A randomised study of continuous infusional 5-fluorouracil (5FU) with or without bolus mitomycin-C in patients with advanced oesophago-gastric cancer

ISRCTN	ISRCTN43866427
DOI	https://doi.org/10.1186/ISRCTN43866427
Protocol serial number	RMH E/C 1040
Sponsor	The Royal Marsden NHS Foundation Trust (UK)
Funder	The Royal Marsden NHS Foundation Trust (UK)

Submission date: 19/08/2002
Registration date: 19/08/2002
Last edited: 21/11/2012

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr D Cunningham
Scientific

GI and Lymphoma Units
Department of Medicine
Royal Marsden Hospital
Downs Road
Sutton
SM2 5PT
United Kingdom

Study information

Primary study design	Interventional
Study design	Multicentre randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title
Study objectives	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(s)	Added 16/04/2009: The study was approved by the Local Research and Ethics Committee at each of the five participating centres.
Health condition(s) or problem(s) studied	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 / device / biological / vaccine name(s)	5-fluorouracil (5FU), mitomycin-C
Primary outcome measure(s)	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
Key secondary outcome measure(s)	No secondary outcome measures
Completion date	31/03/2001

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	254
Key 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
Key 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
Date of first enrolment	01/07/1994
Date of final enrolment	31/03/2001

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

GI and Lymphoma Units

Sutton
SM2 5PT
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/10/2002		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes