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

Phase 2

Completed

• Conditions: Fallopian Tube Cancer; Ovarian Cancer; Peritoneal Cavity Cancer
• Interventions: Procedure: Tumor Debulking Surgery by laparoscopy

• Registration Number: NCT01905163
• Lead Sponsor: Centre Jean Perrin

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-07-09
• Study First Submitted QC: 2013-07-22
• Study First Posted: 2013-07-23
• Study Start: 2013-08
• Primary Completion: 2016-08
• Status Verified: 2017-07
• Study Completion: 2017-07
• Last Update Submitted: 2017-07-18
• Last Update Posted: 2017-07-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 47

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
laparoscopic management	Tumor Debulking Surgery by laparoscopy	Tumor Debulking Surgery by laparoscopy

Primary Outcome Measures

Name	Time	Method
the rate of conversion to laparotomy	surgery	Feasibility of the surgical laparoscopic management of interval debulking surgery will be assessed by the rate of conversion to laparotomy.

Secondary Outcome Measures

Name	Time	Method
Morbidity: intraoperative and postoperative complications	during surgery and 1 year post surgery
Port site metastases	during 1 year post surgery
Economic evaluation	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.
Pain	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	before surgery (an expected average of 7 days before surgery), 1 week , 1 month, 3 and 6 months post-surgery

Trial Locations

Locations (10)

Institut de Cancerologie de l'Ouest, site Paul Papin; 🇫🇷 Angers, France

CHU Estaing; 🇫🇷 Clermont-Ferrand, France

Centre Jean Perrin; 🇫🇷 Clermont-Ferrand, France

Institut Paoli Calmettes; 🇫🇷 Marseille, France

Institut de Cancérologie de L'Ouest; 🇫🇷 St Herblain, France

Institut Curie; 🇫🇷 Paris, France

Hôpital Européen Georges-Pompidou; 🇫🇷 Paris, France

Institut Curie - Hôpital René Huguenin; 🇫🇷 Saint Cloud, France

Institut Claudius Regaud; 🇫🇷 Toulouse, France

Hôpital de Hautepierre; 🇫🇷 Strasbourg, France