Condition category
Cancer
Date applied
01/09/2005
Date assigned
06/09/2005
Last edited
24/09/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.ffcd.fr/

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

  1. 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.

Additional files

Editorial Notes