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NCT Number: NCT02324595

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

Phase II multicentric study

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Key information

Conditions

Stage IV Ovarian Carcinoma Adnexal Diseases Effects of Chemotherapy Endocrine Gland Neoplasms Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Gonadal Disorders Neoplasms Neoplasms by Site Ovarian Diseases Ovarian Neoplasms Peritoneal Cavity Cancer Urogenital Diseases Urogenital Neoplasms

Age range

18 year–90 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Catholic University of Sacred Heart Rome,, Rome, Italy

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Laparoscopic interval debulking surgery

Procedure

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

Primary outcomes

  1. Operative complication rate

    Time frame: 30 days

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

Secondary outcomes

  1. Progression Free survival

    Time frame: one year

    time to recurrence

  2. Overall Survival

    Time frame: One year

    time to last follow up/death

Sponsors and collaborators

Lead sponsor

Catholic University of the Sacred Heart

Other

Collaborators

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

Registry information

Acronym: MISSION

Important dates

Study start
2013
Primary completion
2015
Study completion
2016
First posted
Dec 24, 2014
Registry last updated
Apr 13, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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