Stage IIIC unresectable epithelial ovarian/tubal cancer with partial or complete response after 1st line neoadjuvant chemotherapy (3 cycles CBDCA+Paclitaxel): a phase 3 prospective randomized study comparing cytoreductive surgery + hyperthermic intraperitoneal chemotherapy (CDDP+Paclitaxel) + 3 cycles CBDCA+Paclitaxel vs cytoreductive surgery alone + 3 cycles CBDCA+Paclitaxel. - CHORINE

AZIENDA OSPEDALIERA OSPEDALI RIUNITI DI BERGAMO (A.O. DI RILIEVO NAZIONALE)0 个研究点开始时间: 2012年6月7日最近更新: 2013年1月7日

适应症

试验速览

暂无简介。

•1.Female adult women (18 to 70 years old) 2.patients, with EOC (FIGO stage IIIc, with a Fagotti modified Laparoscopic Scoring System = 4 3. who will show a complete clinical response (cCR) or partial clinical response (cPR) after 3 cycles (Carboplatin+Paclitaxel) of neoadjuvant chemotherapy; 4. performance status (ECOG) 0, 1 or 2 5. signed informed consent.
•Are the trial subjects under 18? no
•Number of subjects for this age range: 0
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 90
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 4

•refusing to sign an informed consent; • age > 70 years and age <18 years; • BMI > 35; • impossibility of an adequate follow-up; • presence of other active neoplasms; • active infection or other concurrent medical condition that could interfere in the ability of patients to receive the proposed treatment according to protocol; • extraabdominal metastases (Stage IV) ; • performance status (ECOG)>2; • complete bowel obstruction; • Abnormal bone marrow indices or renal and liver function; • ASA IV or V.

发起方

AZIENDA OSPEDALIERA OSPEDALI RIUNITI DI BERGAMO (A.O. DI RILIEVO NAZIONALE)