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

Ovarian Cancer Clinical Trial

— HIPECOV  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03371693
• Other study ID #: HIPECOV
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: September 30, 2017
• Est. completion date: March 30, 2023

Study information

• Verified date: May 2020
• Source: Zhongnan Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 112
• Est. completion date: March 30, 2023
• Est. primary completion date: December 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

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

Related Conditions & MeSH terms

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

Intervention

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.
• CRS
cytoreductive surgery (CRS) to a residual disease = 2.5 mm.
• IVCT
platinum-based intravenous chemotherapy

Locations

Country	Name	City	State
China	Zhongnan Hospital of Wuhan University	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Zhongnan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Survival rate	assess overall survival rate in 5 years in both arms	5 years
Primary	1 year survival rate	assess the survival rate in 1 year for both arms	1 year
Primary	3 year survival rate	assess the survival rate in 3 years for both arms	3 years
Secondary	Progression-free survival	assess the Progression-free survival rate during 5 years for both study arms	5 years
Secondary	quality of life	Patients will fill the EORTC Quality of life questionaire-C30 form to measure the quality of life after a standard treatment.	5 years after CRS or until death
Secondary	postoperative complication	measured with physical examination and/or computed tomography(CT)and/or ultrasound examination.	5 years