- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01905163
Feasibility of Interval Debulking Surgery by Laparoscopy for Peritoneal Carcinosis in Chemosensitive Patients (CILOVE)
July 18, 2017 updated by: Centre Jean Perrin
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.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
47
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Angers, France, 49100
- Institut de Cancérologie de l'Ouest, site Paul Papin
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Clermont-Ferrand, France, 63011
- Centre Jean Perrin
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Clermont-Ferrand, France, 63003
- Chu Estaing
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Marseille, France, 13009
- Institut Paoli Calmettes
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Paris, France, 75015
- Hopital Europeen Georges-Pompidou
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Paris, France, 75005
- Institut Curie
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Saint Cloud, France, 92210
- Institut Curie - Hopital Rene Huguenin
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St Herblain, France, 44805
- Institut de Cancérologie de l'ouest
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Strasbourg, France, 67000
- Hopital de Hautepierre
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Toulouse, France, 31052
- Institut Claudius Regaud
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- 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.
- 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.
Exclusion Criteria:
- 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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: laparoscopic management
Tumor Debulking Surgery by laparoscopy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
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surgery
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Port site metastases
Time Frame: during 1 year post surgery
|
during 1 year post surgery
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Morbidity: intraoperative and postoperative complications
Time Frame: during surgery and 1 year post surgery
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during surgery and 1 year post surgery
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Pain
Time Frame: during the hospital stay (an expected average of 5 days), at 1 week, 1 month, 3 and 6 months post surgery
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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
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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
|
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.
|
1 year post-surgery
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Christophe POMEL, Pr, Centre Jean Perrin
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2013
Primary Completion (Actual)
August 1, 2016
Study Completion (Actual)
July 1, 2017
Study Registration Dates
First Submitted
July 9, 2013
First Submitted That Met QC Criteria
July 22, 2013
First Posted (Estimate)
July 23, 2013
Study Record Updates
Last Update Posted (Actual)
July 19, 2017
Last Update Submitted That Met QC Criteria
July 18, 2017
Last Verified
July 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2012-A01391-42
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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