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

• Status: Not yet recruiting
• Trial end date: 2022-07-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shu-Zhong Cui
• Collaborators: Beijing Cancer Hospital; Beijing Obstetrics and Gynecology Hospital; Cancer Hospital of Guizhou Province; Chinese PLA General Hospital; Chongqing Cancer Institute; First Affiliated Hospital, Sun Yat-Sen University; Fourth Affiliated Hospital of Guangxi Medical University; Hebei Medical University Fourth Hospital; Henan Cancer Hospital; Henan Provincial Hospital; Henan Provincial People's Hospital; Obstetrics & Gynecology Hospital of Fudan University; Peking Union Medical College Hospital; Peking University People's Hospital; RenJi Hospital; Shandong Cancer Hospital and Institute; Southern Medical University, China; Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University; The Second Hospital of Hebei Medical University; The Third Affiliated Hospital of Guangzhou Medical University; The Third Xiangya Hospital of Central South University; Third Affiliated Hospital, Sun Yat-Sen University; Tianjin Medical University Cancer Institute and Hospital; West China Second University Hospital; Wuhan Union Hospital, China; Wuhan University; Xiangya Hospital of Central South University; Xinqiao Hospital of Chongqing
• Treatments: Albumin-Bound Paclitaxel; Carboplatin; Paclitaxel

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