- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03842982
Hyperthermic Intraperitoneal Chemotherapy (HIPEC) in Ovarian Cancer (CHIPPI) (CHIPPI)
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)
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Anticipated)
Phase
- Phase 3
Contacts and Locations
Study Contact
- Name: Marie VANSEYMORTIER
- Phone Number: +33 3 20 29 59 18
- Email: promotion@o-lambret.fr
Study Contact Backup
- Name: Fabrice MULOT
- Phone Number: +33 3 20 29 59 18
- Email: promotion@o-lambret.fr
Study Locations
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Bruxelles, Belgium, 1200
- Recruiting
- Cliniques universitaires St-Luc, Institut Roi Albert II
-
Contact:
- Florence FONTAINE
- Phone Number: +32 02 764 85 09
- Email: florence.fontaine@uclouvain.be
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Contact:
- Karoline AMANN
- Email: karoline.amann@uclouvain.be
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-
-
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Angers, France, 49055
- Recruiting
- Institut de Cancérologie de l'Ouest
-
Contact:
- Romuald WERNERT, MD
- Email: romuald.wernert@ico.unicancer.fr
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Principal Investigator:
- Romuald WERNERT, MD
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Sub-Investigator:
- Pedro RARO, MD
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Sub-Investigator:
- Valeria DE FRANCO, MD
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Sub-Investigator:
- Augustin REYNARD, MD
-
Sub-Investigator:
- Patrick SOULIE, MD
-
Sub-Investigator:
- Sophie ABADIE-LACOURTOISIE, MD
-
Sub-Investigator:
- Paule AUGEREAU, MD
-
Sub-Investigator:
- Anne PATSOURIS, MD
-
Sub-Investigator:
- Elouen BOUGHALEM, MD
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Sub-Investigator:
- Frederic BIGOT, MD
-
Sub-Investigator:
- Margot NOBLECOURT, MD
-
Sub-Investigator:
- Victor SIMMET, MD
-
Sub-Investigator:
- Marion DE VRIES, MD
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Bordeaux, France, 33076
- Not yet recruiting
- Institut Bergonie
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Contact:
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Caen, France, 14076
- Recruiting
- Centre Francois Baclesse
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Contact:
- Sandrine MARTIN-FRANCOISE, MD
- Email: marsa@baclessse.unicancer.fr
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Principal Investigator:
- Sandrine MARTIN-FRANCOISE, MD
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Sub-Investigator:
- Jean François LE BRUN, MD
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Sub-Investigator:
- Florence JOLY, MD
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Clermont-Ferrand, France, 63011
- Recruiting
- Centre Jean Perrin
-
Contact:
- Christophe POMEL, MD
- Email: christophe.pomel@clermont.unicancer.fr
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Principal Investigator:
- Christophe POMEL, MD
-
Sub-Investigator:
- Caroline CORNOU, MD
-
Sub-Investigator:
- Sophie DUBOIS, MD
-
Sub-Investigator:
- Morgane MASSON, MD
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Sub-Investigator:
- Marie-Ange MOURET-REYNIER, MD
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Lille, France, 59020
- Recruiting
- Centre Oscar Lambret
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Sub-Investigator:
- Delphine HUDRY, MD
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Contact:
- Fabrice NARDUCCI, MD
- Email: f-narducci@o-lambret.fr
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Principal Investigator:
- Fabrice NARDUCCI, MD
-
Sub-Investigator:
- Annick CHEVALIER-PLACE, MD
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Lille, France, 59037
- Recruiting
- Hôpital Jeanne de Flandre
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Contact:
- Pierre COLLINET, MD, PhD
- Email: pierre.collinet@chru-lille.fr
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Principal Investigator:
- Pierre COLLINET, MD, PhD
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Sub-Investigator:
- Clarisse EVENO, MD
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Sub-Investigator:
- Jérôme PHALIPPOU, MD
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Sub-Investigator:
- Christophe DESAUW, MD
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Sub-Investigator:
- Anne PLOQUIN, MD
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Marseille, France, 13273
- Recruiting
- Institut Paoli Calmettes
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Contact:
- Eric LAMBAUDIE, MD, PhD
- Email: lambaudiee@ipc.unicancer.fr
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Principal Investigator:
- Eric LAMBAUDIE, MD, PhD
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Sub-Investigator:
- Gilles HOUVENAEGHEL, MD
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Sub-Investigator:
- Guillaume BLACHE, MD
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Sub-Investigator:
- Laura SABIANI, MD
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Sub-Investigator:
- Julien BARROU, MD
-
Sub-Investigator:
- Maria Antonietta CAPPIELLO, MD
-
Sub-Investigator:
- Magali PROVANSAL, MD
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Sub-Investigator:
- Frédérique ROUSSEAU, MD
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Montpellier, France, 34298
- Recruiting
- ICM-Val d'Aurelle
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Contact:
- Pierre-Emmanuel COLOMBO, MD
- Email: Pierre-Emmanuel.Colombo@icm.unicancer.fr
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Sub-Investigator:
- Michel FABBRO, MD
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Paris, France, 75008
- Recruiting
- Hopital Europeen Georges Pompidou
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Contact:
- Anne-Sophie BATS, MD
- Email: anne-sophie.bats@aphp.fr
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Principal Investigator:
- Anne-Sophie BATS, MD
-
Sub-Investigator:
- Nicolas DELANOY, MD
-
Sub-Investigator:
- Henri AZAIS, MD
-
Sub-Investigator:
- Enrica BENTIVEGNA, MD
-
Sub-Investigator:
- Meriem KOUAL, MD
-
Sub-Investigator:
- Huyên-Thu NGUYEN-XUAN, MD
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Pierre-Bénite, France, 69495
- Recruiting
- Centre Hospitalier Lyon Sud
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Contact:
- Naoual BAKRIN, MD
- Email: naoual.bakrin@chu-lyon.fr
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Contact:
- Witold GERTYCH, MD
- Email: witold.gertych@chu-lyon.fr
-
Principal Investigator:
- Naoual BAKRIN, MD
-
Principal Investigator:
- Witold GERTYCH, MD
-
Sub-Investigator:
- Olivier GLEHEN, MD
-
Sub-Investigator:
- Vahan KEPENEKIAN, MD
-
Sub-Investigator:
- Pierre DESCARGUES, MD
-
Sub-Investigator:
- Pierre-Adrien BOLZE, MD
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Rouen, France, 76100
- Recruiting
- Clinique Mathilde
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Contact:
- Benoît RESCH, MD
- Email: benoit.resch@clinique-mathilde.fr
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Principal Investigator:
- Benoït RESCH, MD
-
Sub-Investigator:
- Marc BARON, MD
-
Sub-Investigator:
- Julien COGET, MD
-
Sub-Investigator:
- Clotilde HENNETIER, MD
-
Sub-Investigator:
- Morgane PERRIN, MD
-
Sub-Investigator:
- Jean Jacques TUECH, MD
-
Sub-Investigator:
- Alexandre MARQUE, MD
-
Sub-Investigator:
- Sandrine MEZZANI, MD
-
Sub-Investigator:
- Cécile HENNEBERT, MD
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Rouen, France
- Recruiting
- Centre Henri Becquerel
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Contact:
- Agathe CROUZET, MD
- Email: agathe.crouzet@chb.unicancer.fr
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Principal Investigator:
- Agathe CROUZET, MD
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Sub-Investigator:
- Julien CARRILHO, MD
-
Sub-Investigator:
- Albane POTEAU, MD
-
Sub-Investigator:
- Laetitia AUGUSTO, MD
-
Sub-Investigator:
- Sophie GOUERANT, MD
-
Sub-Investigator:
- Cécile GUILLEMET, MD
-
Sub-Investigator:
- Marianne LEHEURTEUR, MD
-
Sub-Investigator:
- Camille PETRAU, MD
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Saint-Herblain, France, 44800
- Withdrawn
- Institut de Cancérologie de l'Ouest
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Strasbourg, France
- Not yet recruiting
- Hopital de Hautepierre
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Contact:
- Chérif AKLADIOS, MD
- Email: Cherif.AKlADlOS@chru-strasbourg.fr
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Sub-Investigator:
- Thomas BOISRAME, MD
-
Principal Investigator:
- Chérif AKLADIOS, MD
-
Sub-Investigator:
- Lauriane EBERST, MD
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Vandœuvre-lès-Nancy, France, 54519
- Recruiting
- Institut de Cancerologie de Lorraine
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Contact:
- Frédéric MARCHAL, MD
- Email: f.marchal@nancy.unicancer.fr
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Principal Investigator:
- Frédéric Marchal, MD
-
Sub-Investigator:
- Yolanda FERNANDEZ DIEZ, MD
-
Sub-Investigator:
- Céline GAVOILLE, MD
-
Sub-Investigator:
- Marie-Christine KAMINSKY, MD
-
Sub-Investigator:
- Cécilia CERIBELLI, MD
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Villejuif, France, 94805
- Withdrawn
- Institut Gustave Roussy
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
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
- 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)
Exclusion Criteria:
- 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
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Arm A (PDS or IDS + HIPEC)
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. |
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:
Other Names:
|
No Intervention: Arm B (PDS or IDS)
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 the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall survival
Time Frame: From randomization to first progression, relapse or death from any cause , whichever came first, assessed up to 5 years..
|
The overall survival will be measured to assess the efficacy of HIPEC in combination with standard care.
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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.
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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.
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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
|
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.
|
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)
|
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.
|
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)
|
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.
|
Up to 2 years after the end of treatment (every 3 month)
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Fabrice NARDUCCI, MD, Centre Oscar Lambret, Lille, France
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Carcinoma
- Neoplasms, Glandular and Epithelial
- Genital Neoplasms, Female
- Wounds and Injuries
- Endocrine System Diseases
- Ovarian Diseases
- Adnexal Diseases
- Gonadal Disorders
- Endocrine Gland Neoplasms
- Body Temperature Changes
- Heat Stress Disorders
- Ovarian Neoplasms
- Carcinoma, Ovarian Epithelial
- Hyperthermia
- Fever
Other Study ID Numbers
- CHIPPI-1808
- 2018-003680-62 (EudraCT Number)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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