Short-course HIPEC in Advanced Epithelial Ovarian Cancer

• Status: Completed
• Trial end date: 2021-02-23
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Professor Fernando Figueira Integral Medicine Institute
• Collaborators: AC Camargo Cancer Center; AC Camargo Cancer Center (São Paulo/SP); Hospital de Base do Distrito Federal (Brasilia/DF); Hospital de Cancer de Barretos - Fundacao Pio XII (Barretos/SP); Hospital de Câncer de Pernambuco; Hospital de Câncer de Pernambuco (Recife/PE); Hospital Sao Jose (Criciuma/SC); Instituto Brasileiro de Controle do Câncer (São Paulo/SP)
• Treatments: Albumin-Bound Paclitaxel; Carboplatin; Paclitaxel

Criteria

• 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.