Minimally Invasive Interval Debulking Surgery in Ovarian Neoplasm: a Feasibility Study (MISSION)
Primary Purpose
Stage IV Ovarian Carcinoma, Effects of Chemotherapy, Peritoneal Cavity Cancer
Status
Completed
Phase
Phase 2
Locations
Italy
Study Type
Interventional
Intervention
Laparoscopic interval debulking surgery
Sponsored by
About this trial
This is an interventional treatment trial for Stage IV Ovarian Carcinoma focused on measuring Ovarian Cancer, Laparoscopy, Neoadjuvant Chemotherapy, Robotic, Interval Debulking Surgery
Eligibility Criteria
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
Sites / Locations
- Catholic University of Sacred Heart Rome,
- Policlinico Agostino Gemelli
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Laparoscopic Interval Debulking Surgery
Arm Description
Patients affected by advanced epithelial ovarian cancer already submitted to neoadjuvant chemotherapy with evidence of complete/partial response
Outcomes
Primary Outcome Measures
Operative complication rate
Intra- and post-operative complication rate of total laparoscopic/robotic interval debulking surgery
Secondary Outcome Measures
Progression Free survival
time to recurrence
Overall Survival
time to last follow up/death
Full Information
NCT ID
NCT02324595
First Posted
June 17, 2014
Last Updated
April 11, 2016
Sponsor
Catholic University of the Sacred Heart
Collaborators
Fagotti, Anna, M.D., Fanfani, Francesco, M.D., Salvatore Gueli Alletti
1. Study Identification
Unique Protocol Identification Number
NCT02324595
Brief Title
Minimally Invasive Interval Debulking Surgery in Ovarian Neoplasm: a Feasibility Study
Acronym
MISSION
Official Title
Minimally Invasive Interval Debulking Surgery in Ovarian Neoplasm: a Feasibility Study
Study Type
Interventional
2. Study Status
Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
December 2013 (undefined)
Primary Completion Date
February 2015 (Actual)
Study Completion Date
February 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Catholic University of the Sacred Heart
Collaborators
Fagotti, Anna, M.D., Fanfani, Francesco, M.D., Salvatore Gueli Alletti
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Phase II multicentric study
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stage IV Ovarian Carcinoma, Effects of Chemotherapy, Peritoneal Cavity Cancer
Keywords
Ovarian Cancer, Laparoscopy, Neoadjuvant Chemotherapy, Robotic, Interval Debulking Surgery
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Laparoscopic Interval Debulking Surgery
Arm Type
Experimental
Arm Description
Patients affected by advanced epithelial ovarian cancer already submitted to neoadjuvant chemotherapy with evidence of complete/partial response
Intervention Type
Procedure
Intervention Name(s)
Laparoscopic interval debulking surgery
Other Intervention Name(s)
Laparoscopy
Intervention Description
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
Primary Outcome Measure Information:
Title
Operative complication rate
Description
Intra- and post-operative complication rate of total laparoscopic/robotic interval debulking surgery
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Progression Free survival
Description
time to recurrence
Time Frame
one year
Title
Overall Survival
Description
time to last follow up/death
Time Frame
One year
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Giovanni Scambia, Prof
Organizational Affiliation
Catholic University of the Sacred Heart
Official's Role
Principal Investigator
Facility Information:
Facility Name
Catholic University of Sacred Heart Rome,
City
Rome,
State/Province
Rome
ZIP/Postal Code
00100
Country
Italy
Facility Name
Policlinico Agostino Gemelli
City
Rome
ZIP/Postal Code
00168
Country
Italy
12. IPD Sharing Statement
Citations:
PubMed Identifier
26529370
Citation
Gueli Alletti S, Bottoni C, Fanfani F, Gallotta V, Chiantera V, Costantini B, Cosentino F, Ercoli A, Scambia G, Fagotti A. Minimally invasive interval debulking surgery in ovarian neoplasm (MISSION trial-NCT02324595): a feasibility study. Am J Obstet Gynecol. 2016 Apr;214(4):503.e1-503.e6. doi: 10.1016/j.ajog.2015.10.922. Epub 2015 Oct 31.
Results Reference
derived
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Minimally Invasive Interval Debulking Surgery in Ovarian Neoplasm: a Feasibility Study
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