Short-course HIPEC in Advanced Epithelial Ovarian Cancer
Condition: Ovarian Cancer
MeSH terms: Ovarian Neoplasms; Carcinoma, Ovarian Epithelial
Study type: Interventional
Phase: Phase 2

Summary: 
      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).
    

Detailed description: 
      This study was initially designed to explore the safety and efficacy of short-course HIPEC in
      terms of median progression-free survival (PFS) as the primary outcome. However, due to slow
      accrual, the design was subsequently amended to explore the primary outcome measure of PD9
      (i.e.: proportion of patients with disease progression or death occurring within 9 months of
      IDS plus HIPEC). The hypothesis was the short-course HIPEC could decrease PD9 with low rates
      of morbidity and mortality. In these settings, we explore a comprehensive treatment approach
      involving fast-track advanced cytoreductive surgery (CRS) plus short-course HIPEC at the time
      of IDS following NACT for high tumor burden patients with stage III-IV ovarian cancer.
      Advanced CRS was performed with standard peritonectomy procedures and visceral resections
      directed towards complete elimination of tumors from the abdominopelvic cavity, and
      fast-track recovery strategies were also applied to improve patient outcomes. HIPEC was
      performed according to the closed-abdomen technique using CDDP (25 mg/L of perfusate/m2,
      total limit of 240mg) or CDDP plus Doxorubicin (15mg/L) for 30 minutes, with an
      intra-abdominal target temperature of 41-43°C. Perfusate (2L/m2, ranging from 4L to 6L) was
      circulated using an extracorporeal circulation device (Performer HT; RAND, Medolla, Italy) at
      a flow rate of 700 ml/min. Systemic chemotherapy included the standard combination of
      carboplatin and paclitaxel as neo-adjuvant plus adjuvant regimens.
    

Intervention name(s): Cytoreductive Surgery (CRS); Hyperthermic Intraperitoneal Chemotherapy (HIPEC); Neoadjuvant Chemotherapy (NACT); Adjuvant Chemotherapy; Fast-track recovery strategy
Intervention type(s): Procedure; Procedure; Drug; Drug; Procedure
Intervention description(s): CRS was performed with standard peritonectomy procedures and visceral resections directed towards complete elimination of tumors from the abdominopelvic cavity.; HIPEC was performed according to the closed-abdomen technique using CDDP (25 mg/L of perfusate/m2, total limit of 240mg) for the first 10 patients and thus, using CDDP plus Doxorubicin (15mg/L) thereafter, both for 30 minutes, with an intra-abdominal target temperature of 41-43°C. Perfusate (2L/m2, ranging from 4L to 6L) was circulated using an extracorporeal circulation device (Performer HT; RAND, Medolla, Italy) at a flow rate of 700 ml/min.; Systemic chemotherapy included the standard combination of carboplatin (AUC 6) and paclitaxel (175 mg/m2) administered every 21 days as neoadjuvant (2-4 cycles) plus adjuvant regimens (2-4 cycles), in the total of 6 cycles of systemic chemotherapy.; Systemic chemotherapy included the standard combination of carboplatin (AUC 6) and paclitaxel (175 mg/m2) administered every 21 days as neoadjuvant (2-4 cycles) plus adjuvant regimens (2-4 cycles), in the total of 6 cycles of systemic chemotherapy.; A comprehensive fast-track program was applied to accelerate recovery, reduce morbidity, and shorten convalescence for patients enrolled in our trial.
Other intervention name(s): Carboplatin; Paclitaxel; Carboplatin; Paclitaxel
Intervention MeSH terms: Paclitaxel; Albumin-Bound Paclitaxel; Carboplatin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Ovarian Cancer