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

Last updated: May 28, 2020
Sponsor: Zhongnan Hospital
Overall Status: Active - Not Recruiting

Phase

3

Condition

Ovarian Cancer

Fever

Vaginal Cancer

Treatment

N/A

Clinical Study ID

NCT03371693
HIPECOV
  • Ages 18-75
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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; firstintra-abdominal recurrence without distant metastasis (including: unique resectablepleural metastasis which are platinum-sensitive; resectable single lymphaticmetastasis retroperitoneal or inguinal)

  • preoperative platinum-based chemotherapy (carboplatin and paclitaxel, carboplatin andliposomal 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 ≥3.510^9/L; platelet count ≥8010^9/L; Hemoglobin ≥90g/L

  • no contraindication of surgery and anesthesia

  • life expectancy ≥ 3 months

Exclusion

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

Study Design

Total Participants: 112
Study Start date:
September 30, 2017
Estimated Completion Date:
March 30, 2023

Study 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.

Connect with a study center

  • Zhongnan Hospital of Wuhan University

    Wuhan, Hubei 430072
    China

    Site Not Available

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