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Active, not recruitingNCT01376752CHIPORUpdated May 20, 2026

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

A Phase 3 interventional study of Maximal cytoreductive surgery and HIPEC in Ovarian Epithelial Cancer Recurrent, sponsored by UNICANCER. Active, not recruiting at 33 sites in 3 countries. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-20.

Sponsored by UNICANCER · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
415
Allocation
Randomized
Ages
18 Years and older
Sex
Female
01

Study summary

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.

Read the detailed description

The patient received before the surgery a second line chemotherapy, platinum-based regimen with either carboplatine-paclitaxel, or carboplatine-caelyx. At the end of the six courses IV chemotherapy, if the disease is still responding and if a complete cytoreductive surgery seems possible, the patient is included after signed informed consent and will be operated 5 to 8 weeks after the last second-line chemotherapy cycle.

So, during the surgery the patient will be randomized if the complete cytoreductive surgery is really done and will then receive:

  • either treatment A = maximal cytoreductive surgery without HIPEC
  • or treatment B = maximal cytoreductive surgery with HIPEC

The HIPEC will be done at the end of the surgery. At the end of cytoreductive surgery, tumor residual disease must be null or very limited (Sugarbaker completeness cytoreduction: CC0 (no residual)-CC1 (residual \< 0.25cm).

Two methods will be used for the HIPEC: Open or closed abdomen, depends on the site practice. Each site will use the same method during the study for all included patients.

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Conditions studied

  • Ovarian Epithelial Cancer Recurrent
03

In context

Lead sponsor

UNICANCER is the lead sponsor of 215 studies on the registry; 52 are open to participants now.

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

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Who can participate

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

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • Patient age \<18 years
  • Previous cancer in the last 5 years (except cutaneous baso-cellular epithelioma or uterine peripheral epithelioma)
  • Hypersensitivity to Platinum compound
  • Distant metastasis
  • Use of anti-angiogenic treatment
  • Patient with other concurrent severe life threatening disease
  • The need to perform more than two segmental digestive resections during the CRS +/- HIPEC surgery
  • Any progressive disease during the IV systemic second-line chemotherapy (platine-based)
  • Incomplete cytoreductive surgery with macroscopical residual disease (Sugarbaker > CC1)
  • Early relapse: less than 6 mois after the end of the first treatment
  • 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
  • Patient already treated with HIPEC for the ovarian cancer
  • Individual deprived of liberty or placed under the authority of a tutor
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Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
415 participants (actual)

Study arms

  • Active comparator
    maximal cytoreductive surgery without HIPEC

    The participant will have a regular cytoreductive surgery without the adjunction of HIPEC.

    Procedure: Maximal cytoreductive surgery

  • Experimental
    maximal cytoreductive surgery with HIPEC

    The participant will have a regular cytoreductive surgery, then the adjunction of HIPEC: hyperthermic cisplatin will be used at 75mg/m²

    Procedure: Maximal cytoreductive surgery · Drug: HIPEC

Interventions

  • ProcedureMaximal cytoreductive surgery

    Maximal cytoreductive surgery

  • DrugHIPEC

    HIPEC: Hyperthermic Intra-PEritoneal Chemotherapy. Administration of cisplatin at 75mg/m²

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What researchers measure

Primary outcomes

  1. overall survival

    Follow-up of 4 years.

    Time frame: from randomization to death (up to 4 years)

Secondary outcomes

  1. relapse free survival

    Follow-up of 4 years.

    Time frame: from randomization to relapse (up to 4 years)

07

Study locations

33 sites
  • Institut Jules Bordet
    Brussels, Belgium
  • CHU d'AMIENS
    Amiens, France
  • Centre Paul Papin
    Angers, 49933, France
  • Institut Bergonie
    Bordeaux, 33076, France
  • Clinique Pasteur
    Brest, France
  • Polyclinique Kéraudren
    Brest, France
  • Centre Francois Baclesse
    Caen, 14076, France
  • Centre Jean Perrin
    Clermont-Ferrand, 63011, France
  • Centre hospitalier de Dijon
    Dijon, France
  • CHU de Grenoble
    Grenoble, France
  • Clinique Victor Hugo
    Le Mans, France
  • Pôle Santé Sud
    Le Mans, France
  • Centre Oscar Lambret
    Lille, 59020, France
  • CHU de Lille
    Lille, France
  • Centre Hospitalier Universitaire Dupuytren
    Limoges, 87042, France
  • Centre Leon Berard
    Lyon, 69373, France
  • Centre Hopsitalier Lyon Sud
    Lyon, 69495, France
  • Institut Paoli Calmettes
    Marseille, 13273, France
  • AP-HM - Hôpital de la Timone
    Marseille, France
  • CRLC Val d'Aurelle
    Montpellier, 34298, France
  • Centre Hospitalier Universitaire Nice
    Nice, 06202, France
  • Hopital Lariboisiere
    Paris, 75010, France
  • Hopital Tenon
    Paris, 75020, France
  • Hôpital Européen Georges Pompidou
    Paris, France
  • Institut Curie
    Paris, France
  • CHU - Hôpital de la Milétrie
    Poitiers, France
  • Centre Hospitalier Universitaire Saint Etienne- Hopital Nord
    Saint-Etienne, 42055, France
  • Ico-Centre Rene Gauducheau
    Saint-Herblain, 44805, France
  • CHU Hautepierre
    Strasbourg, 67098, France
  • Institut Claudius Regaud
    Toulouse, 31052, France
  • Centre Alexis Vautrin
    Vandœuvre-lès-Nancy, 54511, France
  • Institut Gustave Roussy
    Villejuif, 94805, France
  • Hospital Universitari Germans Trias I Pujol
    Badalona, Spain
08

References and documents

Publications

  • Brigand C, Monneuse O, Mohamed F, Sayag-Beaujard AC, Isaac S, Gilly FN, Glehen O. Peritoneal mesothelioma treated by cytoreductive surgery and intraperitoneal hyperthermic chemotherapy: results of a prospective study. Ann Surg Oncol. 2006 Mar;13(3):405-12. doi: 10.1245/ASO.2006.05.041. Epub 2006 Jan 30. PubMed 16485159 ↗
  • Armstrong DK, Bundy B, Wenzel L, Huang HQ, Baergen R, Lele S, Copeland LJ, Walker JL, Burger RA; Gynecologic Oncology Group. Intraperitoneal cisplatin and paclitaxel in ovarian cancer. N Engl J Med. 2006 Jan 5;354(1):34-43. doi: 10.1056/NEJMoa052985. PubMed 16394300 ↗
  • Classe JM, Meeus P, Hudry D, Wernert R, Quenet F, Marchal F, Houvenaeghel G, Bats AS, Lecuru F, Ferron G, Brigand C, Berton D, Gladieff L, Joly F, Ray-Coquard I, Durand-Fontanier S, Liberale G, Pocard M, Georgeac C, Gouy S, Guilloit JM, Guyon F, Costan C, Rousselet JM, de Guerke L, Bakrin N, Brument E, Martin E, Asselain B, Campion L, Glehen O; UNICANCER/CHIPOR Investigators. Hyperthermic intraperitoneal chemotherapy for recurrent ovarian cancer (CHIPOR): a randomised, open-label, phase 3 trial. Lancet Oncol. 2024 Dec;25(12):1551-1562. doi: 10.1016/S1470-2045(24)00531-X. Epub 2024 Nov 14. PubMed 39549720 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 20, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01376752
Lead sponsor
UNICANCER
Responsible party
Sponsor
First posted
Jun 20, 2011
Start date
Apr 26, 2011
Primary completion
Jan 8, 2023
Completion
May 14, 2027 (estimated)
Last update
May 20, 2026

Study contacts

Jean-Marc CLASSE
principal investigator · Centre rené Gauducheau, NANTES

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.

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