Short-course HIPEC in Advanced Epithelial Ovarian Cancer

PHASE2CompletedINTERVENTIONAL
Enrollment

15

Participants

Timeline

Start Date

February 28, 2015

Primary Completion Date

February 23, 2021

Study Completion Date

February 23, 2021

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.

All Listed Sponsors
collaborator

Hospital de Câncer de Pernambuco (Recife/PE)

UNKNOWN

collaborator

AC Camargo Cancer Center (São Paulo/SP)

UNKNOWN

collaborator

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

UNKNOWN

collaborator

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

UNKNOWN

collaborator

Hospital Sao Jose (Criciuma/SC)

UNKNOWN

collaborator

Hospital de Base do Distrito Federal (Brasilia/DF)

UNKNOWN

lead

Professor Fernando Figueira Integral Medicine Institute

OTHER

NCT02249013 - Short-course HIPEC in Advanced Epithelial Ovarian Cancer | Biotech Hunter | Biotech Hunter