Status:
COMPLETED
Feasibility of Interval Debulking Surgery by Laparoscopy for Peritoneal Carcinosis in Chemosensitive Patients
Lead Sponsor:
Centre Jean Perrin
Conditions:
Ovarian Cancer
Fallopian Tube Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
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-sen...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
August 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2017
Estimated Enrollment :
47 Patients enrolled
Trial Details
Trial ID
NCT01905163
Start Date
August 1 2013
End Date
July 1 2017
Last Update
July 19 2017
Active Locations (10)
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1
Institut de Cancerologie de l'Ouest, site Paul Papin
Angers, France, 49100
2
CHU Estaing
Clermont-Ferrand, France, 63003
3
Centre Jean Perrin
Clermont-Ferrand, France, 63011
4
Institut Paoli Calmettes
Marseille, France, 13009