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

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

      • Angers, France, 49100
        • Institut de Cancérologie de l'Ouest, site Paul Papin
      • Clermont-Ferrand, France, 63011
        • Centre Jean Perrin
      • Clermont-Ferrand, France, 63003
        • Chu Estaing
      • Marseille, France, 13009
        • Institut Paoli Calmettes
      • Paris, France, 75015
        • Hopital Europeen Georges-Pompidou
      • Paris, France, 75005
        • Institut Curie
      • Saint Cloud, France, 92210
        • Institut Curie - Hopital Rene Huguenin
      • St Herblain, France, 44805
        • Institut de Cancérologie de l'ouest
      • Strasbourg, France, 67000
        • Hopital de Hautepierre
      • Toulouse, France, 31052
        • Institut Claudius Regaud

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.
surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Port site metastases
Time Frame: during 1 year post surgery
during 1 year post surgery
Morbidity: intraoperative and postoperative complications
Time Frame: during surgery and 1 year post surgery
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
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
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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

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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