Skip to main content
MedPath Trial logoMedPath TrialMedPath Trial Home
Clinical Trials/NCT01905163
NCT01905163CompletedPhase 2

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.

Centre Jean Perrin20 sites in 1 country47 target enrollmentStarted: August 1, 2013Last updated:
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
Conditions
Interventions

Trial Snapshot

Phase
Phase 2
Status
Completed
Sponsor
Enrollment
47
Locations
20
Primary Endpoint
the rate of conversion to laparotomy
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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-sensitive patients with advanced ovarian, tubal cancer or primary peritoneal.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
Female
Accepts Healthy Volunteers
No

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)

Arms & Interventions

laparoscopic management

Experimental

Tumor Debulking Surgery by laparoscopy

Intervention: Tumor Debulking Surgery by laparoscopy (Procedure)

Outcomes

Primary Outcomes

the rate of conversion to laparotomy

Time Frame: surgery

Feasibility of the surgical laparoscopic management of interval debulking surgery will be assessed by the rate of conversion to laparotomy.

Secondary Outcomes

  • Port site metastases(during 1 year post surgery)
  • Morbidity: intraoperative and postoperative complications(during surgery and 1 year post surgery)
  • Economic evaluation(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)

Investigators

Sponsor
Centre Jean Perrin
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (20)

Loading locations...

Similar Trials

Unknown
Not Applicable
Magnetically Controlled Capsule Endoscope System in Stomach Examination of Moderately and Severely Obese PatientsObesity
NCT05459714Changhai Hospital30
Unknown
Phase 2
Extracorporeal Photopheresis Using Theraflex ECP™ for Patients With Refractory Chronic Graft Versus Host Disease (cGVHD)Refractory Chronic Graft Versus Host Disease (cGVHD)
NCT03083574Jules Bordet Institute100
Completed
Phase 1
RENABLATE-II Feasibility Study of Catheter Based Renal Denervation to Treat Resistant Hypertension - 157Hypertension, Renal
NCT02095691Biosense Webster, Inc.19
Completed
Phase 4
Prospective Clinicogenomic ProgramNon-Small Cell Lung Cancer (NSCLC)Small-Cell Lung Cancer (SCLC)
NCT04180176Genentech, Inc.945
Terminated
Not Applicable
To Determine the Feasibility of a Fidaxomicin Study in Neonates and to Assess C. Difficile (Clostridium Difficile) Involvement in the PathogenesisClostridium Difficile
NCT01533844Astellas Pharma Europe B.V.1