ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
1-800-718-1021
- age = 18 years old
- patients carrying a adenocarcinoma of the stomach or cardia histologically proven
- locally advanced tumour which may not be treated surgically or metastatic tumour
- the patients having a stenosante tumour responsible for a disphagy had to have a tumoral ablation or a prosthesis or a probe of food,
- measurable lesions according to criteria RECIST (specify measurement by spiral scanner of largest diameter of with less the one lesion of size higher than 1 cm) or appraisable but nonmeasurable (lesions < 1 cm, ascite, pleural effusion...)
- general state WHO < 2
- absence of insufficiency cardiac or coronary symptomatic
- absence of previous chemotherapy other that auxiliary stopped since more than 6 months
- filled questionnaires QLQ C30 and STO-22
- PNN = 1500/mm3, haemoglobin ≥ 10g/dl, plates= 100 000/mm3
- creatinin ≤ 110 micromol/l
- bilirubin ≤ 35 micromol/l
- disphagy or intestinal obstruction incompatible with a treatment per os or by a probe
of food
- pregnant or nursing woman
- previous of cardiac toxicity to the 5FU or to the anthracyclines
- radiotherapy less than 3 weeks before inclusion, whatever the site
- other evolutionary cancer threatening the short-term life
- metastasis cerebral or méningée known (without obligation to seek it)
- impossibility of regular follow-up for psychological, social, family or geographical
reasons
NEED INFO?
Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative
TRY A NEW SEARCH
Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.
Based on your search, you may also be interested in
- Toulouse,
Descriptive Information | ||||
---|---|---|---|---|
Brief Title ICMJE | Metastatic Gastric Cancer FFCD 03-07 | |||
Official Title ICMJE | Strategy Phase III Intergroup Study for Chemotherapy of the Metastatic or Locally Advanced Cancers of the Stomach | |||
Brief Summary | The purpose of this study is to compare the effectiveness of 2 different sequences of polychemotherapy among carrying patients of a adenocarcinoma of the stomach or cardia locally advanced or metastatic. | |||
Detailed Description | To compare the effectiveness of two different sequences of polychemotherapy among carrying patients of a adenocarcinoma of the stomach or cardia locally advanced or metastatic. | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 3 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment | |||
Condition ICMJE |
| |||
Intervention ICMJE |
| |||
Study Arms ICMJE |
| |||
Publications * | Guimbaud R, Louvet C, Ries P, Ychou M, Maillard E, André T, Gornet JM, Aparicio T, Nguyen S, Azzedine A, Etienne PL, Boucher E, Rebischung C, Hammel P, Rougier P, Bedenne L, Bouché O. Prospective, randomized, multicenter, phase III study of fluorouracil, leucovorin, and irinotecan versus epirubicin, cisplatin, and capecitabine in advanced gastric adenocarcinoma: a French intergroup (Fédération Francophone de Cancérologie Digestive, Fédération Nationale des Centres de Lutte Contre le Cancer, and Groupe Coopérateur Multidisciplinaire en Oncologie) study. J Clin Oncol. 2014 Nov 1;32(31):3520-6. doi: 10.1200/JCO.2013.54.1011. Epub 2014 Oct 6. Erratum in: J Clin Oncol. 2015 Apr 20;33(12):1416. | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Estimated Enrollment ICMJE | 416 | |||
Original Enrollment ICMJE | Same as current | |||
Actual Study Completion Date ICMJE | December 2009 | |||
Actual Primary Completion Date | December 2009 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| |||
Sex/Gender ICMJE |
| |||
Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | France | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00374036 | |||
Other Study ID Numbers ICMJE | 0305603 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | University Hospital, Toulouse | |||
Study Sponsor ICMJE | University Hospital, Toulouse | |||
Collaborators ICMJE |
| |||
Investigators ICMJE |
| |||
PRS Account | University Hospital, Toulouse | |||
Verification Date | October 2011 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |