Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
RMH E/C 1040
Study information
Scientific title
Acronym
Study hypothesis
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.
Ethics approval
Added 16/04/2009: The study was approved by the Local Research and Ethics Committee at each of the five participating centres.
Study design
Multicentre randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Advanced oesophago-gastric cancer
Intervention
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
Intervention type
Drug
Phase
Phase III
Drug names
5-fluorouracil (5FU), mitomycin-C
Primary outcome measures
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
Secondary outcome measures
No secondary outcome measures
Overall trial start date
01/07/1994
Overall trial end date
31/03/2001
Reason abandoned
Eligibility
Participant inclusion criteria
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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
254
Participant exclusion criteria
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
Recruitment start date
01/07/1994
Recruitment end date
31/03/2001
Locations
Countries of recruitment
United Kingdom
Trial participating centre
GI and Lymphoma Units
Sutton
SM2 5PT
United Kingdom
Funders
Funder type
Hospital/treatment centre
Funder name
The Royal Marsden NHS Foundation Trust (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2002 results in http://www.ncbi.nlm.nih.gov/pubmed/12377644
Publication citations
-
Results
Tebbutt NC, Norman A, Cunningham D, Iveson T, Seymour M, Hickish T, Harper P, Maisey N, Mochlinski K, Prior Y, Hill M, A multicentre, randomised phase III trial comparing protracted venous infusion (PVI) 5-fluorouracil (5-FU) with PVI 5-FU plus mitomycin C in patients with inoperable oesophago-gastric cancer., Ann. Oncol., 2002, 13, 10, 1568-1575.