Ovary NeoplasmsPhase 3CHIPPINCT03842982
Hyperthermic Intraperitoneal Chemotherapy (HIPEC) in Ovarian Cancer (CHIPPI)
A Phase 3 study testing HIPEC in people with Ovary Neoplasms and Ovarian Cancer, run by Centre Oscar Lambret at 18 sites in 2 countries.
Trial summary
This is a phase III, multicenter, interventional and randomized study which evaluates the use of Hyperthermic Intraperitoneal Chemotherapy (HIPEC) coupled with either Primary Debulking Surgery (PDS) or Interval Debulking Surgery (IDS), in patients with ovarian cancer. Read more about this study
- Who is it for?
- Ages 18 to 76 years, women only
- Conditions the study is for
- Ovary Neoplasms, Ovarian Cancer, Ovarian Carcinoma
- What is being tested?
- HIPEC
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 362 participants
- Where
- 18 sitesin 2 countries
- Study dates
- 3 May 2019to 1 Feb 2031
- 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 to 76 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pre-eligibility criteria to be checked before surgery for pre-registration
- Age ≥18 years and ≤ 76 years
- Histologically proven primary epithelial ovarian carcinoma or fallopian tube carcinoma or peritoneal carcinoma (including serous papillary adenocarcinoma, clear-cell carcinoma, mucinous adenocarcinoma and endometrioid carcinoma)
- Pre-therapeutic FIGO (International Federation of Gynecology and Obstetrics) stage III
- Patient eligible for
- Primary Debulking Surgery (PDS) with planned adjuvant chemotherapy +/- bevacizumab or other targeted therapy
Show all 24Show fewer
- Or Interval Debulking Surgery (IDS) after neo-adjuvant chemotherapy +/- bevacizumab or other targeted therapy, with or without planned adjuvant chemotherapy +/- bevacizumab or other targeted therapy. In case of neo-adjuvant chemotherapy, surgery should be performed in a time interval of 3 to 5 weeks in case of chemotherapy without bevacizumab, and in a time interval of 4 to 6 weeks if chemotherapy is combined with bevacizumab. The patient remains eligible for the study if surgery is delayed beyond the recommended time interval.
- WHO (World Health Organization Performance Status) ≤ 2
- Physical status score ASA (American Society of Anesthesiologists) ≤ 2
- Adequate bone marrow and renal function, as evidenced by the following tests performed within 7 days prior to surgery:
- Absolute Neutrophil Count (ANC) ≥1,500/mm3
- Platelets ≥100,000/mm3
- Aspartate aminotransferase (ALT)/ Alanine aminotransferase (ALT) ≤2.5 × upper limit of normal (ULN) (≤5.0 × ULN in case of liver metastases)
- Total bilirubin ≤1.5 × ULN (except in case of Gilbert's disease)
- Creatinine clearance ≥ 60 mL/ min
- Negative serum pregnancy test within 7 days prior to surgery for women of childbearing potential. For non-menopausal women, if no hysterectomy is planned, willing to accept the use of an effective contraceptive regimen during the treatment period and at least 6 months after the end of treatment (surgery or adjuvant chemotherapy)
- Absence of contraindication to receive the products used in this study (cisplatin and products used in neo-adjuvant/ adjuvant chemotherapy) according to the most recent SmPC (Summary of Product Characteristics) of these products
- Patient is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow-up
- Signed written informed consent
- Patient covered by the French or Belgian "Social Security" regime Criteria to be checked per-operatively for confirmation of enrolment and randomization
- Residual disease after surgery (cytoreduction score CC) CC-0 (no macroscopic residue) or CC-1 (residue < 2.5 mm)
- Per-operative hemorrhage < 2.5 L
- Strictly less than 3 digestive resections performed during surgery
- Diuresis maintained during surgery, without oliguria or anuria (per-operatory diuresis ≥ 0,5 mL/ kg/ h)
Who cannot join
- Benign disease, borderline disease, non epithelial ovarian carcinoma or carcinosarcoma
- Cirrhosis
- Known hypersensitivity to any of the study drugs, study drug classes, or excipients in the formulation
- Auditory impairment
- Dehydration or intercurrent disease that contraindicates hyperhydration (including cardio-respiratory disease)
- Other uncontrolled intercurrent disease including, but not limited to: diabetes; hypertension; symptomatic congestive heart or pulmonary failure; renal, hepatic or severe gastrointestinal (associated with diarrhea) chronic disease
Show all 13Show fewer
- Any unresolved NCI-CTCAE Grade ≥ 2 toxicity from previous anticancer therapy (excluding alopecia)
- Concomitant treatment with prophylactic phenytoin
- Receipt of live attenuated vaccine, including yellow fever vaccine, within 30 days prior to inclusion (and, if patient is enrolled, up to 30 days after the last administration of study treatment)
- Pregnant or breastfeeding woman
- Psychiatric illness or social situation that would limit compliance with study requirement, substantially increase the risk of side effects, or compromise the ability of the patient to give written informed consent
- Inability to comply with medical follow-up of the trial (geographical, social or psychic reasons)
- Person under guardianship
Trial locations and contacts
18 sites in 2 countries.
18 sites in 2 countries
France16 sites
Institut de Cancérologie de l'Ouest
Angers, 49055
Institut Bergonié
Bordeaux, 33076
Centre François Baclesse
Caen, 14076
Centre Jean Perrin
Clermont-Ferrand, 63011
Centre Oscar Lambret
Lille, 59020
Hôpital Jeanne de Flandre
Lille, 59037
Institut Paoli Calmettes
Marseille, 13273
ICM-Val d'Aurelle
Montpellier, 34298
Hôpital Européen Georges Pompidou
Paris, 75008
Centre Hospitalier Lyon Sud
Pierre-Bénite, 69495
Clinique Mathilde
Rouen, 76100
Centre Henri Becquerel
Rouen
Institut de Cancérologie de l'Ouest
Saint-Herblain, 44800
Hôpital de Hautepierre
Strasbourg
Institut de Cancérologie de Lorraine
Vandœuvre-lès-Nancy, 54519
Institut Gustave Roussy
Villejuif, 94805
Belgium2 sites
Institut Jules Bordet
Brussels, 1070
Cliniques universitaires St-Luc, Institut Roi Albert II
Brussels, 1200
About this study
Official title: Phase III Randomized Clinical Trial Evaluating Hyperthermic Intraperitoneal Chemotherapy (HIPEC) in Ovarian Cancer Considering Two Different Settings: Primary Debulking Surgery (PDS) and Interval Debulking Surgery (IDS)
This is a phase III, multicenter, interventional and randomized study which evaluates the use of Hyperthermic Intraperitoneal Chemotherapy (HIPEC) coupled with either Primary Debulking Surgery (PDS) or Interval Debulking Surgery (IDS), in patients with ovarian cancer. This study aims to assess the efficacy, in terms of disease-free survival (DFS), the use of HIPEC combined with standard care (PDS or IDS) or standard care alone.
Read the detailed description
The primary objective of this study is to assess the efficacy, in terms of disease-free survival (DFS), the use of HIPEC treatment combined with standard care (PDS or IDS) or standard care alone (PDS or IDS alone).
Secondary objectives of the study include:
- Evaluating the efficacy of HIPEC in terms of overall survival (OS) in combination with standard of care
- Evaluating the morbidity associated with HIPEC.
- Evaluating the trade-off between efficacy and morbidity using the Q-TWiST approach.
- Evaluating the impact of HIPEC in terms of quality of life.
Exploratory objectives (optional) include:
- Evaluating the impact of HIPEC on the count of residual viable cells (evaluated by flow cytometry) in abdominal drainage fluids for patients recruited in Centre Oscar Lambret only.
- Constituting a biobank (tumoral samples and blood samples) for future translational researches
- Conditions
- Ovary Neoplasms, Ovarian Cancer, Ovarian Carcinoma
- Being tested
- HIPEC
- Keywords
- Ovarian cancer, Hyperthermic intraperitoneal chemotherapy, HIPEC, Primary Debulking Surgery, Interval Debulking Surgery
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HIPECDrug
Also called Hyperthermic intraperitoneal chemotherapy
HIPEC protocol (ONLY Arm A) consisted in cisplatin 100mg/m2 intraperitoneally (IP), heated to 40°C for 90 minutes, along with an IV perfusion of sodium thiosulfate.
Administration of the dose should be according the following schedule:
- 50% of the dose at start of perfusion, 25% of the dose after 30 minutes from start of the perfusion and 25% of the dose after 60 minutes from start of the perfusion.
- The procedure takes 120 minutes with a 90-minute perfusion period. The IV perfusion of sodium thiosulfate is for renal protection. At the start of HIPEC procedure, 9 g/m2 in 200 ml of distilled water will be administered by IV over 15 to 30 minutes. It will be then followed by 12 g/m2 in 1 liter (1L) distilled water in a continuous IV for 6 hours.
| Study group | Role | What they receive |
|---|---|---|
| Arm A (PDS or IDS + HIPEC) | Experimental | Surgery (Primary Debulking Surgery (PDS) or Interval Debulking Surgery (IDS)) + Neo or Adjuvant chemotherapy (standard care) + HIPEC (hyperthermic intraperitoneal chemotherapy)
Patients in this experimental arm will receive surgery (either PDS or IDS) and Neo and/or Adjuvant chemotherapy (CT) (as per standard care) combined with HIPEC. Patients undergoing PDS will also be receiving 6 cycles adjuvant CT according to the standard care (ideally 6 weeks post-surgery).
Patient undergoing IDS will start with 6 cycles of neo-adjuvant CT with a 3 - 5 weeks washout period (4 - 6 weeks if administered Bevacizumab) prior to surgery. They may also undergo additional adjuvant CT post-surgery according to the standard care. Receives: Drug: HIPEC |
| Arm B (PDS or IDS) | No intervention | Surgery (Primary Debulking Surgery (PDS) or Interval Debulking Surgery (IDS)) + Neo or Adjuvant chemotherapy ONLY (standard care, without HIPEC) Patients in the control group will ONLY receive the standard care, which consists of surgery (PDS or IDS) with Neo and/or Adjuvant chemotherapy (CT). Patients undergoing PDS will be receiving 6 cycles adjuvant CT according to the standard care (ideally 6 weeks post-surgery). Patient undergoing IDS will start with 6 cycles of neo-adjuvant CT with a 3 - 5 weeks washout period (4 - 6 weeks if administered Bevacizumab) prior to surgery. They may also undergo additional adjuvant CT post-surgery according to the standard care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease-free Survival (DFS)
The DFS will be measured to assess the efficacy of the combination treatment of surgery and HIPEC or standard care alone.
Measured: From randomization to first progression, relapse or death from any cause, whichever came first, assessed up to 5 years. (Follow-up up to 5 years)
Secondary outcomes (5)
Overall survival
The overall survival will be measured to assess the efficacy of HIPEC in combination with standard care.
Measured: From randomization to first progression, relapse or death from any cause , whichever came first, assessed up to 5 years..
Adverse events (AE)
The adverse events (AE) are collected to evaluate the impact of HIPEC on the safety and on the feasibility of adjuvant treatment (if any) is planned after surgery.
Measured: Covers the whole treatment duration from Randomization up to the end of treatment (surgery or CT) plus 30 days.
Q-TWiST
Q-Twist (Quality-adjusted time without symptoms of disease or toxicity) will be calculated from the survival tile (OS and DFS) and AE (adverse events) data.
Measured: Over the 5 year surveillance period
Quality of life of the patient (QLQC30)
European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Score 30 (QLQ-C30) will be used to measure the quality of life of the patients.
Measured: Up to 2 years after the end of treatment (every 3 month)
Quality of life of the patient (QLQOV28)
European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Ovarian Cancer Module (QLQ-OV28) will be used to measure the quality of life of the patients.
Measured: Up to 2 years after the end of treatment (every 3 month)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2019
- Study start3 May 2019
- Primary completion1 Feb 2031 (estimated)
- Study completion1 Feb 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovary NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 362 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Oscar Lambret
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fabrice NARDUCCI, MD, Study director, Centre Oscar Lambret, Lille, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03842982
- Sponsor's protocol ID
- CHIPPI-1808
- Other IDs
- 2024-514706-31-01, 2018-003680-62, 2018
- Acronym
- CHIPPI
- Status last verified
- Mar 2026
- First submitted
- 13 Feb 2019
- Last updated
- 16 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase III Randomized Clinical Trial Evaluating Hyperthermic Intraperitoneal Chemotherapy (HIPEC) in Ovarian Cancer Considering Two Different Settings: Primary Debulking Surgery (PDS) and Interval Debulking Surgery (IDS)
- ClinicalTrials.gov ID
- NCT03842982
- Acronym / sponsor ID
- CHIPPI / CHIPPI-1808
- Conditions
- Ovary Neoplasms, Ovarian Cancer, Ovarian Carcinoma
- Keywords
- Ovarian cancer, Hyperthermic intraperitoneal chemotherapy, HIPEC, Primary Debulking Surgery, Interval Debulking Surgery
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 362 participants (estimated)
- Lead sponsor
- Centre Oscar LambretUniversity, hospital or other
- Study start
- 3 May 2019 (actual)
- Primary completion
- 1 Feb 2031 (estimated)
- Study completion
- 1 Feb 2031 (estimated)
- First posted
- 15 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a phase III, multicenter, interventional and randomized study which evaluates the use of Hyperthermic Intraperitoneal Chemotherapy (HIPEC) coupled with either Primary Debulking Surgery (PDS) or Interval Debulking Surgery (IDS), in patients with ovarian cancer. This study aims to assess the efficacy, in terms of disease-free survival (DFS), the use of HIPEC combined with standard care (PDS or IDS) or standard care alone.
Detailed description
The primary objective of this study is to assess the efficacy, in terms of disease-free survival (DFS), the use of HIPEC treatment combined with standard care (PDS or IDS) or standard care alone (PDS or IDS alone).
Secondary objectives of the study include:
- Evaluating the efficacy of HIPEC in terms of overall survival (OS) in combination with standard of care
- Evaluating the morbidity associated with HIPEC.
- Evaluating the trade-off between efficacy and morbidity using the Q-TWiST approach.
- Evaluating the impact of HIPEC in terms of quality of life.
Exploratory objectives (optional) include:
- Evaluating the impact of HIPEC on the count of residual viable cells (evaluated by flow cytometry) in abdominal drainage fluids for patients recruited in Centre Oscar Lambret only.
- Constituting a biobank (tumoral samples and blood samples) for future translational researches
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A (PDS or IDS + HIPEC) | Experimental | Drug: HIPECSurgery (Primary Debulking Surgery (PDS) or Interval Debulking Surgery (IDS)) + Neo or Adjuvant chemotherapy (standard care) + HIPEC (hyperthermic intraperitoneal chemotherapy) Patients in this experimental arm will receive surgery (either PDS or IDS) and Neo and/or Adjuvant chemotherapy (CT) (as per standard care) combined with HIPEC. Patients undergoing PDS will also be receiving 6 cycles adjuvant CT according to the standard care (ideally 6 weeks post-surgery). Patient undergoing IDS will start with 6 cycles of neo-adjuvant CT with a 3 - 5 weeks washout period (4 - 6 weeks if administered Bevacizumab) prior to surgery. They may also undergo additional adjuvant CT post-surgery according to the standard care. |
| Arm B (PDS or IDS) | No intervention | –Surgery (Primary Debulking Surgery (PDS) or Interval Debulking Surgery (IDS)) + Neo or Adjuvant chemotherapy ONLY (standard care, without HIPEC) Patients in the control group will ONLY receive the standard care, which consists of surgery (PDS or IDS) with Neo and/or Adjuvant chemotherapy (CT). Patients undergoing PDS will be receiving 6 cycles adjuvant CT according to the standard care (ideally 6 weeks post-surgery). Patient undergoing IDS will start with 6 cycles of neo-adjuvant CT with a 3 - 5 weeks washout period (4 - 6 weeks if administered Bevacizumab) prior to surgery. They may also undergo additional adjuvant CT post-surgery according to the standard care. |
Who may qualify
- Ages
- 18 to 76 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (24 listed)
- Pre-eligibility criteria to be checked before surgery for pre-registration
- Age ≥18 years and ≤ 76 years
- Histologically proven primary epithelial ovarian carcinoma or fallopian tube carcinoma or peritoneal carcinoma (including serous papillary adenocarcinoma, clear-cell carcinoma, mucinous adenocarcinoma and endometrioid carcinoma)
- Pre-therapeutic FIGO (International Federation of Gynecology and Obstetrics) stage III
- Patient eligible for
Key exclusion criteria (13 listed)
- Benign disease, borderline disease, non epithelial ovarian carcinoma or carcinosarcoma
- Cirrhosis
- Known hypersensitivity to any of the study drugs, study drug classes, or excipients in the formulation
- Auditory impairment
- Dehydration or intercurrent disease that contraindicates hyperhydration (including cardio-respiratory disease)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HIPECAlso: Hyperthermic intraperitoneal chemotherapyHIPEC protocol (ONLY Arm A) consisted in cisplatin 100mg/m2 intraperitoneally (IP), heated to 40°C for 90 minutes, along with an IV perfusion of sodium thiosulfate. Administration of the dose should be according the following schedule: * 50% of the dose at start of perfusion, 25% of the dose after 30 minutes from start of the perfusion and 25% of the dose after 60 minutes from start of the perfusion. * The procedure takes 120 minutes with a 90-minute perfusion period. The IV perfusion of sodium thiosulfate is for renal protection. At the start of HIPEC procedure, 9 g/m2 in 200 ml of distilled water will be administered by IV over 15 to 30 minutes. It will be then followed by 12 g/m2 in 1 liter (1L) distilled water in a continuous IV for 6 hours. | Drug | Arm A (PDS or IDS + HIPEC) |
Primary outcome
Disease-free Survival (DFS)
Time frame: From randomization to first progression, relapse or death from any cause, whichever came first, assessed up to 5 years. (Follow-up up to 5 years)
The DFS will be measured to assess the efficacy of the combination treatment of surgery and HIPEC or standard care alone.
5 secondary outcomes
Overall survival
Time frame: From randomization to first progression, relapse or death from any cause , whichever came first, assessed up to 5 years..
Adverse events (AE)
Time frame: Covers the whole treatment duration from Randomization up to the end of treatment (surgery or CT) plus 30 days.
Q-TWiST
Time frame: Over the 5 year surveillance period
Quality of life of the patient (QLQC30)
Time frame: Up to 2 years after the end of treatment (every 3 month)
Quality of life of the patient (QLQOV28)
Time frame: Up to 2 years after the end of treatment (every 3 month)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2026.
- Individual participant dataSharing planned: No
Related trials for Ovary Neoplasms
Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
Recruiting
A Study to Compare Two Surgical Procedures in Individuals With BRCA1 Mutations to Assess Reduced Risk of Ovarian Cancer
Ovarian Carcinoma
RecruitingPhase 2
Investigation of Ubamatamab Combination Therapy in Adult Participants With Platinum-Resistant Ovarian Cancer
Ovarian Cancer, Fallopian Tube Cancer
Recruiting
The Vanguard Study: Testing a New Way to Screen for Cancer
Bladder Carcinoma, Breast Carcinoma
RecruitingPhase 3
Torvutatug Samrotecan Plus Bevacizumab as First-line Maintenance in Non-Homologous Recombination Deficiency (Non-HRD) Positive Advanced Epithelial Ovarian Cancer
Epithelial Ovarian Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fabrice NARDUCCI, MD study director
Centre Oscar Lambret, Lille, France
18 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing HIPEC in people with Ovary Neoplasms and Ovarian Cancer, run by Centre Oscar Lambret at 18 sites in 2 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 24 inclusion and 13 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 16 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in France, Belgium. 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?
Disease-free Survival (DFS) (time frame: From randomization to first progression, relapse or death from any cause, whichever came first, assessed up to 5 years. (Follow-up up to 5 years)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Mar 2026.