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

Fallopian Tube Cancer Clinical Trial

— EHNPCTASEOC  

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03180177
• Other study ID #: HIPEC-03
• Status: Not yet recruiting
• Phase: Phase 3
• First received: June 6, 2017
• Last updated: January 22, 2018
• Start date: March 1, 2018
• Est. completion date: July 1, 2022

Study information

• Verified date: January 2018
• Source: Affiliated Tumor Hospital of Guangzhou Medical University
• Contact: Shuzhong Cui, M.D
• Phone: 0086-138-0251-3800
• Email: cuishuzhong[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 263
• Est. completion date: July 1, 2022
• Est. primary completion date: July 1, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Epithelial Ovarian Cancer
• Fallopian Tube Cancer
• Fallopian Tube Neoplasms
• Neoplasms, Glandular and Epithelial
• Ovarian Neoplasms
• Primary Peritoneal Carcinoma

Intervention

Procedure:
• Hyperthermic Intraperitoneal Chemotherapy
HIPEC is performed as neoadjuvant chemotherapy(NACT) and postoperative chemotherapy after interval debulking surgery (IDS) for advanced-stage epithelial ovarian cancer. The first HIPEC is conducted within 24h after laparoscopic exploration or Interval debulking surgery: Paclitaxel 175 mg/m^2, 43°C, 90min. The second HIPEC is performed after 48 hours of the first HIPEC. The second HIPEC regimens are cisplatin 75 mg/m^2, 43°C, 90min.
• Interval debulking surgery
Cytoreductive surgery (CRS) is performed after neoadjuvant chemotherapy.

Drug:
• neoadjuvant chemotherapy
Systemic chemotherapy regimens after HIPEC treatment are paclitaxel 175 mg/m^2 IV>3 hour+ carboplatin AUC = 5-6 IV>1 hour, every 3 weeks for 2 cycles in experimental group. Systemic chemotherapy regimens after laparoscopic exploration are paclitaxel 175 mg/m^2 IV>3 hour+ carboplatin AUC = 5-6 IV>1 hour, every 3 weeks for 3 cycles in control group.
• adjuvant chemotherapy
Systemic chemotherapy regimens after HIPEC treatment are paclitaxel 175 mg/m^2 IV>3 hour+ carboplatin AUC = 5-6 IV>1 hour, every 3 weeks for 2 cycles in experimental group. Systemic chemotherapy regimens after IDS are paclitaxel 175 mg/m^2 IV>3 hour+ carboplatin AUC = 5-6 IV>1 hour, every 3 weeks for 3 cycles in control group.

Locations

Country	Name	City	State
China	Department of Abdominal Surgery (Section 2), Affiliated Tumor Hospital of Guangzhou Medical University	Guangzhou	Guangdong

Sponsors (28)

Lead Sponsor

Collaborator

Shu-Zhong Cui

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, 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

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PR/SD rate	calculate the percent of partial remission (PR) plus stable disease (SD) of patients received HIPEC+NACT or NACT alone in both two arms	Through study completion, an average of 1 year
Primary	Percentage of optimal debulking surgery	evaluate the percentage of optimal debulk (residual disease < 1cm) after interval debulking surgery between study arms	Through study completion, an average of 1 year
Primary	Disease-free survival rate	assess disease free survival rate during 3 years in both study arms	3 years
Secondary	Overall survival rate	assess overall survival rate during 3 years in both study arms	3 years
Secondary	Risk factors for morbidity and mortality	determine percent of patients wtih Grade I-IV adverse events according to NCI criteria, Common Terminology Criteria for AE (CTCAE 4.0).	Through study completion, an average of 1 year
Secondary	Quality of life	Evaluated according to European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Cancer (EORTC QLQ-C30)	3 years
Secondary	Quality of life for ovarian cancer	Evaluated according to European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Ovarian Cancer Module (QLQ-OV28)	3 years