|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
EUCTR |
|
Last refreshed on:
|
23 January 2017 |
|
Main ID: |
EUCTR2008-000551-10-BE |
|
Date of registration:
|
12/03/2008 |
|
Prospective Registration:
|
Yes |
|
Primary sponsor: |
|
|
Public title:
|
Randomised Phase II study of biweekly versus fractionated triweekly combination Taxotere-Cisplatin-5FU in advanced gastric and gastro-esophageal junction cancer - DoGE01
|
|
Scientific title:
|
Randomised Phase II study of biweekly versus fractionated triweekly combination Taxotere-Cisplatin-5FU in advanced gastric and gastro-esophageal junction cancer - DoGE01 |
|
Date of first enrolment:
|
19/03/2009 |
|
Target sample size:
|
134 |
|
Recruitment status: |
Not Recruiting |
|
URL:
|
https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2008-000551-10 |
|
Study type:
|
Interventional clinical trial of medicinal product |
|
Study design:
|
Controlled: yes
Randomised: yes
Open: yes
Single blind: no
Double blind: no
Parallel group: no
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: no
Placebo: no
Other: no
Other specify the comparator: other schedule
|
|
Phase:
|
Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): yes
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): no
|
|
|
Countries of recruitment
|
|
Belgium
| | | | | | | |
|
Contacts
|
|
Name:
|
|
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
|
|
|
Name:
|
|
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
|
| |
|
Key inclusion & exclusion criteria
|
Inclusion criteria:
*Histologically proven chemotherapy-naïve advanced adenocarcinoma of the stomach, esogastric junction, or esophagus.
*Patients with locally advanced inoperable tumors rendered operable by chemotherapy, could be operated on.
*evaluable lesions
*A previous adjuvant chemotherapy for gastric cancer is authorized if the tumor has not progressed during or 6 months after chemotherapy administration, provided it contains no cisplatin.
*Age = 18 years
*Performance status < 2
*Hematological examination : Neutrophilic count = 1.5 X 106 / l, Platelets = 100 X 106 / l , Hemoglobin = 11 g / dl
*ASAT/ALAT = 1,5 X ULN , Alkaline Phosphatases < 2,5 ULN
*Bilirubin = 1 X ULN
*Written informed consent
*Clearance creatinine = 60 ml/min (calculated or evaluated by isotopic method)
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Exclusion criteria:
*Unwillingness to take anticonceptional means for women in procreating age
*Ongoing pregnancy or lactation.
*Uncontrolled Central nervous system metastasis.
*History of another concomitant malignant disease with the exception of in situ cervix carcinoma or non-melanoma skin cancer
*Participation to another clinical study within 4 weeks before inclusion in this study
*Concomitant antineoplasic treatment.
*Previous use in adjuvant setting of more than 400 mg/m² (total cumulated dose) cisplatin
*Known deficiency in DPD or allergy to one or more drugs of the study
*History of other uncontrolled life-threatening or severe disease
*Uncontrolled infectious disease.
*Impossibility to assure an adequate follow-up due to psychological, familial, social and/or geographic reasons.
*Liver tests: Bilirubin > 1 x upper limit of normal (ULN), SASAT and/or SALAT >1.5 x ULN concomitant with alkaline Phosphatases > 2.5 x ULN.
*Clearance creatinine < 60 ml/min
*Uncontrolled angina pectoris or myocardial infarction < 6 weeks before beginning of the chemotherapy
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
|
|
Health Condition(s) or Problem(s) studied
|
Advanced gastric and oesogastric junction adenocarcinoma
MedDRA version: 9.1
Level: SOC
Classification code 10017947
Term: Gastrointestinal disorders
MedDRA version: 9.1
Level: SOC
Classification code 10029104
Term: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
|
|
Intervention(s)
|
Trade Name: TAXOTERE
Product Name: Taxotere 80mg/2ml
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: cisplatin
CAS Number: 15663271
Other descriptive name: Platosin
Concentration unit: mg/m2 milligram(s)/square meter
Concentration type: equal
Concentration number: 100-
INN or Proposed INN: FLUOROURACIL
CAS Number: 51218
Other descriptive name: Fluracedyl
Concentration unit: mg/m2 milligram(s)/square meter
Concentration type: equal
Concentration number: 1000-
|
|
Primary Outcome(s)
|
|
Main Objective: evaluate toxicity of a biweekly and a fractionated triweekly regimen of Taxotere-Cisplatin-5FU in advanced gastric and oesogastric junction cancer
|
|
Primary end point(s): evaluate toxicity of a biweekly and a fractionated triweekly regimen of Taxotere-Cisplatin-5FU in advanced gastric and oesogastric junction cancer
|
Secondary Objective: a) Evaluation of the efficacy in both regimen based on an outpatient administration.
b) Evaluation of survival
c) Evaluation of progression free survival
d) Translational research
|
|
Source(s) of Monetary Support
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|