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Feasibility of Interval Debulking Surgery by Laparoscopy for Peritoneal Carcinosis in Chemosensitive Patients | Clinical Trials | Clareo Health

COMPLETEDPHASE2

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

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.

NCT01905163•Centre Jean Perrin

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

FEMALE

Healthy Volunteers

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.
+1 more criteria

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 (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 Curie

Paris, France

Hôpital Européen Georges-Pompidou

Paris, France

Institut Curie - Hôpital René Huguenin

Saint-Cloud, France

Institut de Cancérologie de L'Ouest

Saint-Herblain, France

Hôpital de Hautepierre

Strasbourg, France

Institut Claudius Regaud

Toulouse, France

Key Dates

Start Date

August 1, 2013

Primary Completion Date

August 1, 2016

Completion Date

July 1, 2017

Last Updated

July 19, 2017

Enrollment

ACTUAL participants

Conditions

Ovarian CancerFallopian Tube CancerPeritoneal Cavity Cancer

Interventions

Tumor Debulking Surgery by laparoscopy

PROCEDURE

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 19, 2017Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

IACS-6274 With or Without Bevacizumab and Paclitaxel for the Treatment of Advanced Solid Tumors

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