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

Sponsor

Lymphoma Trials Office (Other)

Overall Status

Unknown status

CT.gov ID

NCT00003617

Collaborator

(none)

200

Enrollment

Locations

6.7

Patients Per Site

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Gastric Cancer	Drug: chlorambucil Drug: clarithromycin Drug: omeprazole Drug: tinidazole	Phase 3

Detailed 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.

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

200 participants

Allocation:

Randomized

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Mar 1, 1995

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

16 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

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