NCT03371693

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

A Phase III Clinical Trail of Cytoreductive Surgery(CRS) Plus Hyperthermic Intraperitoneal Chemotherapy(HIPEC) With Lobaplatin in Advanced and Recurrent Epithelial Ovarian Cancer

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 112 (actual)
• Sponsor: Zhongnan Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a phase III prospective study with the primary objective to compare the efficacy and safety of HIPEC. The target population for this study is patients with primary or recurrence ovarian, peritoneal or fallopian tube cancers undergoing CRS. 'Platinum-sensitive' recurrence is defined as recurrence 6 months after the completion of the primary platinum-based chemotherapy. A single dose of lobaplatin 40mg/m2 will be administered via HIPEC , and will be administered at the time of surgery, 3 days after surgery and 5 days after surgery. Patients of group A will undergo CRS plus HIPEC and then go on to receive standard platinum-based combination doublet intravenous chemotherapy (carboplatin and paclitaxel, carboplatin and gemcitabine, or carboplatin and liposomal doxorubicin) for 6 cycles. Patients of group B will undergo CRS and then go on to intravenous chemotherapy.

Conditions

• Ovarian Cancer
• Ovary Neoplasm
• Ovarian Neoplasms
• Epithelial Ovarian Cancer
• Ovarian Cancer, Epithelial
• Hyperthermic Intraperitoneal Chemotherapy(HIPEC)

Interventions

Type	Name	Description
DEVICE	HIPEC	Patients consenting to this protocol will undergo their scheduled surgical procedure. After cytoreductive surgery (CRS) to a residual disease ≤ 2.5 mm, a single dose of lobaplatin (30 mg/m2) will be administered in normal saline via intraperitoneal hyperthermic perfusion using the closed-abdomen technique. HIPEC will be continued for 60 minutes in the hyperthermic phase (43℃±0.5℃). And HIPEC will be repeated at the 3 and 5 day after the day of CRS plus HIPEC.
DEVICE	CRS	cytoreductive surgery (CRS) to a residual disease ≤ 2.5 mm.
DEVICE	IVCT	platinum-based intravenous chemotherapy

Timeline

• Start date: 2017-09-30
• Primary completion: 2022-12-30
• Completion: 2023-03-30
• First posted: 2017-12-13
• Last updated: 2020-05-29

Locations

1 site across 1 country: China