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.

Phase 1

• Conditions: ovarian peritoneal carcinomatosis; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2014-002850-38-ES
• Lead Sponsor: FUNDACIÓN PARA LA INVESTIGACIÓN BIOMÉDICA DE CÓRDOBA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-10-16
• Last Update Posted: 26 September 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 60

Inclusion Criteria

1) Women, aged > 18 and < 65 years
2) Epithelial ovarian peritoneal carcinomatosis (FIGO stage III c) of
primary or recurrent diagnosis
3) Radical cytoreductive surgery with HIPEC procedures peritonectomy and achieving optimal cytoreduction without macroscopic residue (R0)
4) Body mass index (BMI) ? 30
5) Classification ASA (American Society of Anesthesiologists) I-II
6) Karnofsky Index> 70 or performance status <2
7) Informed consent duly completed
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 60
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified