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Stage IV Ovarian CarcinomaPhase 2MISSIONNCT02324595

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

A Phase 2 study testing Laparoscopic interval debulking surgery in people with Stage IV Ovarian Carcinoma and Effects of Chemotherapy, run by Catholic University of the Sacred Heart at 2 sites in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Phase II multicentric study Read more about this study

Who is it for?
Ages 18 to 90 years, women only
What is being tested?
Laparoscopic interval debulking surgery
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
2 sitesItaly
Study dates
Dec 2013to Feb 2016
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 90 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

2 sites in 1 country.

Italy2 sites

  • Catholic University of Sacred Heart Rome,

    Rome, Rome, 00100

  • Policlinico Agostino Gemelli

    Rome, Rome, 00168

Other trials in Italy

About this study

Phase II multicentric study

Read the 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.

Being tested
Laparoscopic interval debulking surgery
Keywords
Ovarian Cancer, Laparoscopy, Neoadjuvant Chemotherapy, Robotic, Interval Debulking Surgery
Medical subject headings
Ovarian Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Laparoscopic interval debulking surgeryProcedure or surgery

    Also called Laparoscopy

    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

Study groups in NCT02324595
Study groupRoleWhat they receive
Laparoscopic Interval Debulking SurgeryExperimentalPatients affected by advanced epithelial ovarian cancer already submitted to neoadjuvant chemotherapy with evidence of complete/partial response
Receives: Procedure: Laparoscopic interval debulking surgery

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Operative complication rate

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

    Measured: 30 days

Secondary outcomes (2)

  1. Progression Free survival

    time to recurrence

    Measured: one year

  2. Overall Survival

    time to last follow up/death

    Measured: One year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Dec 2014 (estimated)
  2. Study startDec 2013
  3. Primary completionFeb 2015
  4. Study completionFeb 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02324595
Sponsor's protocol ID
10279/14
Acronym
MISSION
Status last verified
Apr 2016
First submitted
17 Jun 2014
Last updated
13 Apr 2016
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 26529370

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Laparoscopic interval debulking surgery in people with Stage IV Ovarian Carcinoma and Effects of Chemotherapy, run by Catholic University of the Sacred Heart at 2 sites in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Operative complication rate (time frame: 30 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02324595, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2016.

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