Hyperthermic Intraperitoneal Chemotherapy (HIPEC) in Ovarian Cancer (CHIPPI)

  • STATUS
    Recruiting
  • End date
    Aug 1, 2028
  • participants needed
    362
  • sponsor
    Centre Oscar Lambret
Updated on 3 November 2021
mucinous adenocarcinoma
renal function
cancer
hysterectomy
carcinoma
residual tumor
metastasis
neutrophil count
liver metastasis
bevacizumab
cancer chemotherapy
adenocarcinoma
targeted therapy
ovarian cancer
fallopian tube
immunostimulant
endometrioid carcinoma
ovarian carcinoma
peritoneal carcinoma
tumor debulking
intraperitoneal chemotherapy
cytoreduction
ovarian epithelial carcinoma
cancer of the ovary
primary debulking surgery
interval debulking surgery

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. 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.

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

Details
Condition Ovarian disorder, Ovarian Cancer, Ovarian Function, Epithelial Ovarian Carcinoma, Recurrent Ovarian Cancer, ovarian carcinoma, ovarian epithelial carcinoma, carcinoma of the ovary, ovarian carcinomas, cancer, ovarian, cancer ovarian, cancer of the ovary, ovarian tumors
Treatment HIPEC
Clinical Study IdentifierNCT03842982
SponsorCentre Oscar Lambret
Last Modified on3 November 2021

Eligibility

Yes No Not Sure

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
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