Combined treatment of intraperitoneal chemotherapy after optimal interval surgery in advanced ovarian cancer - BICOV-1

Fundación para la Formación e Investigación Sanitarias de la Región de Murcia (FFIS)0 个研究点目标入组 20 人开始时间: 2022年5月13日最近更新: 2022年8月8日

适应症

试验速览

暂无简介。

•- 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

•- 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.

发起方

Fundación para la Formación e Investigación Sanitarias de la Región de Murcia (FFIS)