Brief Title
Feasibility of Interval Debulking Surgery by Laparoscopy for Peritoneal Carcinosis in Chemosensitive Patients
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.
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.
Study Phase
Phase 2
Study Type
Interventional
Primary Outcome
the rate of conversion to laparotomy
Secondary Outcome
Port site metastases
Condition
Ovarian Cancer
Intervention
Tumor Debulking Surgery by laparoscopy
Study Arms / Comparison Groups
laparoscopic management
Description: Tumor Debulking Surgery by laparoscopy
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Procedure
Estimated Enrollment
47
Start Date
August 2013
Completion Date
July 2017
Primary Completion Date
August 2016
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)
Gender
Female
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Christophe POMEL, Pr, ,
Location Countries
France
Location Countries
France
Administrative Informations
NCT ID
NCT01905163
Organization ID
2012-A01391-42
Responsible Party
Sponsor
Study Sponsor
Centre Jean Perrin
Study Sponsor
Christophe POMEL, Pr, Principal Investigator, Centre Jean Perrin
Verification Date
July 2017