drugset / Trial / NCT02249013
Short-course HIPEC in Advanced Epithelial Ovarian Cancer
Phase 2
Completed
15 enrolled
Professor Fernando Figueira Integral Medicine Institute
AC Camargo Cancer Center (São Paulo/SP) · collabHospital Sao Jose (Criciuma/SC) · collabHospital de Base do Distrito Federal (Brasilia/DF) · collabHospital de Cancer de Barretos - Fundacao Pio XII · collabHospital de Câncer de Pernambuco (Recife/PE) · collabInstituto Brasileiro de Controle do Câncer (São Paulo/SP) · collab
NaSingle-groupOpen-labelTreatment
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).
Timeline
- Start
- 2015-02
- Primary completion
- 2021-02-23
- Completion
- 2021-02-23
Publications
- Results Batista 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.
- Results Batista 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.
- Results Lustosa 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Background | Carboplatin | Small molecule | 6 unknown | Intravenous |
| Background | Paclitaxel | Small molecule | 175 mg/m2 | Intravenous |