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Ovarian Epithelial Cancer RecurrentPhase 3CHIPORNCT01376752

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

A Phase 3 study testing Maximal cytoreductive surgery and HIPEC in people with Ovarian Epithelial Cancer Recurrent, run by UNICANCER at 33 sites in 3 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Ovarian Epithelial Cancer Recurrent
What is being tested?
Maximal cytoreductive surgery and HIPEC
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
415 participants
Where
33 sitesin 3 countries
Study dates
26 Apr 2011to 14 May 2027
Phase
Phase 3
Are there results?
Not yet: the study is under way

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 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 13Show fewer
  • 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

Who cannot join

  • 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
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  • 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

Trial locations and contacts

33 sites in 3 countries.

33 sites in 3 countries

France31 sites

  • CHU d'AMIENS

    Amiens

  • Centre Paul Papin

    Angers, 49933

  • Institut Bergonie

    Bordeaux, 33076

  • Clinique Pasteur

    Brest

  • Polyclinique Kéraudren

    Brest

  • Centre Francois Baclesse

    Caen, 14076

  • Centre Jean Perrin

    Clermont-Ferrand, 63011

  • Centre hospitalier de Dijon

    Dijon

  • CHU de Grenoble

    Grenoble

  • Clinique Victor Hugo

    Le Mans

  • Pôle Santé Sud

    Le Mans

  • Centre Oscar Lambret

    Lille, 59020

  • CHU de Lille

    Lille

  • Centre Hospitalier Universitaire Dupuytren

    Limoges, 87042

  • Centre Leon Berard

    Lyon, 69373

  • Centre Hopsitalier Lyon Sud

    Lyon, 69495

  • Institut Paoli Calmettes

    Marseille, 13273

  • AP-HM - Hôpital de la Timone

    Marseille

  • CRLC Val d'Aurelle

    Montpellier, 34298

  • Centre Hospitalier Universitaire Nice

    Nice, 06202

  • Hopital Lariboisiere

    Paris, 75010

  • Hopital Tenon

    Paris, 75020

  • Hôpital Européen Georges Pompidou

    Paris

  • Institut Curie

    Paris

  • CHU - Hôpital de la Milétrie

    Poitiers

  • Centre Hospitalier Universitaire Saint Etienne- Hopital Nord

    Saint-Etienne, 42055

  • Ico-Centre Rene Gauducheau

    Saint-Herblain, 44805

  • CHU Hautepierre

    Strasbourg, 67098

  • Institut Claudius Regaud

    Toulouse, 31052

  • Centre Alexis Vautrin

    Vandœuvre-lès-Nancy, 54511

  • Institut Gustave Roussy

    Villejuif, 94805

Other trials in France

Belgium1 site

  • Institut Jules Bordet

    Brussels

Other trials in Belgium

Spain1 site

  • Hospital Universitari Germans Trias I Pujol

    Badalona

Other trials in Spain

About this study

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

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.

Being tested
Maximal cytoreductive surgery, HIPEC

What participants receive

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

  • Maximal cytoreductive surgeryProcedure or surgery

    Maximal cytoreductive surgery

  • HIPECDrug

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

Study groups in NCT01376752
Study groupRoleWhat they receive
maximal cytoreductive surgery without HIPECActive comparatorThe participant will have a regular cytoreductive surgery without the adjunction of HIPEC.
Receives: Procedure: Maximal cytoreductive surgery
maximal cytoreductive surgery with HIPECExperimentalThe participant will have a regular cytoreductive surgery, then the adjunction of HIPEC: hyperthermic cisplatin will be used at 75mg/m²
Receives: Procedure: Maximal cytoreductive surgery; Drug: HIPEC

What is being measured

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

  1. overall survival

    Follow-up of 4 years.

    Measured: from randomization to death (up to 4 years)

Secondary outcomes (1)

  1. relapse free survival

    Follow-up of 4 years.

    Measured: from randomization to relapse (up to 4 years)

Timeline

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

  1. First posted20 Jun 2011 (estimated)
  2. Study start26 Apr 2011
  3. Primary completion8 Jan 2023
  4. Study completion14 May 2027 (estimated)

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
415 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01376752
Sponsor's protocol ID
FEDEGYN 02 / 0410-CHIPOR
Other IDs
2010-023035-42
Acronym
CHIPOR
Status last verified
Apr 2026
First submitted
28 Mar 2011
Last updated
20 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

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

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Maximal cytoreductive surgery and HIPEC in people with Ovarian Epithelial Cancer Recurrent, run by UNICANCER at 33 sites in 3 countries.

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 13 inclusion and 16 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: under way, not looking for participants, as of the sponsor's last update on 20 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 33 sites in France, Belgium, Spain. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

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?

overall survival (time frame: from randomization to death (up to 4 years)). 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 NCT01376752, which also lists 3 linked publications.

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 20 May 2026; AzTrials last refreshed its copy on 26 Oct 2026.

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