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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02324595
Other study ID # 10279/14
Secondary ID
Status Completed
Phase Phase 2
First received June 17, 2014
Last updated April 11, 2016
Start date December 2013
Est. completion date February 2016

Study information

Verified date April 2016
Source Catholic University of the Sacred Heart
Contact n/a
Is FDA regulated No
Health authority Italy: Ethics Committee
Study type Interventional

Clinical Trial Summary

Phase II multicentric study


Description:

The aim of this prospective Phase II multicentric study is to assess feasibility and early complications rate of "total laparoscopic/robotic" interval debulking surgery in patients with a clinical complete/partial response to neoadjuvant chemotherapy for advanced ovarian cancer.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date February 2016
Est. primary completion date February 2015
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 90 Years
Eligibility Inclusion Criteria:

- Age >18 years,

- Advanced ovarian cancer submitted to neoadjuvant chemotherapy,

- Clinical or serological complete/partial response (RECIST; GCIG),

- PS = 2 (ECOG),

- Informed consent

Exclusion Criteria:

- Borderline and non-epithelial ovarian tumors,

- Stable/progressive disease,

- ASA 3-4,

- Severe cardiopulmonary disease,

- BMI > 40

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

Procedure:
Laparoscopic interval debulking surgery
Diagnostic laparoscopy with a careful exploration of peritoneal cavity: if available a 5 mm "flexible tip" videolaparoscope will be used to explore all peritoneal recesses.For eligible patients,will be placed 3 5mm trocar in standard position for pelvic surgery:cytoreduction will consist in total/radical hysterectomy,bilateral salpingo-oophorectomy,radical omentectomy.If needed pelvic/upper peritonectomy will be performed:in these cases additional trocar can be placed in right or left subcostal spaces. All surgical procedure requested will have be carried out by laparoscopy/robotic or by laparotomy,in case of increased surgical risk or technical impossibility:the case will be registered as laparotomic conversion.At the end of surgical procedures residual tumor will be registered

Locations

Country Name City State
Italy Policlinico Agostino Gemelli Rome
Italy Catholic University of Sacred Heart Rome, Rome, Rome

Sponsors (4)

Lead Sponsor Collaborator
Catholic University of the Sacred Heart Fagotti, Anna, M.D., Francesco Fanfani, Salvatore Gueli Alletti

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary Operative complication rate Intra- and post-operative complication rate of total laparoscopic/robotic interval debulking surgery 30 days Yes
Secondary Progression Free survival time to recurrence one year Yes
Secondary Overall Survival time to last follow up/death One year Yes
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