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NCT01376752Active, not recruitingPhase 3

Hyperthermic Intra-Peritoneal Chemotherapy (HIPEC) in Relapse Ovarian Cancer Treatment

A Phase III Randomized Study Evaluating Hyperthermic Intra-Peritoneal Chemotherapy (HIPEC) in the Treatment of Relapse Ovarian Cancer

Source: ClinicalTrials.gov · Last updated 20 May 2026

Brief summary (registry, in English)

CHIPOR hypothesis is that the adjunction of platinum HIPEC in first relapsed epithelial ovarian cancer is able to improve the median Overall Survival (OS) by 12 months. In that hypothesis, with alpha risk of 5%, a power beta of 80%, during a 3 years period of inclusion and a 3 years follow-up, the number of patients to include is 404. Taking into account a 10% failure, an overall number of 444 patients is required.

Status (registry)
Active, not recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
415 (actual)
First submitted
28 Mar 2011
Start date
26 Apr 2011
Primary completion date
8 Jan 2023
Lead sponsor
UNICANCER
NCT number
NCT01376752
EU CT number
2024-517390-24-00
EudraCT number
2010-023035-42

What you commit to

  • Study type: Interventional · Phase 3
  • Participants enrolled: 415
  • From 26 Apr 2011 to the primary completion date, 8 Jan 2023
  • 34 sites in 3 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Patient with other concurrent severe life threatening disease
  • The need to perform more than two segmental digestive resections during the CRS +/- HIPEC surgery
  • Patient already treated with HIPEC for the ovarian cancer

Other illness

  • Previous cancer in the last 5 years (except cutaneous baso-cellular epithelioma or uterine peripheral epithelioma)
  • Hypersensitivity to Platinum compound
  • Any progressive disease during the IV systemic second-line chemotherapy (platine-based)
  • Incomplete cytoreductive surgery with macroscopical residual disease (Sugarbaker \> CC1)
  • Ovarian tumor other than Epithelioma Ovarian Cancer
  • Uncontrolled infection
  • Patients with any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
  • Clinically significant cardiovascular disease contraindicating the hyper hydratation, which is necessary for HIPEC

Age

  • Patient age \<18 years

Other

  • Distant metastasis
  • Use of anti-angiogenic treatment
  • Early relapse: less than 6 mois after the end of the first treatment
  • Individual deprived of liberty or placed under the authority of a tutor

Who the study is looking for

  • Patient age ≥ 18 years
  • Performance Status WHO \< 2
  • Initially treated for Epithelial Ovarian Carcinoma
  • Patient with only peritoneal relapse occurred at least 6 month from the initial treatment, resectable without distant metastasis (with the exception of communicating pleura effusion, sensitive to platine-based second line chemotherapy and resectable lymph-nodes in the groin or retro peritoneal)
  • Platinum based second-line chemotherapy before surgery with either carboplatine-paclitaxel, or carboplatine-caelyx
  • Complete cytoreductive surgery
  • The surgery has to be planned 5 to 8 weeks from the last 2nd of chemotherapy
  • No hepatic failure, bilirubin ≤ 1,5 time the Normal limit, ASAT and ALAT ≤ 3 time the Upper Normal Limit
  • No Renal insufficiency (serum creatinine \< 1,5 time the normal limit, creatinine clearance \> 80 mL/min). calculated with MDRD method
  • Hematology function: PNN ≥ 1,5x10⁹/L, platelets ≥ 100x10⁹/L
  • No contraindication to general anaesthesia for heavy surgery
  • Patients having read, signed and dated Informed consent before any study procedure
  • Childbearing patients have to take appropriate contraceptive methods during the treatment and until 6 months after the treatment

Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (34)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Institut Jules Bordet
Coordinator of this site? Confirm its status
BrusselsBelgiumUnknown status
Hospital Universitari Germans Trias i Pujol
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BadalonaSpainUnknown status
Centre Hospitalier Universitaire Amiens Picardie
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Amiens Cedex 1FranceRecruiting
INSTITUT DE CANCEROLOGIE DE L’OUEST (ICO), SITE P PAPIN
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ANGERSFranceRecruiting
Institut Bergonie
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BordeauxFranceRecruiting
Clinique Pasteur Lanroze
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BrestFranceRecruiting
Centre Hospitalier Privé de Brest - Keraudren
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BrestFranceRecruiting
Centre Francois Baclesse
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Caen Cedex 5FranceRecruiting
Centre Jean Perrin
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Clermont Ferrand Cedex1FranceRecruiting
Centre Hospitalier Universitaire de Dijon
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DijonFranceRecruiting
Centre Hospitalier Universitaire Grenoble Alpes
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Grenoble Cedex 9FranceRecruiting
Pôle Santé Sud
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Le MansFranceRecruiting
Clinique Victor Hugo
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Le Mans Cedex 2FranceRecruiting
Centre Oscar Lambret
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LilleFranceRecruiting
Hospital Claude Huriez
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Lille CedexFranceRecruiting
CHU Dupuytren
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LimosgesFranceRecruiting
Centre Leon Berard
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LyonFranceRecruiting
Hôpital La Timone - APHM
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MarseilleFranceRecruiting
Institut Paoli-Calmettes
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MarseilleFranceRecruiting
Institut Régional Cancer Montpellier - ICM Val d'Aurelle
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MONTPELLIERFranceRecruiting
Hôpital Archet 2
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NiceFranceRecruiting
Institut Curie
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ParisFranceRecruiting
Assistance Publique Hopitaux de Paris
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ParisFranceRecruiting
Hôpital Européen Georges Pompidou
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ParisFranceRecruiting
Hopital Tenon
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Paris Cedex 20FranceRecruiting
Centre Hospitalier Lyon-Sud
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Pierre-BéniteFranceRecruiting
CHRU de Poitiers La Miletrie
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PoitiersFranceRecruiting
INSTITUT DE CANCEROLOGIE DE L’OUEST (ICO) RENE GAUDUCHAU
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SAINT-HERBLAINFranceRecruiting
Unite De Recherche Clinique HIA Begin
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Saint-MandeFranceRecruiting
Centre Hospitalier Universitaire De Saint Etienne
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St Etienne Cedex 2FranceRecruiting
Hôpital de Hautepierre - Hôpitaux Universitaires de Strasbourg
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StrasbourgFranceRecruiting
Oncopole Claudius Regaud
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Toulouse Cedex 9FranceRecruiting
Institut De Cancerologie De Lorraine
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Vandouvre Les NancyFranceRecruiting
Institut Gustave Roussy
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VillejuifFranceRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.