scholarly journals Clinical Trial Protocol for HyNOVA: Hyperthermic and Normothermic intraperitoneal chemotherapy following interval cytoreductive surgery for stage III epithelial OVArian, fallopian tube and primary peritoneal cancer (ANZGOG1901/2020)

2022 ◽  
Vol 33 ◽  
Author(s):  
Rhonda Farrell ◽  
Michael Burling ◽  
Yeh Chen Lee ◽  
Selvan Pather ◽  
Kristy Robledo ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Fallopian Tube ◽  
Intraperitoneal Chemotherapy ◽  
Cytoreductive Surgery ◽  
Stage Iii ◽  
Trial Protocol ◽  
Primary Peritoneal Cancer ◽  
Clinical Trial Protocol ◽  
Peritoneal Cancer

scholarly journals Morbidity after cytoreductive surgery and hyperthermic intraperitoneal chemotherapy with carboplatin used for ovarian, tubal, and primary peritoneal cancer

2019 ◽  
Vol 120 (3) ◽  
pp. 550-557 ◽  
Author(s):  
Mette Schou Mikkelsen ◽  
Thora Christiansen ◽  
Lone Kjeld Petersen ◽  
Jan Blaakaer ◽  
Lene Hjerrild Iversen
Keyword(s):  
Intraperitoneal Chemotherapy ◽  
Cytoreductive Surgery ◽  
Hyperthermic Intraperitoneal Chemotherapy ◽  
Primary Peritoneal Cancer ◽  
Peritoneal Cancer

Primary cytoreductive surgery with or without Hyperthermic Intraperitoneal Chemotherapy (HIPEC) for FIGO stage III epithelial ovarian cancer: The OVHIPEC-2 trial in progress.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. TPS6100-TPS6100
Author(s):  
Ruby M. van Stein ◽  
Simone N. Koole ◽  
Karolina Sikorska ◽  
Desmond P. Barton ◽  
Lewis Perrin ◽  
...  
Keyword(s):  
Ovarian Cancer ◽  
Overall Survival ◽  
Intraperitoneal Chemotherapy ◽  
Cytoreductive Surgery ◽  
Hyperthermic Intraperitoneal Chemotherapy ◽  
Figo Stage ◽  
Phase Iii ◽  
Stage Iii ◽  
Peritoneal Cancer ◽  
Anticancer Treatment

TPS6100 Background: The addition of Hyperthermic Intraperitoneal Chemotherapy (HIPEC) to interval cytoreductive surgery improves recurrence-free and overall survival in patients with FIGO stage III ovarian cancer who are ineligible for primary cytoreductive surgery due to extensive intraperitoneal disease. The effect of HIPEC remains undetermined in patients who are eligible for primary cytoreductive surgery. We hypothesize that the addition of HIPEC to a complete or near-complete (residual disease ≤2.5 mm) primary cytoreductive surgery improves overall survival in patients with FIGO stage III ovarian cancer. Methods: This international, randomized, open-label, phase III trial enrolls patients with newly diagnosed, histological proven FIGO stage III epithelial ovarian, fallopian tube, or primary peritoneal cancer. Patients with resectable umbilical, spleen or local bowel lesions may be included. Following complete or near-complete primary cytoreduction, patients are intra-operatively randomized (1:1) to receive HIPEC or no HIPEC. Patients in both study arms will receive six courses of adjuvant carboplatin-paclitaxel and maintenance PARP-inhibitor or bevacizumab according to current guidelines. The primary endpoint is overall survival. To detect a Hazard Ratio of 0.67 in favor of HIPEC, 200 overall survival events are required. Assuming that accrual will be completed in 60 months, and 12 months additional follow-up, 538 patients need to be randomized. All randomized patients will be included in the analysis for overall survival according to the intention to treat principle. Pre-specified subgroup analyses will be performed based on stratification factors (peritoneal cancer index at start of surgery, completeness of surgery), histologic subtype (high-grade serous versus other), and BRCA mutation (BRCA1/2 mutation versus wildtype). Secondary endpoints are recurrence-free survival, time to first subsequent anticancer treatment, and treatment related complications and toxicity. Exploratory endpoints are time to second subsequent anticancer treatment, health-related quality of life, and cost-effectiveness. The Institutional Review Board of the Netherlands Cancer Institute approved the trial, which is actively enrolling patients since January 2020. Clinical trial information: NCT03772028.

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