Ovarian CarcinomaPhase 2NCT01481701
A Trial Evaluating Efficacy and Safety of Oxaliplatin With 5-Fluorouracil in Patients With Recurrent Ovarian Carcinoma
A Phase 2 study testing Oxaliplatin in people with Ovarian Carcinoma and Relapse, run by Jules Bordet Institute at 1 site in Belgium.
Trial summary
This is a Phase II study for recurrent ovarian carcinoma platinum-sensitive and resistant tumors Folfox regimen. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian Carcinoma, Relapse
- What is being tested?
- Oxaliplatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteBelgium
- Study dates
- Oct 2008to May 2014
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ovarian carcinoma relapse
Who cannot join
- neurotoxicity grade III renal clearance < 60 ml/min
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
This is a Phase II study for recurrent ovarian carcinoma platinum-sensitive and resistant tumors Folfox regimen.
Read the detailed description
Evaluation of the safety and the efficacy of a combination of oxaliplatin and 5FU (Folfox) in patients with ovarian carcinoma relapsing either after platinum-combined regimen.
The Folfox regimen is administered every 14 days. Evaluation of the toxicity is performed at each cycle and evaluation of the efficacy every 4 cycles of chemotherapy.
- Conditions
- Ovarian Carcinoma, Relapse
- Being tested
- Oxaliplatin
- Keywords
- ovarian carcinoma, Bordet, relapse
- Medical subject headings
- Ovarian Neoplasms, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OxaliplatinDrug
Also called No other intervention
85 mg/m² / 14days
oxaliplatinDrug
oxaliplatin
| Study group | Role | What they receive |
|---|---|---|
| intravenous chemotherapy | Experimental | treatment of ovarian carcinoma in relapse Receives: Drug: Oxaliplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate
Measured: at 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2011 (estimated)
- Study startOct 2008
- Primary completionMay 2014
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jules Bordet Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Veronique D'Hondt, MD,PhD, Principal investigator, Jules Bordet Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01481701
- Sponsor's protocol ID
- Folfox
- Status last verified
- Sep 2013
- First submitted
- 18 Jul 2011
- Last updated
- 15 Oct 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT01481701
- Acronym / sponsor ID
- Folfox
- Conditions
- Ovarian Carcinoma, Relapse
- Keywords
- ovarian carcinoma, Bordet, relapse
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Jules Bordet InstituteUniversity, hospital or other
- Study start
- Oct 2008
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 29 Nov 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a Phase II study for recurrent ovarian carcinoma platinum-sensitive and resistant tumors Folfox regimen.
Detailed description
Evaluation of the safety and the efficacy of a combination of oxaliplatin and 5FU (Folfox) in patients with ovarian carcinoma relapsing either after platinum-combined regimen.
The Folfox regimen is administered every 14 days. Evaluation of the toxicity is performed at each cycle and evaluation of the efficacy every 4 cycles of chemotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| intravenous chemotherapy | Experimental | Drug: Oxaliplatintreatment of ovarian carcinoma in relapse |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- ovarian carcinoma relapse
Key exclusion criteria (1 listed)
- neurotoxicity grade III renal clearance < 60 ml/min
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OxaliplatinAlso: No other intervention85 mg/m² / 14days | Drug | intravenous chemotherapy |
| oxaliplatinoxaliplatin | Drug | intravenous chemotherapy |
Primary outcome
Objective response rate
Time frame: at 4 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Veronique D'Hondt, MD,PhD principal investigator
Jules Bordet Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Oxaliplatin in people with Ovarian Carcinoma and Relapse, run by Jules Bordet Institute at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate (time frame: at 4 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2014.