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

NCT03371693 | Unknown Phase 3

• 1 other identifier: HIPECOV
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

hyperthermic intraperitoneal chemotherapy; epithelial ovarian cancer

Outcome Measures

Primary Outcomes (3)

• Overall Survival rate

  assess overall survival rate in 5 years in both arms

  5 years

• 1 year survival rate

  assess the survival rate in 1 year for both arms

  1 year

• 3 year survival rate

  assess the survival rate in 3 years for both arms

  3 years

Secondary Outcomes (3)

• Progression-free survival

  5 years

• quality of life

  5 years after CRS or until death

• postoperative complication

  5 years

Study Arms (2)

HIPEC

EXPERIMENTAL

Patients will undergo a CRS plus HIPEC and IVCT. Hyperthermic intraperitoneal chemotherapy (HIPEC) is a procedure in which the abdominal cavity is bathed in a warm solution of anti-cancer medications for 60 minutes. A single drug lobaplatin(30mg/m2)will be administered in normal saline via HIPEC and it will be continued for 60 minutes in the hyperthermic phase (41°C-43°C). HIPEC will be performed at the 1st, 3rd and 5th day after CRS. The intravenous chemotherapy(IVCT) will start from 7th-14th day after CRS.

Device: HIPEC; Device: CRS; Device: IVCT

Non HIPEC

OTHER

Patients will undergo only CRS and IVCT. Patients will receive standard platinum-based combination doublet chemotherapy for 6-8 cycles after CRS.

Device: CRS; Device: IVCT

Interventions

HIPEC DEVICE

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.

HIPEC

CRS DEVICE

cytoreductive surgery (CRS) to a residual disease ≤ 2.5 mm.

HIPEC; Non HIPEC

IVCT DEVICE

platinum-based intravenous chemotherapy

HIPEC; Non HIPEC

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Zhongnan Hospital: lead

Study Sites (1)

Zhongnan Hospital of Wuhan University

Wuhan, Hubei, 430072, China

Location

MeSH Terms

Conditions

Ovarian Neoplasms; Carcinoma, Ovarian Epithelial

Interventions

Hyperthermic Intraperitoneal Chemotherapy

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Chemotherapy, Adjuvant; Combined Modality Therapy; Therapeutics; Drug Therapy; Hyperthermia, Induced

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Wuhan University, MD, PhD, Chef of the Department of Gynecological Oncology of Zhongnan Hospital, member of the standing committee of Chinese Gynecologic Cancer Society

Study Record Dates

• First Submitted: November 27, 2017
• First Posted: December 13, 2017
• Study Start: September 30, 2017
• Primary Completion: December 30, 2022
• Study Completion: March 30, 2023
• Last Updated: May 29, 2020

Record last verified: 2020-05

Locations

CN (1)