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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
47
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
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.
Time frame: surgery
Port site metastases
Time frame: during 1 year post surgery
Morbidity: intraoperative and postoperative complications
Time frame: during surgery and 1 year post surgery
Pain
Time frame: 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
Time frame: before surgery (an expected average of 7 days before surgery), 1 week , 1 month, 3 and 6 months post-surgery
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.
Time frame: 1 year post-surgery
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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