Study to evaluate the benefit and safety of a drug, paclitaxel, in the treatment of advanced ovarian cancer by applying intraperitoneally for three hours a day in the days following surgery, in which disease malignant ovarian tumor was removed and chemotherapy was administered hyperthermic intraoperative intraperitoneally.

EFFICACY AND SAFETY OF EARLY POSTOPERATIVE CHEMOTHERAPY INTRAPERITONEAL (EPIC) WITH PACLITAXEL IN THE RADICAL SURGERY TREATMENT OF OVARIAN PERITONEAL CARCINOMATOSIS

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2014-002850-38-ES

Enrollment

Registered

2014-10-16

Start date

2015-05-21

Completion date

Unknown

Last updated

2023-09-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ovarian peritoneal carcinomatosis

Interventions

Trade Name: Taxol Pharmaceutical Form: Intraperitoneal solution INN or Proposed INN: PACLITAXEL CAS Number: 33069-62-4

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Women, aged > 18 and 70 or performance status =65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: 1) Not meeting the inclusion criteria 2) Presence of distant metastases or stage IV FIGO 3) Coexistence of other malignant neoplasm 4) Hepatic, renal or cardiovascular function altered 5) More than 2 previous intravenous chemotherapy schemes 6) Have received prior chemotherapy except intraperitoneal-diagnostic staging laparoscopy 7) More than 2 previous surgical interventions ovarian neoplasia 8) More than 2 complete bowel anastomosis 9) Treatment intolerance 10) Waiver of the patient to participate in the study

Design outcomes

Primary

Measure	Time frame
Main Objective: Evaluate the efficacy and safety of early postoperative intraperitoneal chemotherapy (EPIC) with paclitaxel after radical peritonectomy and intraoperative hyperthermic intraperitoneal chemotherapy (HIPEC) in patients with ovarian peritoneal carcinomatosis;Secondary Objective: 1) Evaluate morbility (Dindo-Clavien scale) of EPIC in the 3-day treatment group versus no EPIC 2) Evaluate morbility associated with the two treatment regimens in terms of myelosuppression and the need for blood transfusion or colony stimulating factors, and possible relative to the plasma levels of paclitaxel 3) Evaluate paclitaxel plasma concentrations reached in the two treatment groups 4) Evaluate response of the tumor marker Ca 125 after optimal cytoreduction R0 in the two treatment groups applied 5) Analyze hospital stay and time to full recovery of routine physical activity in the two treatment groups 6) Analyze postoperative mortality, and disease free survival 7) Analyze possible prognostic factors for survival;Primary end point(s): Global survival time;Timepoint(s) of evaluation of this end point: Hospital discharge, 30 days, 90 days, 180 days, 360 days, 540 days, 720 days	—

Measure

Time frame

Main Objective: Evaluate the efficacy and safety of early postoperative intraperitoneal chemotherapy (EPIC) with paclitaxel after radical peritonectomy and intraoperative hyperthermic intraperitoneal chemotherapy (HIPEC) in patients with ovarian peritoneal carcinomatosis;Secondary Objective: 1) Evaluate morbility (Dindo-Clavien scale) of EPIC in the 3-day treatment group versus no EPIC 2) Evaluate morbility associated with the two treatment regimens in terms of myelosuppression and the need for blood transfusion or colony stimulating factors, and possible relative to the plasma levels of paclitaxel 3) Evaluate paclitaxel plasma concentrations reached in the two treatment groups 4) Evaluate response of the tumor marker Ca 125 after optimal cytoreduction R0 in the two treatment groups applied 5) Analyze hospital stay and time to full recovery of routine physical activity in the two treatment groups 6) Analyze postoperative mortality, and disease free survival 7) Analyze possible prognostic factors for survival;Primary end point(s): Global survival time;Timepoint(s) of evaluation of this end point: Hospital discharge, 30 days, 90 days, 180 days, 360 days, 540 days, 720 days

—

Secondary

Measure	Time frame
Secondary end point(s): - Morbility and mortality postoperative - Disease-free time;Timepoint(s) of evaluation of this end point: - Morbility and mortality postoperative : hospital discharge - Disease-free time: hospital discharge, 30 days, 90 days, 180 days, 360 days, 540 days, 720 days	—

Countries

Spain

Contacts

Public ContactUNIDAD ENSAYOS CLÍNICOS

FUNDACIÓN PARA LA INVESTIGACIÓN BIOMÉDICA DE CÓRDOBA

isabel.bejerano@imibic.org+34957011266

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026