ClinicalTrials.gg
CompletedNCT01709487Updated Feb 24, 2016

Feasibility Study of HIPEC for Patients With Stage III or Only Pleural Stage IV Ovarian Carcinoma in First Line Therapy

A Phase 1/2 interventional study of HIPEC in Ovarian Carcinoma, Fallopian Tube Carcinoma and Primary Peritoneal Carcinoma, sponsored by Jules Bordet Institute. Completed at 2 sites in Belgium. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-02-24.

Sponsored by Jules Bordet Institute · Phase 1/2, Interventional, and Treatment

Phase
Phase 1/2
Study type
Interventional
Enrollment
19
Allocation
Not applicable
Ages
18 Years and older
Sex
Female
01

Study summary

First line treatment for advanced ovarian carcinoma hyperthermic intraperitoneal chemotherapy (HIPEC) after optimal debulking.

Read the detailed description

Addition of HIPEC to the standard first line treatment of ovarian carcinoma.

02

Conditions studied

  • Ovarian Carcinoma
  • Fallopian Tube Carcinoma
  • Primary Peritoneal Carcinoma

Keywords

  • HIPEC
  • ovarian carcinoma
  • Bordet
03

In context

Ovarian Neoplasms

2,757 studies on the registry are indexed under Ovarian Neoplasms; 735 are open to participants now.

This study's enrollment of 19 is below the median of 59 across 2,075 interventional studies indexed under Ovarian Neoplasms.

Browse Ovarian Neoplasms studies →

Lead sponsor

Jules Bordet Institute is the lead sponsor of 106 studies on the registry; 28 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • stage III or only pleural stage IV ovarian carcinoma first line treatment

Exclusion criteria

Exclusion Criteria:

  • incomplete surgery poor performance status bad general condition
05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
19 participants (actual)

Study arms

  • Experimental
    HIPEC surgery with chemotherapy

    * 3 courses of pre-operative chemotherapy: carboplatin AUC = 5 IV + paclitaxel 175 mg/m2 IV every 3 weeks * Debulking surgery * HIPEC with cisplatin 50 mg/m2 intraperitoneally at the end of surgery * 3 courses of post-operative chemotherapy: carboplatin AUC = 5 IV + paclitaxel 175 mg/m2 IV every 3 weeks

    Procedure: HIPEC

Interventions

  • ProcedureHIPEC

    HIPEC with cisplatin 50 mg/m2 intraperitoneally at the end of surgery

06

What researchers measure

Primary outcomes

  1. mortality rate

    We will record the mortality rate of our interventions: 3 cycles of pre-operative chemotherapy, surgery and HIPEC, 3 cycles of post-operative chemotherapy.

    Time frame: 24 weeks

Secondary outcomes

  1. progression free survival

    Time frame: 3 years

  2. Overall survival

    Time frame: 3 years

07

Study locations

2 sites
  • Hopital de la Citadelle
    Liège, Liège 4000, Belgium
  • Institut Jules Bordet
    Brussels, 1000, Belgium
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of May 2010, a primary completion of Oct 2015 and a completion of Oct 2015. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 12, 2012
First posted
Oct 18, 2012
Start
May 2010
Primary completionActual
Oct 2015
CompletionActual
Oct 2015
Last update
Feb 24, 2016
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 24, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01709487
Responsible party
Sponsor
First posted
Oct 18, 2012
Start date
May 2010
Primary completion
Oct 2015
Completion
Oct 2015
Last update
Feb 24, 2016

Study contacts

Joseph Kerger, M.D.
principal investigator · Institut Jules Bordet, Brussels, Belgium.
Frédéric Goffin, M.D.
principal investigator · Hopital de la Citadelle, Liège, Belgium.

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2014. You cannot join it, but the record below documents what was studied.

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