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

Study Overview
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Brief Summary
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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.

Official Title
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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.

Conditions
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Ovarian Cancer, Fallopian Tube Cancer, Peritoneal Cavity Cancer

Intervention / Treatment
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* Procedure: Tumor Debulking Surgery by laparoscopy


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: laparoscopic management<br>Tumor Debulking Surgery by laparoscopy | Procedure: Tumor Debulking Surgery by laparoscopy<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Port site metastases |  | during 1 year post surgery | 
| Morbidity: intraoperative and postoperative complications |  | during surgery and 1 year post surgery | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Laparoscopy, interval debulking surgery