Feasibility of Interval Debulking Surgery by Laparoscopy for Peritoneal Carcinosis in Chemosensitive Patients
Ovarian Cancer - Fallopian Tube Cancer - Peritoneal Cavity Cancer
Conditions: official terms
Peritoneal Neoplasms
Conditions: Keywords
Laparoscopy, interval debulking surgery
Study Type
Study Phase
Phase 2
Study Design
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Name: Tumor Debulking Surgery by laparoscopy
Type: Procedure
Overall Status
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Female
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)
Centre Jean Perrin
Clermont-Ferrand, France
Status: Recruiting
Contact: Christophe Pomel, Pr - 33473278121
CHU Estaing
Clermont-Ferrand, France
Status: Recruiting
Contact: Michel Canis, Pr
Institut Paoli Calmettes
Marseille, France
Status: Recruiting
Contact: Elisabeth CHEREAU EWALD, MD
Hôpital Européen Georges-Pompidou
Paris, France
Status: Recruiting
Contact: Fabrice Lecuru, Pr
Institut Curie
Paris, France
Status: Recruiting
Contact: Virginie FOURCHOTTE, Dr
Institut Curie - Hôpital René Huguenin
Saint Cloud, France
Status: Recruiting
Contact: Roman ROUZIER, Pr
Institut de Cancérologie de L'Ouest
St Herblain, France
Status: Not yet recruiting
Contact: Jean-Marc CLASSE, Pr
Hôpital de Hautepierre
Strasbourg, France
Status: Recruiting
Contact: Arnaud WATTIEZ, Pr
Institut Claudius Regaud
Toulouse, France
Status: Not yet recruiting
Contact: Gwénaël FERRON, MD
Start Date
July 2013
Completion Date
July 2016
Centre Jean Perrin
Centre Jean Perrin
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page