Efficacy of HIPEC in the Treatment of Advanced-Stage Epithelial Ovarian Cancer After Cytoreductive Surgery

Brief Title

Efficacy of HIPEC in the Treatment of Advanced-Stage Epithelial Ovarian Cancer After Cytoreductive Surgery

Official Title

A Phase III Multicenter Prospective Randomized Controlled Clinical Trial of Hyperthermic Intraperitoneal Chemotherapy in the Treatment of Advanced-Stage Epithelial Ovarian Cancer After Cytoreductive Surgery

Brief Summary

      This project is a multi-center, prospective, randomized controlled clinical observation the
      safety and efficacy of hyperthermic intraperitoneal chemotherapy in the treatment of
      advanced-stage epithelial ovarian cancer after cytoreductive surgery. Median recurrence-free
      survival is the primary end points of this project.

Detailed Description

      The current standard treatment for epithelial ovarian cancer, tubal cancer, and primary
      peritoneal cancer is maximal cytoreductive surgery followed by intravenous chemotherapy with
      or without intraperitoneal chemotherapy (IP). Recently, the organizations of SGO and ASCO
      recommended that women with Fagotti score by laparoscopic exploration < 6 would benefit from
      primary cytoreductive surgery followed by postoperative chemotherapy, and are likely to
      attain optimal cytoreduction (residual lesion ≤ 1 cm).

      Hyperthermia promotes chemotherapy to penetrate deeper into the cancer tissue. Therefore,
      hyperthermic intraperitoneal chemotherapy (HIPEC) as newly postoperative chemotherapy after
      primary cytoreductive surgery in the treatment of ovarian cancer could lead to higher
      response rate and better survival outcomes.

Study Phase

Phase 3

Study Type

Interventional

Primary Outcome

Median recurrence-free survival

Secondary Outcome

 Median overall survival

Condition

Epithelial Ovarian Cancer

Intervention

Hyperthermic Intraperitoneal Chemotherapy

Study Arms / Comparison Groups

 Experimental group

Description:  Cytoreductive surgery
Hyperthermic Intraperitoneal Chemotherapy (HIPEC) with Docetaxel 75 mg/m^2 and cisplatin 75 mg/m^2 intraperitoneally in succession
6 cycles of adjuvant chemotherapy: paclitaxel 175 mg/m^2 IV>3 hour(Docetaxel 75 mg/m^2, if paclitaxel is not available.)+ carboplatin AUC = 5-6 IV>1 hour, every 3 weeks.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Procedure

Estimated Enrollment

Start Date

October 15, 2019

Completion Date

July 1, 2023

Primary Completion Date

July 1, 2021

Eligibility Criteria

        Inclusion Criteria:

          -  Disease status primary epithelial ovarian cancer, tubal cancer, and primary peritoneal
             cancer (Stage III )

          -  Fagotti score by laparoscopic exploration < 6

          -  Residual tumor < 1cm after completion of cytoreductive surgery

          -  18 < Age < 70 year old

          -  Expected survival > 3 months

          -  Performance status: ECOG 0-1

          -  Adequate bone marrow function Hb ≥8 g/dl (After correction in case of iron deficient
             anemia) WBC ≥ 3,000/mm3, Platelet ≥ 100,000/mm3

          -  Adequate renal function Creatinine ≤ 1.5 mg/dl, and adequate hepatic function
             Bilirubin ≤ 1.5 mg/dl and AST and ALT ≤ 80 IU/L

          -  Voluntary participation after getting written informed consent.

        Exclusion Criteria:

          -  Fagotti score by laparoscopic exploration >= 6

          -  Suboptimal debulking (residual tumor > 1cm)

          -  Extensive adhesion in peritoneal cavity

          -  Previous History of other malignancies (except excision of skin cancer, thyroid
             cancer)

          -  Poorly controlled disease e.g. atrial fibrillation, stenocardia, cardiac
             insufficiency, persistent hypertension despite medicinal treatment, ejection
             fraction<50%

          -  Receiving other chemotherapy, radiotherapy or immunotherapy

          -  Patients who are unsuitable candidates by doctor's decision

          -  Without given written informed consent

Gender

Female

Ages

18 Years - 70 Years

Accepts Healthy Volunteers

No

Contacts

Shuzhong Cui, M.D, 0086-138-0251-3800, [email protected]

Location Countries

China

Location Countries

China

Administrative Informations

NCT ID

NCT03373058

Organization ID

HIPEC-03

Responsible Party

Sponsor

Study Sponsor

Affiliated Cancer Hospital & Institute of Guangzhou Medical University

Collaborators

 Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Study Sponsor

Shuzhong Cui, M.D, Study Director, Affiliated Cancer Hospital & Institute of Guangzhou Medical University

Verification Date

November 2019