Ovarian CancerPhase 3CARACONCT01218490
Pelvic and Aortic-cava Lymphadenectomy Randomized for Ovarian Cancer
A Phase 3 study testing ovarian cancer surgery in people with Ovarian Cancer, run by Institut Cancerologie de l'Ouest at 19 sites in France.
Trial summary
It is a multicenter randomized trial of superior cleaning compared the absence of dissection in stage III patients with optimal surgical resection without retroperitoneal lymph node palpable. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian Cancer
- What is being tested?
- ovarian cancer surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 450 participants
- Where
- 19 sitesFrance
- Study dates
- 9 Dec 2008to May 2026
- Phase
- Phase 3
- 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
- Age> 18 years
- Karnofsky> 80, or ASA I-II
- Primary ovarian adenocarcinoma, or primitive peritoneal
- No retroperitoneal lymph node> 2cm (CT; MRI)
- Complete surgical staging
- Stage III-IV FIGO classification
- Indication of systemic chemotherapy before surgery or post surgery
Who cannot join
- Non Invasive Cancer
- non-epithelial or borderline cancer
- Pregnancy
- Previous pelvic lymphadenectomy or aortic-cava for a disease other than ovarian cancer
- Contraindication to Platinum and Paclitaxel
- Borderline Ovarian Tumor
- tumor recurrence
- Incomplete surgery, resectable lesion, Surgery sub optimal (R> 1cm)
Trial locations and contacts
19 sites in 1 country.
19 sites in 1 country
France19 sites
Clinique Sainte Thérèse
Amiens, 80000
Centre Paul Papin
Angers, 49000
Hospital
Angers, 49000
Hospital
Brest, 29609
Centre Jean Perrin
Clermont-Ferrand, 63011
Centre G F Leclerc
Dijon, 21079
Hospital
Lyon, 69437
Institut Paoli Calmette
Marseille, 13009
Centre Val d'Aurelle
Montpellier, 34298
Hôpital Européen Georges Pompidou
Paris, 75000
Hôpital Lariboisière
Paris, 75010
Hôpital des Diaconesses
Paris, 75020
Clinique Mutualiste
Rennes, 35000
Hopital
Rennes, 35000
Centre René Huguenin
Saint-Cloud, 92210
Institut Cancerologie de l'Ouest
Saint-Herblain, 44805
Centre Paul Strauss
Strasbourg, 67065
Institut Claudius Regaud
Toulouse, 31052
Hôpital Bretonneau
Tours, 37044
About this study
Official title: Pelvic and Aortic-cava Lymphadenectomy Randomized Phase III for Advanced Ovarian Cancer
It is a multicenter randomized trial of superior cleaning compared the absence of dissection in stage III patients with optimal surgical resection without retroperitoneal lymph node palpable.
- Conditions
- Ovarian Cancer
- Being tested
- ovarian cancer surgery
- Keywords
- surgery, ovarian cancer, lymphadectomy
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ovarian cancer surgeryProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| lymphadenectomy | Experimental | after surgery of the ovarian cancer, patient will have Pelvis and aortic-cava lymphadenectomy Receives: Procedure: ovarian cancer surgery |
| no lymphadectomy | No intervention | after surgery, the patient will not have pelvic and aortic-cave lymphadenectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
survival with out recurrence
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2010 (estimated)
- Study start9 Dec 2008
- Primary completionMay 2026 (estimated)
- Study completionMay 2026 (estimated)
Why it stopped: qualitative analysis of the study database
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian CancerStudies 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 3
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut Cancerologie de l'Ouest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01218490
- Sponsor's protocol ID
- SC 07/12-H
- Acronym
- CARACO
- Status last verified
- May 2019
- First submitted
- 8 Oct 2010
- Last updated
- 16 May 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pelvic and Aortic-cava Lymphadenectomy Randomized Phase III for Advanced Ovarian Cancer
- ClinicalTrials.gov ID
- NCT01218490
- Acronym / sponsor ID
- CARACO / SC 07/12-H
- Conditions
- Ovarian Cancer
- Keywords
- surgery, ovarian cancer, lymphadectomy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: qualitative analysis of the study database
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- Institut Cancerologie de l'OuestUniversity, hospital or other
- Study start
- 9 Dec 2008 (actual)
- Primary completion
- May 2026 (estimated)
- Study completion
- May 2026 (estimated)
- First posted
- 11 Oct 2010 (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.
It is a multicenter randomized trial of superior cleaning compared the absence of dissection in stage III patients with optimal surgical resection without retroperitoneal lymph node palpable.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| lymphadenectomy | Experimental | Procedure: ovarian cancer surgeryafter surgery of the ovarian cancer, patient will have Pelvis and aortic-cava lymphadenectomy |
| no lymphadectomy | No intervention | –after surgery, the patient will not have pelvic and aortic-cave lymphadenectomy |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age> 18 years
- Karnofsky> 80, or ASA I-II
- Primary ovarian adenocarcinoma, or primitive peritoneal
- No retroperitoneal lymph node> 2cm (CT; MRI)
- Complete surgical staging
Key exclusion criteria (8 listed)
- Non Invasive Cancer
- non-epithelial or borderline cancer
- Pregnancy
- Previous pelvic lymphadenectomy or aortic-cava for a disease other than ovarian cancer
- Contraindication to Platinum and Paclitaxel
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 |
|---|---|---|
| ovarian cancer surgery | Procedure or surgery | lymphadenectomy |
Primary outcome
survival with out recurrence
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2019.
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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.
The record lists no contact. Use the official record to reach the sponsor.
19 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing ovarian cancer surgery in people with Ovarian Cancer, run by Institut Cancerologie de l'Ouest at 19 sites in France.
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 7 inclusion and 8 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: paused, as of the sponsor's last update on 16 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in France. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
survival with out recurrence (time frame: 5 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 16 May 2019.