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

Ovarian Cancer Clinical Trial

— 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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01905163
• Other study ID #: 2012-A01391-42
• Status: Completed
• Phase: Phase 2
• First received: July 9, 2013
• Last updated: July 18, 2017
• Start date: August 2013
• Est. completion date: July 2017

Study information

• Verified date: July 2017
• Source: Centre Jean Perrin
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 47
• Est. completion date: July 2017
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Fallopian Tube Cancer
• Fallopian Tube Neoplasms
• Ovarian Cancer
• Peritoneal Cavity Cancer

Intervention

Procedure:
• Tumor Debulking Surgery by laparoscopy

Locations

Country	Name	City	State
France	Institut de Cancerologie de l'Ouest, site Paul Papin	Angers
France	Centre Jean Perrin	Clermont-Ferrand
France	CHU Estaing	Clermont-Ferrand
France	Institut Paoli Calmettes	Marseille
France	Hôpital Européen Georges-Pompidou	Paris
France	Institut Curie	Paris
France	Institut Curie - Hôpital René Huguenin	Saint Cloud
France	Institut de Cancérologie de L'Ouest	St Herblain
France	Hôpital de Hautepierre	Strasbourg
France	Institut Claudius Regaud	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
Centre Jean Perrin

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	surgery
Secondary	Port site metastases		during 1 year post surgery
Secondary	Morbidity: intraoperative and postoperative complications		during surgery and 1 year post surgery
Secondary	Pain		during the hospital stay (an expected average of 5 days), at 1 week, 1 month, 3 and 6 months post surgery
Secondary	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
Secondary	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.	1 year post-surgery