Minimally Invasive Interval Debulking Surgery in Ovarian Neoplasm: a Feasibility Study

Peritoneal Cavity Cancer Clinical Trial

— MISSION  

Official title:

Minimally Invasive Interval Debulking Surgery in Ovarian Neoplasm: a Feasibility Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02324595
• Other study ID #: 10279/14
• 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

Related Conditions & MeSH terms

• Effects of Chemotherapy
• Ovarian Neoplasms
• Peritoneal Cavity Cancer
• Peritoneal Neoplasms
• Stage IV Ovarian Carcinoma

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