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ISRCTN
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ISRCTN43866427
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ClinicalTrials.gov identifier
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Public title
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A randomised study of continuous infusional 5-fluorouracil (5FU) with or without bolus mitomycin-C in patients with advanced oesophago-gastric cancer
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Scientific title
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Acronym
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N/A
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Serial number at source
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RMH E/C 1040
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Study hypothesis
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Added 16/04/2009:
To compare protracted venous infusion (PVI) fluorouracil (5-FU) with PVI 5-FU plus mitomycin C (MMC) in patients with advanced oesophago-gastric cancer.
As of 05/08/09 this trial was updated. All updates can be found under the relevant field with the above update date.
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Ethics approval
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Added 16/04/2009: The study was approved by the Local Research and Ethics Committee at each of the five participating centres.
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Study design
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Multicentre randomised controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Advanced oesophago-gastric cancer
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Participants - inclusion criteria
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1. Histological evidence of metastatic carcinoma of the oesophagus or stomach
2. Histological evidence of locally advanced oesophageal or gastric carcinoma, not amenable to surgery or radiotherapy and for whom high dose chemotherapy or more intensive chemotherapy is not appropriate, normally around the age of 60
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Participants - exclusion criteria
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1. Intra-cerebral metastases
2. History of other malignancy (apart from adequately treated non-melanotic skin cancer or carcinoma in situ of the uterine cervix)
3. Uncontrolled angina pectoris or clinically significant cardiac dysrhythmias
4. Pregnancy
5. Any psychological condition precluding informed consent
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Anticipated start date
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01/07/1994
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Anticipated end date
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31/03/2001
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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254
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Interventions
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Two arms:
1. Protracted venous infusion (PVI) 5FU 300 mg/m^2/day over 24 weeks
2. PVI 5FU 300 mg/m^2/day over 24 weeks and mitomycin-C 7 mg/m^2 (total dose no more than 56 mg) four courses over 24 weeks
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Primary outcome measure(s)
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Added 16/04/2009:
1. Tumour response, assessed by computed tomography (CT) scan before chemotherapy, 6-weekly during chemotherapy and 3-monthly thereafter until death or disease progression
2. Survival
3. Toxicity, evaluated on a weekly basis and graded according to the National Cancer Institute Common Toxicity Criteria (NCI CTC)
4. Quality of life, assessed using European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 questionnaires before randomisation and every 12 weeks thereafter
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Secondary outcome measure(s)
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No secondary outcome measures
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Sources of funding
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The Royal Marsden NHS Foundation Trust (UK)
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Trial website
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Publications
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2002 results in http://www.ncbi.nlm.nih.gov/pubmed/12377644
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Contact name
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Dr
D
Cunningham
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Address
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GI and Lymphoma Units
Department of Medicine
Royal Marsden Hospital
Downs Road
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City/town
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Sutton
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Zip/Postcode
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SM2 5PT
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Country
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United Kingdom
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Sponsor
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The Royal Marsden NHS Foundation Trust (UK)
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Address
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Downs Road
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City/town
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Sutton
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Zip/Postcode
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SM2 5PT
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Country
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United Kingdom
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Date applied
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19/08/2002
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Last edited
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05/08/2009
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Date ISRCTN assigned
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19/08/2002
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