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

Centre Jean Perrin

Status and phase: Completed; Phase 2

Conditions: Fallopian Tube Cancer; Peritoneal Cavity Cancer; Ovarian Cancer

Treatments: Procedure: Tumor Debulking Surgery by laparoscopy

Study type: Interventional

Funder types: Other

Identifiers

NCT01905163

2012-A01391-42

Details and patient eligibility

About

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.

Enrollment: 47 patients

Sex: Female

Ages: 18+ years old

Volunteers: No 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.
• 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)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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47 participants in 1 patient group

laparoscopic management

Experimental group

Description:

Tumor Debulking Surgery by laparoscopy

Treatment:

Procedure: Tumor Debulking Surgery by laparoscopy