Feasibility of Interval Debulking Surgery by Laparoscopy for Peritoneal Carcinosis in Chemosensit… (NCT01905163) | Clinical Trial Compass
CompletedPhase 2
Feasibility of Interval Debulking Surgery by Laparoscopy for Peritoneal Carcinosis in Chemosensitive Patients
France47 participantsStarted 2013-08
Plain-language 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.
Who can participate
Age range18 Years
SexFEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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)