Feasibility of Interval Debulking Surgery by Laparoscopy for Peritoneal Carcinosis in Chemosensitive Patients
Conditions
Ovarian Cancer - Fallopian Tube Cancer - Peritoneal Cavity Cancer
Conditions: official terms
Peritoneal Neoplasms
Conditions: Keywords
Laparoscopy, interval debulking surgery
Study Type
Interventional
Study Phase
Phase 2
Study Design
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Tumor Debulking Surgery by laparoscopy
Type: Procedure
Overall Status
Recruiting
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.
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)
Locations
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
Sponsors
Centre Jean Perrin
Source
Centre Jean Perrin
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page