Cytoreductive Surgery(CRS) Plus Hyperthermic Intraperitoneal Chemotherapy(HIPEC) With Lobaplatin in Advanced and Recurrent Epithelial Ovarian Cancer

Summary

A phase III prospective study with the primary objective to compare the efficacy and safety of HIPEC( Hyperthermic Intraperitoneal Chemotherapy). The target population for this study is patients with primary or recurrence ovarian, peritoneal or fallopian tube cancers undergoing CRS( Cytoreductive Surgery). Patients will be divided into two groups. Group A will undergo CRS plus HIPEC and then go on to receive standard platinum-based combination doublet intravenous chemotherapy. Group B will undergo CRS and then go on to intravenous chemotherapy.

Key Facts

Interventions

Conditions

Eligibility

Inclusion Criteria:

* age 18-75
* Karnofsky performance status \>50 or World Health Organization performance score \< 2
* primary or recurrence ovarian, peritoneal or fallopian tube epithelial cancer; first intra-abdominal recurrence without distant metastasis (including: unique resectable pleural metastasis which are platinum-sensitive; resectable single lymphatic metastasis retroperitoneal or inguinal)
* preoperative platinum-based chemotherapy (carboplatin and paclitaxel, carboplatin and liposomal doxorubicin, gemcitabine, trabectedin or topotecan)
* lesion can be removed completely or residual disease \< 0.5 cm
* last chemotherapy finished no more than 12 weeks after surgery
* no hepatic function damage
* white blood cell count ≥3.5\*10\^9/L; platelet count ≥80\*10\^9/L; Hemoglobin ≥90g/L
* no contraindication of surgery and anesthesia
* life expectancy ≥ 3 months

Exclusion Criteria:

* age \< 18 or \>75
* no history of other cancer
* platinum allergy
* distant metastasis
* used anti-angiogenic drug within 8 weeks
* possibility of more than two resection of alimentary canal
* recurrence \< 6 months after primary treatment
* histologic type: non epithelial origin
* infection out of control
* follow-up unable to carry on (geographic or psychic)
* cardiac insufficiency or respiratory insufficiency
* has received HIPEC already
* being in other clinical study
* pregnancy or lactation period

Outcome Measures

Locations

Linked Diseases