Ovarian CancerPhase 2CILOVENCT01905163
Feasibility of Interval Debulking Surgery by Laparoscopy for Peritoneal Carcinosis in Chemosensitive Patients
A Phase 2 study testing Tumor Debulking Surgery by laparoscopy in people with Ovarian Cancer and Fallopian Tube Cancer, run by Centre Jean Perrin at 10 sites in France.
Trial summary
This prospective nonrandomized multicenter phase II study, will evaluate the possibility of performing a laparoscopic interval debulking after a minimum of 3 cycles of chemotherapy in highly chemo-sensitive patients with advanced ovarian, tubal cancer or primary peritoneal. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian Cancer, Fallopian Tube Cancer, Peritoneal Cavity Cancer
- What is being tested?
- Tumor Debulking Surgery by laparoscopy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 10 sitesFrance
- Study dates
- Aug 2013to Jul 2017
- 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
- Age > or = 18 years
- performance status WHO < 2
- Epithelial ovarian, fallopian tubes or primary peritoneal carcinoma (histologically confirmed)
- Unresectable disease because of FIGO stage IV disease proven by imaging (CT Scan or PET CT) and/or diffuse extensive carcinosis considered unresectable for advanced FIGO stage IIIc; or patients unable to support a radical primary surgery because of age, comorbidities or altered general condition.
- No previous debulking surgery before neoadjuvant chemotherapy.
- Patients treated with a minimum of 3 cycles of platinum-based neoadjuvant chemotherapy.
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- Response to chemotherapy was radiologically confirmed (Scan-TAP) prior to interval surgery:
- No evidence of peritoneal supra-mesocolic carcinomatosis ; Residual pelvic masses smaller than 10 cm ; Absence of suspect supra-centimeter retroperitoneal lymphadenopathy
- able to read, write and understand French.
- Member of a Social Security scheme.
- written informed consent.
Who cannot join
- Patient unable to support laparoscopy
- psychiatric condition or social or geographic situation that would impede appropriate study participation
- Concomitant participation in another clinical trial evaluating surgical treatment (interfering with the evaluation of the main endpoint)
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
France10 sites
Institut de Cancerologie de l'Ouest, site Paul Papin
Angers, 49100
CHU Estaing
Clermont-Ferrand, 63003
Centre Jean Perrin
Clermont-Ferrand, 63011
Institut Paoli Calmettes
Marseille, 13009
Institut Curie
Paris, 75005
Hôpital Européen Georges-Pompidou
Paris, 75015
Institut Curie - Hôpital René Huguenin
Saint-Cloud, 92210
Institut de Cancérologie de L'Ouest
Saint-Herblain, 44805
Hôpital de Hautepierre
Strasbourg, 67000
Institut Claudius Regaud
Toulouse, 31052
About this study
Official title: Prospective Study Assessing the Feasibility of Interval Debulking Surgery by Laparoscopy for Peritoneal Carcinomatosis of Ovarian Origin, Tubal or Primary Peritoneal, in Chemosensitive Patients Treated by Neoadjuvant Chemotherapy.
This prospective nonrandomized multicenter phase II study, will evaluate the possibility of performing a laparoscopic interval debulking after a minimum of 3 cycles of chemotherapy in highly chemo-sensitive patients with advanced ovarian, tubal cancer or primary peritoneal.
- Being tested
- Tumor Debulking Surgery by laparoscopy
- Keywords
- Laparoscopy, interval debulking surgery
- Medical subject headings
- Ovarian Neoplasms, Fallopian Tube Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tumor Debulking Surgery by laparoscopyProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| laparoscopic management | Experimental | Tumor Debulking Surgery by laparoscopy Receives: Procedure: Tumor Debulking Surgery by laparoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
the rate of conversion to laparotomy
Feasibility of the surgical laparoscopic management of interval debulking surgery will be assessed by the rate of conversion to laparotomy.
Measured: surgery
Secondary outcomes (5)
Port site metastases
Measured: during 1 year post surgery
Morbidity: intraoperative and postoperative complications
Measured: during surgery and 1 year post surgery
Pain
Measured: during the hospital stay (an expected average of 5 days), at 1 week, 1 month, 3 and 6 months post surgery
Quality of life using EORTC QLQ-C30
Measured: before surgery (an expected average of 7 days before surgery), 1 week , 1 month, 3 and 6 months post-surgery
Economic evaluation
economic evaluation will be assess by a quantification of the additional costs of surgery, duration and cost of hospitalization, number of possible re-interventions or hospitalizations.
Measured: 1 year post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2013 (estimated)
- Study startAug 2013
- Primary completionAug 2016
- Study completionJul 2017
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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Jean Perrin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christophe POMEL, Pr, Principal investigator, Centre Jean Perrin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01905163
- Sponsor's protocol ID
- 2012-A01391-42
- Acronym
- CILOVE
- Status last verified
- Jul 2017
- First submitted
- 9 Jul 2013
- Last updated
- 19 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study Assessing the Feasibility of Interval Debulking Surgery by Laparoscopy for Peritoneal Carcinomatosis of Ovarian Origin, Tubal or Primary Peritoneal, in Chemosensitive Patients Treated by Neoadjuvant Chemotherapy.
- ClinicalTrials.gov ID
- NCT01905163
- Acronym / sponsor ID
- CILOVE / 2012-A01391-42
- Keywords
- Laparoscopy, interval debulking surgery
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Centre Jean PerrinUniversity, hospital or other
- Study start
- Aug 2013
- Primary completion
- Aug 2016 (actual)
- Study completion
- Jul 2017 (actual)
- First posted
- 23 Jul 2013 (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 prospective nonrandomized multicenter phase II study, will evaluate the possibility of performing a laparoscopic interval debulking after a minimum of 3 cycles of chemotherapy in highly chemo-sensitive patients with advanced ovarian, tubal cancer or primary peritoneal.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| laparoscopic management | Experimental | Procedure: Tumor Debulking Surgery by laparoscopyTumor Debulking Surgery by laparoscopy |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Age > or = 18 years
- performance status WHO < 2
- Epithelial ovarian, fallopian tubes or primary peritoneal carcinoma (histologically confirmed)
- Unresectable disease because of FIGO stage IV disease proven by imaging (CT Scan or PET CT) and/or diffuse extensive carcinosis considered unresectable for advanced FIGO stage IIIc; or patients unable to support a radical primary surgery because of age, comorbidities or altered general condition.
- No previous debulking surgery before neoadjuvant chemotherapy.
Key exclusion criteria (3 listed)
- Patient unable to support laparoscopy
- psychiatric condition or social or geographic situation that would impede appropriate study participation
- Concomitant participation in another clinical trial evaluating surgical treatment (interfering with the evaluation of the main endpoint)
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 |
|---|---|---|
| Tumor Debulking Surgery by laparoscopy | Procedure or surgery | laparoscopic management |
Primary outcome
the rate of conversion to laparotomy
Time frame: surgery
Feasibility of the surgical laparoscopic management of interval debulking surgery will be assessed by the rate of conversion to laparotomy.
5 secondary outcomes
Port site metastases
Time frame: during 1 year post surgery
Morbidity: intraoperative and postoperative complications
Time frame: during surgery and 1 year post surgery
Pain
Time frame: during the hospital stay (an expected average of 5 days), at 1 week, 1 month, 3 and 6 months post surgery
Quality of life using EORTC QLQ-C30
Time frame: before surgery (an expected average of 7 days before surgery), 1 week , 1 month, 3 and 6 months post-surgery
Economic evaluation
Time frame: 1 year post-surgery
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 19 Jul 2017.
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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.
Christophe POMEL, Pr principal investigator
Centre Jean Perrin
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tumor Debulking Surgery by laparoscopy in people with Ovarian Cancer and Fallopian Tube Cancer, run by Centre Jean Perrin at 10 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 11 inclusion and 3 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 19 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 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 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?
the rate of conversion to laparotomy (time frame: surgery). 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 19 Jul 2017.