NCT02324595

Brief Summary

Phase II multicentric study

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Dec 2013

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2013

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

June 17, 2014

Completed
6 months until next milestone

First Posted

Study publicly available on registry

December 24, 2014

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2016

Completed
Last Updated

April 13, 2016

Status Verified

April 1, 2016

Enrollment Period

1.2 years

First QC Date

June 17, 2014

Last Update Submit

April 11, 2016

Conditions

Stage IV Ovarian CarcinomaEffects of ChemotherapyPeritoneal Cavity Cancer

Keywords

Ovarian CancerLaparoscopyNeoadjuvant ChemotherapyRoboticInterval Debulking Surgery

Outcome Measures

Primary Outcomes (1)

  • Operative complication rate

    Intra- and post-operative complication rate of total laparoscopic/robotic interval debulking surgery

    30 days

Secondary Outcomes (2)

  • Progression Free survival

    one year

  • Overall Survival

    One year

Study Arms (1)

Laparoscopic Interval Debulking Surgery

EXPERIMENTAL

Patients affected by advanced epithelial ovarian cancer already submitted to neoadjuvant chemotherapy with evidence of complete/partial response

Procedure: Laparoscopic interval debulking surgery

Interventions

Laparoscopic interval debulking surgeryPROCEDURE

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

Also known as: Laparoscopy
Laparoscopic Interval Debulking Surgery

Eligibility Criteria

Age18 Years - 90 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age \>18 years,
  • Advanced ovarian cancer submitted to neoadjuvant chemotherapy,
  • Clinical or serological complete/partial response (RECIST; GCIG),
  • PS ≤ 2 (ECOG),
  • Informed consent

You may not qualify if:

  • Borderline and non-epithelial ovarian tumors,
  • Stable/progressive disease,
  • ASA 3-4,
  • Severe cardiopulmonary disease,
  • BMI \> 40

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Catholic University of Sacred Heart Rome,

Rome, Rome, 00100, Italy

Location

Policlinico Agostino Gemelli

Rome, Rome, 00168, Italy

Location

Related Publications (1)

  • 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.

    PMID: 26529370DERIVED

MeSH Terms

Conditions

Ovarian Neoplasms

Interventions

Laparoscopy

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal Disorders

Intervention Hierarchy (Ancestors)

EndoscopyDiagnostic Techniques, SurgicalDiagnostic Techniques and ProceduresDiagnosisMinimally Invasive Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Giovanni Scambia, Prof

    Catholic University of the Sacred Heart

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Dip per la Tutela della Salute della Donna e della Vita Nascente, del Bambino e dell'Adolescente

Study Record Dates

First Submitted

June 17, 2014

First Posted

December 24, 2014

Study Start

December 1, 2013

Primary Completion

February 1, 2015

Study Completion

February 1, 2016

Last Updated

April 13, 2016

Record last verified: 2016-04

Locations

IT(2)