Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) Associated With Systemic Chemotherapy in Women With Advanced Ovarian Cancer

Launched by HOSPICES CIVILS DE LYON · Mar 19, 2021

Keywords

ClinConnect Summary

This clinical trial is studying a new approach to treat advanced ovarian cancer in women who have not responded well to previous chemotherapy. The treatment combines a special type of chemotherapy called Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) with standard chemotherapy (carboplatin and paclitaxel). The main goal is to find the highest dose of PIPAC that can be safely given to patients. Women aged 18 to 75 who have specific types of ovarian or fallopian tube cancer and have not had a good response to earlier treatments may be eligible to participate.

Participants in the trial will receive three cycles of the combined chemotherapy over a 12-week period. They will be closely monitored for any side effects and their tumor response will be evaluated through imaging tests at the end of the treatment. If their cancer improves and becomes resectable (able to be surgically removed), they may undergo surgery. This trial also aims to gather information about how the body processes the chemotherapy drugs and to assess the overall safety of the treatment. It's an important study that hopes to improve treatment options for women facing advanced stages of ovarian cancer.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • Age ≥18 years and ≤ 75 years
• • ECOG PS 0-2 ;
• • Epithelial stage IIb to IVa carcinoma of the ovary, fallopian tubes, or peritoneum proven histologically, stage III or IV of the FIGO classification and with history of insufficient tumor response/ after three cycles of previous neoadjuvant systemic carboplatin-paclitaxel chemotherapy as judged by the investigators after discussion and validation in Multidisciplinary Team ;
• • Adequate hematologic function
• • Absolute Neutrophil Count \> 1500 / mm3 (or 1.5 10 9/L)
• • Hemoglobin ≥ 9.0 g/dL,
• • platelets \> 100 G/L,
• * Adequate hepatic and renal function:
• • Serum creatinine ≤1.5 times upper normal values or glomerular filtration rate ≥ 60 mL/min/1.73 m2 estimated by the CKD-EPI equation
• • Total bilirubin ≤1.5 times the upper normal limit,
• • ASAT / ALAT ≤1.5 times the upper normal limit (≤5 times upper normal limits for patients with liver metastases);
• • Absence of unstable pathologies : myocardial infarction within 6 months prior to the start of the study, congestive heart failure, unstable angina, active cardiomyopathy, unstable rhythm disorder, uncontrolled hypertension, uncontrolled psychiatric disorders, severe infection, peptic ulcer, or any pathology that could be aggravated by treatment or limit compliance (investigator's judgment)
• • Patient information given and Written informed consent obtained prior to the initiation of any specific study procedure
• • Affiliated to a social insurance regime or similar
• Exclusion Criteria:
• • Extra-peritoneal metastases (position or number which make the disease unresectable)
• • Signs of intestinal obstruction or lesions with risk of intestinal perforation, or signs of inflammatory disease of the digestive tract
• • Contraindication to systemic chemotherapy CARBOPLATIN-PACLITAXEL :known allergy to paclitaxel
• * Contraindication to the PIPAC procedure:
• • Known allergy to cisplatin or other platinum-containing compounds
• • Known allergy to doxorubicin or other anthracyclines or anthracenediones;
• • Heart failure with myocardial insufficiency
• • Uncontrolled coronary insufficiency;
• • Pregnancy or breastfeeding
• • Persons deprived of liberty or under guardianship ;
• • Major patient protected by the Law;
• • Persons participating in other research with an exclusion period still in progress at the time of inclusion or research that may interfere with the results of the present study (investigator's judgment) ;
• • Impossibility to submit to the medical follow-up of the trial for geographical, social or psychic reasons (investigator's judgement)