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

April 11, 2016 updated by: Prof. Giovanni Scambia, Catholic University of the Sacred Heart
Phase II multicentric study

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Rome, Italy, 00168
        • Policlinico Agostino Gemelli
    • Rome
      • Rome,, Rome, Italy, 00100
        • Catholic University of Sacred Heart Rome,

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Laparoscopic Interval Debulking Surgery
Patients affected by advanced epithelial ovarian cancer already submitted to neoadjuvant chemotherapy with evidence of complete/partial response
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
Other Names:
  • Laparoscopy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Operative complication rate
Time Frame: 30 days
Intra- and post-operative complication rate of total laparoscopic/robotic interval debulking surgery
30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression Free survival
Time Frame: one year
time to recurrence
one year
Overall Survival
Time Frame: One year
time to last follow up/death
One year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Catholic University of the Sacred Heart

Collaborators

Fanfani, Francesco, M.D.
Fagotti, Anna, M.D.
Salvatore Gueli Alletti

Investigators

  • Principal Investigator: Giovanni Scambia, Prof, Catholic University of the Sacred Heart

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2013

Primary Completion (Actual)

February 1, 2015

Study Completion (Actual)

February 1, 2016

Study Registration Dates

First Submitted

June 17, 2014

First Submitted That Met QC Criteria

December 23, 2014

First Posted (Estimate)

December 24, 2014

Study Record Updates

Last Update Posted (Estimate)

April 13, 2016

Last Update Submitted That Met QC Criteria

April 11, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 10279/14

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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