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Feasibility of Interval Debulking Surgery by Laparoscopy for Peritoneal Carcinosis in Chemosensitive Patients (CILOVE)

Primary Purpose

Ovarian Cancer, Fallopian Tube Cancer, Peritoneal Cavity Cancer

Status
Completed
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
Tumor Debulking Surgery by laparoscopy
Sponsored by
Centre Jean Perrin
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ovarian Cancer focused on measuring Laparoscopy, interval debulking surgery

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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)

Sites / Locations

  • Institut de Cancerologie de l'Ouest, site Paul Papin
  • CHU Estaing
  • Centre Jean Perrin
  • Institut Paoli Calmettes
  • Institut Curie
  • Hôpital Européen Georges-Pompidou
  • Institut Curie - Hôpital René Huguenin
  • Institut de Cancérologie de L'Ouest
  • Hôpital de Hautepierre
  • Institut Claudius Regaud

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

laparoscopic management

Arm Description

Tumor Debulking Surgery by laparoscopy

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Port site metastases
Morbidity: intraoperative and postoperative complications
Pain
Quality of life using EORTC QLQ-C30
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.

Full Information

First Posted
July 9, 2013
Last Updated
July 18, 2017
Sponsor
Centre Jean Perrin
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1. Study Identification

Unique Protocol Identification Number
NCT01905163
Brief Title
Feasibility of Interval Debulking Surgery by Laparoscopy for Peritoneal Carcinosis in Chemosensitive Patients
Acronym
CILOVE
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.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
August 2013 (undefined)
Primary Completion Date
August 2016 (Actual)
Study Completion Date
July 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Jean Perrin

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Cancer, Fallopian Tube Cancer, Peritoneal Cavity Cancer
Keywords
Laparoscopy, interval debulking surgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
47 (Actual)

8. Arms, Groups, and Interventions

Arm Title
laparoscopic management
Arm Type
Experimental
Arm Description
Tumor Debulking Surgery by laparoscopy
Intervention Type
Procedure
Intervention Name(s)
Tumor Debulking Surgery by laparoscopy
Primary Outcome Measure Information:
Title
the rate of conversion to laparotomy
Description
Feasibility of the surgical laparoscopic management of interval debulking surgery will be assessed by the rate of conversion to laparotomy.
Time Frame
surgery
Secondary Outcome Measure Information:
Title
Port site metastases
Time Frame
during 1 year post surgery
Title
Morbidity: intraoperative and postoperative complications
Time Frame
during surgery and 1 year post surgery
Title
Pain
Time Frame
during the hospital stay (an expected average of 5 days), at 1 week, 1 month, 3 and 6 months post surgery
Title
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
Title
Economic evaluation
Description
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.
Time Frame
1 year post-surgery

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christophe POMEL, Pr
Organizational Affiliation
Centre Jean Perrin
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institut de Cancerologie de l'Ouest, site Paul Papin
City
Angers
ZIP/Postal Code
49100
Country
France
Facility Name
CHU Estaing
City
Clermont-Ferrand
ZIP/Postal Code
63003
Country
France
Facility Name
Centre Jean Perrin
City
Clermont-Ferrand
ZIP/Postal Code
63011
Country
France
Facility Name
Institut Paoli Calmettes
City
Marseille
ZIP/Postal Code
13009
Country
France
Facility Name
Institut Curie
City
Paris
ZIP/Postal Code
75005
Country
France
Facility Name
Hôpital Européen Georges-Pompidou
City
Paris
ZIP/Postal Code
75015
Country
France
Facility Name
Institut Curie - Hôpital René Huguenin
City
Saint Cloud
ZIP/Postal Code
92210
Country
France
Facility Name
Institut de Cancérologie de L'Ouest
City
St Herblain
ZIP/Postal Code
44805
Country
France
Facility Name
Hôpital de Hautepierre
City
Strasbourg
ZIP/Postal Code
67000
Country
France
Facility Name
Institut Claudius Regaud
City
Toulouse
ZIP/Postal Code
31052
Country
France

12. IPD Sharing Statement

Learn more about this trial

Feasibility of Interval Debulking Surgery by Laparoscopy for Peritoneal Carcinosis in Chemosensitive Patients

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