NCT01709487

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
19

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started May 2010

Longer than P75 for phase_1

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

May 1, 2010

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

October 12, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 18, 2012

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
Last Updated

February 24, 2016

Status Verified

July 1, 2014

Enrollment Period

5.4 years

First QC Date

October 12, 2012

Last Update Submit

February 23, 2016

Conditions

Ovarian CarcinomaFallopian Tube CarcinomaPrimary Peritoneal Carcinoma

Keywords

HIPECovarian carcinomaBordet

Outcome Measures

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.

    24 weeks

Secondary Outcomes (2)

  • progression free survival

    3 years

  • Overall survival

    3 years

Study Arms (1)

HIPEC surgery with chemotherapy

EXPERIMENTAL

* 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

HIPECPROCEDURE

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

HIPEC surgery with chemotherapy

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

  • incomplete surgery poor performance status bad general condition

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hopital de la Citadelle

Liège, Liège, 4000, Belgium

Location

Institut Jules Bordet

Brussels, 1000, Belgium

Location

MeSH Terms

Conditions

Ovarian NeoplasmsFallopian Tube Neoplasms

Interventions

Hyperthermic Intraperitoneal Chemotherapy

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 DisordersFallopian Tube Diseases

Intervention Hierarchy (Ancestors)

Chemotherapy, AdjuvantCombined Modality TherapyTherapeuticsDrug TherapyHyperthermia, Induced

Study Officials

  • Joseph Kerger, M.D.

    Institut Jules Bordet, Brussels, Belgium.

    PRINCIPAL INVESTIGATOR

  • Frédéric Goffin, M.D.

    Hopital de la Citadelle, Liège, Belgium.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 12, 2012

First Posted

October 18, 2012

Study Start

May 1, 2010

Primary Completion

October 1, 2015

Study Completion

October 1, 2015

Last Updated

February 24, 2016

Record last verified: 2014-07

Locations

BE(2)