
Coventry,  England,  CV2 2DX
United Kingdom
 

Oncology Centre Institute
Warsaw,  ,  02 781
Poland
 

Kettering General Hosptial
Kettering, Northants,  ,  NNI6 8UZ
United Kingdom
 

Rotherham District General Hospital-NHS Trust
Rotherham,  ,  S60 2UD
United Kingdom
 

Essex County Hospital
Colchester,  England, 
United Kingdom
 

Staffordshire General Hospital
Stafford,  ,  ST16 3SA
United Kingdom
 

Kent and Canterbury Hospital
Canterbury,  England,  CT2 7NR
United Kingdom
 

York District Hospital
York,  England,  Y031 8HE
United Kingdom
 

Southend NHS Trust Hospital
Westcliff-On-Sea,  England, 
United Kingdom
 


Additional Information:
Study ID Numbers:
  CDR0000066695;  BNLI-LY03,EU-98040
Study Start Date: March 1995
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003617

Other Stage 1 Gastric Cancer Studies:
1. Combination Chemotherapy Followed by Surgery in Treating Patients With Stomach Cancer

2. Chemotherapy and Radiation Therapy in Treating Patients With Stomach Cancer

3. Surgery With or Without Combination Chemotherapy in Treating Patients With Cancer of the Esophagus

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

5. Oxaliplatin and Fluorouracil Plus Radiation Therapy in Treating Patients With Primary Esophageal or Stomach Cancer

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

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