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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:	7 October 2014
Main ID:	EUCTR2007-005289-11-BE
Date of registration:	08/08/2008
Prospective Registration:	Yes
Primary sponsor:	Institut Jules Bordet
Public title:	A non randomized , stratified phase II trial evaluating efficacy and safety of oxaliplatin in combination with 5-Fluorouracil in patients with platinum-sensitive and platinum-resistant recurrent ovarian carcinoma
Scientific title:	A non randomized , stratified phase II trial evaluating efficacy and safety of oxaliplatin in combination with 5-Fluorouracil in patients with platinum-sensitive and platinum-resistant recurrent ovarian carcinoma
Date of first enrolment:	08/10/2008
Target sample size:	90
Recruitment status:	Authorised-recruitment may be ongoing or finished
URL:	https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2007-005289-11
Study type:	Interventional clinical trial of medicinal product
Study design:	Controlled: no Randomised: Open: Single blind: Double blind: Parallel group: Cross over: Other: If controlled, specify comparator, Other Medicinial Product: Placebo: Other:
Phase:

Countries of recruitment
Belgium

Contacts

Name:
Address:
Telephone:
Email:
Affiliation:

Name:
Address:
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Key inclusion & exclusion criteria

Inclusion criteria:
Ovarian cancer
recurrent disease
first and later platinum-sensitive relapse
second and later platinum-sensitive relapse
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:
previous whole abdominal radiotherapy
pregnancy
unstable angina or myocardial infarction in the last six months
severe hypersensitivity to platin compounds

Age minimum:
Age maximum:
Gender:
Female: yes
Male: no

Health Condition(s) or Problem(s) studied

ovarian carcinoma in relapse

Intervention(s)

Trade Name: Eloxatin
Product Name: Eloxatin
Product Code: L01XAO3
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: Eloxatin
Current Sponsor code: oxaliplatin 1
Other descriptive name: oxaliplatin

Primary Outcome(s)

Main Objective: to assess objective response rate

Secondary Objective: to assess time to progression, overall survival

Primary end point(s): objective response rate

Secondary Outcome(s)

Secondary ID(s)

oxaliplatine 1

Source(s) of Monetary Support

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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