Short-course HIPEC in Advanced Epithelial Ovarian Cancer

This is an open-label, multicenter, single-arm, feasibility phase 2 trial on safety and efficacy of short-course regimen of intra-operative Hyperthermic Intraperitoneal Chemotherapy (HIPEC) at the time of fast-track interval debulking surgery (IDS) following neoadjuvant chemotherapy (NACT) for high tumor burden epithelial ovarian cancer (EOC).

Sex

All

Minimum age

18 Years

Maximum age

70 Years

* Inclusion Criteria:

  * Patients with no previous treatment and candidates for elective surgery with histological diagnosis of epithelial ovarian carcinoma;
  * Clinical stage IIIB to IV, without suspicion of extra-abdominal metastasis;
  * No other malignancies in activity;
  * No previous treatments such as radiation, chemotherapy (except neoadjuvant chemotherapy in the study protocol) or major abdominal surgery;
  * Absence of neuro-psychiatric disorders, history of drug allergies, and pregnancy or breast feeding;
  * Aged between 18 and 70 years;
  * Performance status 0-2 (ECOG, Eastern Cooperative Oncology Group) and / or greater than 70 points by the Karnofsky scale;
  * Appropriated cardio-respiratory, hepato-renal and hematological reserves;
  * Signing of the Consent Form.
* Exclusion Criteria:

  * Evidence of extensive retroperitoneal lymph node involvement or unresectable disease (i.e., massive involvement of the small bowel, mesentery, or hepatic pedicle, and ureteral or biliary obstruction) at the time of CRS/HIPEC;
  * Residual disease after the CRS greater than or equal to 2.5 mm (CC-2 and CC-3);
  * Limiting obesity for CRS or HIPEC;
  * Disease progression, apparent or confirmed uncontrolled infection, or health impairment during NACT.

• RESULTBatista TP, Carneiro VCG, Tancredi R, Teles ALB, Badiglian-Filho L, Leao CS. Neoadjuvant chemotherapy followed by fast-track cytoreductive surgery plus short-course hyperthermic intraperitoneal chemotherapy (HIPEC) in advanced ovarian cancer: preliminary results of a promising all-in-one approach. Cancer Manag Res. 2017 Dec 13;9:869-878. doi: 10.2147/CMAR.S153327. eCollection 2017. PMID 29263704
• RESULTBatista TP, Badiglian Filho L, Leao CS. Exploring flow rate selection in HIPEC procedures. Rev Col Bras Cir. 2016 Dec;43(6):476-479. doi: 10.1590/0100-69912016006014. English, Portuguese. PMID 28273222
• RESULTLustosa RJC, Batista TP, Carneiro VCG, Badiglian-Filho L, Costa RLR, Lopes A, Sarmento BJQ, Lima JTO, Mello MJG, LeAo CS. Quality of life in a phase 2 trial of short-course hyperthermic intraperitoneal chemotherapy (HIPEC) at interval debulking surgery for high tumor burden ovarian cancer. Rev Col Bras Cir. 2020;47:e20202534. doi: 10.1590/0100-6991e-20202534. Epub 2020 Jul 10. English, Portuguese. PMID 32667582