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

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ClinicalTrials.gov Identifier: NCT02324595
Recruitment Status : Completed
First Posted : December 24, 2014
Last Update Posted : April 13, 2016
Sponsor:
Collaborators:
Fagotti, Anna, M.D.
Fanfani, Francesco, M.D.
Salvatore Gueli Alletti
Information provided by (Responsible Party):
Prof. Giovanni Scambia, Catholic University of the Sacred Heart

Brief Summary:
Phase II multicentric study

Condition or disease Intervention/treatment Phase
Stage IV Ovarian Carcinoma Effects of Chemotherapy Peritoneal Cavity Cancer Procedure: Laparoscopic interval debulking surgery Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Minimally Invasive Interval Debulking Surgery in Ovarian Neoplasm: a Feasibility Study
Study Start Date : December 2013
Actual Primary Completion Date : February 2015
Actual Study Completion Date : February 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ovarian Cancer

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 Name: Laparoscopy




Primary Outcome Measures :
  1. Operative complication rate [ Time Frame: 30 days ]
    Intra- and post-operative complication rate of total laparoscopic/robotic interval debulking surgery


Secondary Outcome Measures :
  1. Progression Free survival [ Time Frame: one year ]
    time to recurrence

  2. Overall Survival [ Time Frame: One year ]
    time to last follow up/death



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02324595


Locations
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Italy
Catholic University of Sacred Heart Rome,
Rome,, Rome, Italy, 00100
Policlinico Agostino Gemelli
Rome, Italy, 00168
Sponsors and Collaborators
Catholic University of the Sacred Heart
Fagotti, Anna, M.D.
Fanfani, Francesco, M.D.
Salvatore Gueli Alletti
Investigators
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Principal Investigator: Giovanni Scambia, Prof Catholic University of the Sacred Heart
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Prof. Giovanni Scambia, Director, Dip per la Tutela della Salute della Donna e della Vita Nascente, del Bambino e dell'Adolescente, Catholic University of the Sacred Heart
ClinicalTrials.gov Identifier: NCT02324595    
Other Study ID Numbers: 10279/14
First Posted: December 24, 2014    Key Record Dates
Last Update Posted: April 13, 2016
Last Verified: April 2016
Keywords provided by Prof. Giovanni Scambia, Catholic University of the Sacred Heart:
Ovarian Cancer
Laparoscopy
Neoadjuvant Chemotherapy
Robotic
Interval Debulking Surgery
Additional relevant MeSH terms:
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Ovarian Neoplasms
Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders