Combined treatment of intraperitoneal chemotherapy after optimal interval surgery in advanced ovarian cancer

Phase 1

• Conditions: Ovarian cancer (OV-1); MedDRA version: 21.1Level: PTClassification code 10070907Term: Ovarian cancer stage IIISystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 21.1Level: PTClassification code 10070908Term: Ovarian cancer stage IVSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2022-001107-41-ES
• Lead Sponsor: Fundación para la Formación e Investigación Sanitarias de la Región de Murcia (FFIS)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-05-13
• Last Update Posted: 8 August 2022

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Female
• Target Recruitment: 20

Inclusion Criteria

- Women aged between 18-70 years with a proven histological diagnosis of FIGO stage IIIB-C/IV epithelial ovarian cancer (high grade serous epithelial carcinoma).
- Absence of extraperitoneal disease.
- Good functional status: Karnofsky index >70 or Performance status <=2.
- Optimal liver function, defined as bilirubin <0 1.5 times the upper limit of normal (ULN), aspartate aminotransferase and alanine aminotransferase <= 2.5 times ULN, and alkaline phosphatase <=3 times ULN.
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 15
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5

Exclusion Criteria

- Disease progression during systemic treatment with neoadjuvant chemotherapy.
- Extraperitoneal disease (including retroperitoneal lymph node metastases).
- Impossibility of achieving complete cytoreduction (CC-0), in the preoperative evaluation (imaging tests), or intraoperatively.
- Conduct of at least one digestive anstomosis of any nature.
- Active infection of any origin.
- Allogeneic transplant, or previous bone marrow transplant, or high dose chemotherapy with bone marrow or stem cell rescue.
- Beeing enrroled in a clinical trial with an investigational drug in the last 30 years.
- Not having given writing informed consent.

Study & Design

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