Short-course HIPEC in Advanced Epithelial Ovarian Cancer

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).

Conditions

• Ovarian Cancer

Interventions

PROCEDURE

Cytoreductive Surgery (CRS)

CRS was performed with standard peritonectomy procedures and visceral resections directed towards complete elimination of tumors from the abdominopelvic cavity.

PROCEDURE

Hyperthermic Intraperitoneal Chemotherapy (HIPEC)

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.

DRUG

Neoadjuvant Chemotherapy (NACT)

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.

DRUG

Adjuvant 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.

PROCEDURE

Fast-track recovery strategy

A comprehensive fast-track program was applied to accelerate recovery, reduce morbidity, and shorten convalescence for patients enrolled in our trial.

Sponsors & Collaborators

• Hospital de Câncer de Pernambuco (Recife/PE)

  collaborator UNKNOWN

• AC Camargo Cancer Center (São Paulo/SP)

  collaborator UNKNOWN

• Instituto Brasileiro de Controle do Câncer (São Paulo/SP)

  collaborator UNKNOWN

• Hospital de Cancer de Barretos - Fundacao Pio XII (Barretos/SP)

  collaborator UNKNOWN

• Hospital Sao Jose (Criciuma/SC)

  collaborator UNKNOWN

• Hospital de Base do Distrito Federal (Brasilia/DF)

  collaborator UNKNOWN

• Professor Fernando Figueira Integral Medicine Institute

  lead OTHER

Principal Investigators

• Thales P Batista, MD, MS · Professor Fernando Figueira Integral Medicine Institute

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2015-02-28

Primary Completion

2021-02-23

Completion

2021-02-23