Efficacy of HIPEC as NACT and Postoperative Chemotherapy in the Treatment of Advanced-Stage Epithelial Ovarian Cancer

Brief Title

Efficacy of HIPEC as NACT and Postoperative Chemotherapy in the Treatment of Advanced-Stage Epithelial Ovarian Cancer

Official Title

A Phase III Multicenter Prospective Randomized Controlled Clinical Trial of HIPEC as NACT and Postoperative Chemotherapy After Interval Debulking Surgery in the Treatment of Advanced-Stage Epithelial Ovarian Cancer

Brief Summary

      This project is a multi-center, prospective, randomized controlled clinical observation the
      safety and efficacy of hyperthermic intraperitoneal chemotherapy as neoadjuvant
      chemotherapy(NACT) and postoperative chemotherapy after interval debulking surgery (IDS) for
      advanced-stage epithelial ovarian cancer . PR/SD rate, percentage of optimal debulking
      surgery and 3-year disease-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 a high perioperative risk profile or a low likelihood of
      achieving cytoreduction to < 1 cm of residual disease (ideally to novisible disease) should
      receive neoadjuvant chemotherapy.

      Hyperthermia promotes chemotherapy to penetrate deeper into the cancer tissue. Therefore,
      hyperthermic intraperitoneal chemotherapy (HIPEC) as neoadjuvant chemotherapy and
      postoperative chemotherapy after interval debulking 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

PR/SD rate

Secondary Outcome

 Overall survival rate

Condition

Epithelial Ovarian Cancer

Intervention

Hyperthermic Intraperitoneal Chemotherapy

Study Arms / Comparison Groups

 Experimental group

Description:  Hyperthermic Intraperitoneal Chemotherapy (HIPEC) with paclitaxel 175 mg/m^2 and cisplatin 75 mg/m^2 intraperitoneally in succession
2 cycles of neoadjuvant chemotherapy: paclitaxel 175 mg/m^2 IV>3 hour+ carboplatin AUC = 5-6 IV>1 hour, every 3 weeks
Interval debulking surgery
Hyperthermic Intraperitoneal Chemotherapy (HIPEC) with paclitaxel 175 mg/m^2 and cisplatin 75 mg/m^2 intraperitoneally in succession
2 cycles of adjuvant chemotherapy: paclitaxel 175 mg/m^2 IV>3 hour+ 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

March 1, 2018

Completion Date

July 1, 2022

Primary Completion Date

July 1, 2021

Eligibility Criteria

        Inclusion Criteria:

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

          -  Fagotti score by laparoscopic exploration >= 6

          -  After receiving HIPEC+neoadjuvant chemotherapy (NACT) or NACT alone, the curative
             effects evaluated according to RICIST criteria is partial remission (PR) and stable
             disease (SD).

          -  Residual tumor < 1cm after completion of interval debulking 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

          -  After receiving HIPEC+neoadjuvant chemotherapy (NACT) or NACT alone, the progression
             of disease (PD) is evaluated by doctor.

          -  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

NCT03180177

Organization ID

HIPEC-03

Responsible Party

Sponsor-Investigator

Study Sponsor

Shu-Zhong Cui

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

January 2018