Clinical trial NCT01905163: Feasibility of Interval Debulking Surgery by Laparoscopy for Peritoneal Carcinosis in Chemosensitive Patients
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Ovarian Cancer
Fallopian Tube Cancer
Peritoneal Cavity Cancer
Keywords: Laparoscopy, interval debulking surgery
Lead sponsor: Centre Jean Perrin
Sponsor class: OTHER
First posted: 2013-07-23
Enrollment: 47
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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)

Primary outcomes:
measure: the rate of conversion to laparotomy
timeFrame: surgery
Secondary outcomes:
measure: Port site metastases
timeFrame: during 1 year post surgery
measure: Morbidity: intraoperative and postoperative complications
timeFrame: during surgery and 1 year post surgery
measure: Pain
timeFrame: during the hospital stay (an expected average of 5 days), at 1 week, 1 month, 3 and 6 months post surgery
measure: Quality of life using EORTC QLQ-C30
timeFrame: before surgery (an expected average of 7 days before surgery), 1 week , 1 month, 3 and 6 months post-surgery
measure: Economic evaluation
timeFrame: 1 year post-surgery
Other outcomes:
Locations:
city: Angers
country: France
facility: Institut de Cancerologie de l'Ouest, site Paul Papin
city: Clermont-Ferrand
country: France
facility: CHU Estaing
city: Clermont-Ferrand
country: France
facility: Centre Jean Perrin
city: Marseille
country: France
facility: Institut Paoli Calmettes
city: Paris
country: France
facility: Institut Curie
city: Paris
country: France
facility: Hôpital Européen Georges-Pompidou
city: Saint Cloud
country: France
facility: Institut Curie - Hôpital René Huguenin
city: St Herblain
country: France
facility: Institut de Cancérologie de L'Ouest
city: Strasbourg
country: France
facility: Hôpital de Hautepierre
city: Toulouse
country: France
facility: Institut Claudius Regaud
Study officials:
affiliation: Centre Jean Perrin
name: Christophe POMEL, Pr
role: PRINCIPAL_INVESTIGATOR
References: