Contact information
Type
Scientific
Primary contact
Prof Marc Ychou
ORCID ID
Contact details
CRLC Val d'Aurelle
Parc Euromédecine
Montpellier
34298
France
MYchou@valdorel.fnclcc.fr
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
FFCD 9404 trial
Study information
Scientific title
Acronym
FFCD 9404
Study hypothesis
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
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
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
Phase
Phase II
Drug names
5-fluorouracil and cisplatin (FP) and leucovorin, bolus 5-fluorouracil and cisplatin (FLP)
Primary outcome measures
Safety
Secondary outcome measures
Clinical efficacy and quality of life
Overall trial start date
01/04/1995
Overall trial end date
01/05/1997
Reason abandoned
Eligibility
Participant 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.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
232
Participant exclusion criteria
Severe uncontrolled co-morbidities, brain metastases
Recruitment start date
01/04/1995
Recruitment end date
01/05/1997
Locations
Countries of recruitment
France
Trial participating centre
CRLC Val d'Aurelle
Montpellier
34298
France
Sponsor information
Organisation
French Federation of Digestive Cancers (Fédération Francophone de la Cancérologie Digestive [FFCD]) (France)
Sponsor details
7 bd Jeanne d'Arc
Dijon
21033
France
obouche@chu-reims.fr
Sponsor type
Other
Website
Funders
Funder type
Industry
Funder name
Lederle F93/LFOL/02
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
2006 results in http://www.ncbi.nlm.nih.gov/pubmed/17094417
Publication citations
-
Results
Duffour J, Bouché O, Rougier P, Milan C, Bedenne L, Seitz JF, Buecher B, Legoux JL, Ducreux M, Vetter D, Raoul JL, François E, Ychou M, Safety of cisplatin combined with continuous 5-FU versus bolus 5-FU and leucovorin, in metastatic gastrointestinal cancer (FFCD 9404 randomised trial)., Anticancer Res., 26, 5B, 3877-3883.