Phase II randomized trial comparing 5-fluorouracil in continuous infusion and cisplatin (FP) versus leucovorin, bolus 5-fluorouracil and cisplatin (FLP) in metastatic gastric, pancreatic and oesophageal cancer

ISRCTN	ISRCTN05842222
DOI	https://doi.org/10.1186/ISRCTN05842222
Secondary identifying numbers	FFCD 9404 trial

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Prof Marc Ychou
Scientific

CRLC Val d'Aurelle
Parc Euromédecine
Montpellier
34298
France

Email	MYchou@valdorel.fnclcc.fr

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Treatment
Scientific title
Study acronym	FFCD 9404
Study objectives	Compare the safety (primary objective) and clinical efficacy and quality of life (secondary objectives) of FLP versus FP as a first line chemotherapy in patients with metastatic gastric, pancreatic and oesophageal cancer
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Metastatic gastric, pancreatic and oesophageal cancer
Intervention	First line chemotherapy - 5-fluorouracil in continuous infusion and cisplatin (FP) versus leucovorin, bolus 5-fluorouracil and cisplatin (FLP)
Intervention type	Drug
Pharmaceutical study type(s)
Phase	Phase II
Drug / device / biological / vaccine name(s)	5-fluorouracil and cisplatin (FP) and leucovorin, bolus 5-fluorouracil and cisplatin (FLP)
Primary outcome measure	Safety
Secondary outcome measures	Clinical efficacy and quality of life
Overall study start date	01/04/1995
Completion date	01/05/1997

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	232
Key inclusion criteria	Histologically proven carcinoma of the oesophagus, the stomach or the pancreas, with a measurable metastatic disease (≤15 mm) and without indication of radiotherapy and/or surgery; no prior chemotherapy for metastatic disease and, in case of adjuvant chemotherapy, no regimen containing cisplatin; age ≤75 years and World Health Organization (WHO) performance status <2; adequate baseline organ function, defined as neutrophile count ≥1500/mm^3, platelet count ≥100,000/mm^3 and creatinine level <1.25 normal level; in case of patient older than 70 years and/or creatinine level between 1 and 1.25 normal limit, creatinine clearance had to be more than 60 ml/mm; and written informed consent approved by the local Ethical Committee was given by all the participants before they entered the study.
Key exclusion criteria	Severe uncontrolled co-morbidities, brain metastases
Date of first enrolment	01/04/1995
Date of final enrolment	01/05/1997

CRLC Val d'Aurelle

Montpellier
34298
France

French Federation of Digestive Cancers (Fédération Francophone de la Cancérologie Digestive [FFCD]) (France)
Other

7 bd Jeanne d'Arc
Dijon
21033
France

Industry

Lederle F93/LFOL/02

No information available

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/09/2006		Yes	No