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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00002615 |
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Date of registration:
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01/11/1999 |
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Primary sponsor: |
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Public title:
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Surgery With or Without Combination Chemotherapy in Treating Patients With Stomach Cancer
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Scientific title:
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A RANDOMISED, CONTROLLED TRIAL OF PRE- AND POST-OPERATIVE CHEMOTHERAPY IN PATIENTS WITH OPERABLE GASTRIC CANCER |
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Date of first enrolment:
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June 1994 |
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Target sample size:
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500 |
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Recruitment status: |
Active, not recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT00002615 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Primary Purpose: Treatment
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Countries of recruitment
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United Kingdom
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Contacts
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Name:
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William H. Allum, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Royal Marsden NHS Foundation Trust |
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Key inclusion & exclusion criteria
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DISEASE CHARACTERISTICS:
- Histologically proven resectable stage II or III adenocarcinoma of the stomach
- No evidence of locally inoperable or distant metastases on chest x-ray and any
combination of abdominal ultrasound, CT scan, or laparoscopy
PATIENT CHARACTERISTICS:
Age:
- Any age
Performance status:
- WHO 0-1
Hematopoietic:
- Not specified
Hepatic:
- Not specified
Renal:
- Creatinine clearance greater than 60 mL/min
Cardiovascular:
- No clinical evidence of uncontrolled angina pectoris, cardiac failure, or significant
uncontrolled cardiac arrhythmia
Other:
- No medical contraindication to study therapy
- No other prior malignancy except nonmelanomatous skin cancer or carcinoma in situ of
the cervix
- Not pregnant
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- No prior chemotherapy
Endocrine therapy:
- Not specified
Radiotherapy:
- No prior radiotherapy
Surgery:
- See Disease Characteristics
Age minimum:
N/A
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Gastric Cancer
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Intervention(s)
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Drug: cisplatin
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Drug: epirubicin hydrochloride
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Drug: fluorouracil
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Procedure: conventional surgery
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Secondary ID(s)
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CDR0000063914
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EU-94035
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MRC-ST02
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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