Clinical trial NCT03373058: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Epithelial Ovarian Cancer
Fallopian Tube Cancer
Primary Peritoneal Carcinoma
Keywords: Hyperthermic Intraperitoneal Chemotherapy
Advanced-Stage Epithelial Ovarian Cancer
Cytoreductive surgery
Postoperative Chemotherapy
Lead sponsor: Affiliated Cancer Hospital & Institute of Guangzhou Medical University
Sponsor class: OTHER
Collaborators: name: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
name: Third Affiliated Hospital, Sun Yat-Sen University
name: Henan Provincial People's Hospital
name: Xiangya Hospital of Central South University
name: The Third Xiangya Hospital of Central South University
name: Peking University Cancer Hospital & Institute
name: Peking University People's Hospital
name: Cancer Hospital of Guizhou Province
name: Chinese PLA General Hospital
name: Hebei Medical University Fourth Hospital
name: The Second Hospital of Hebei Medical University
name: West China Second University Hospital
name: Peking Union Medical College Hospital
name: First Affiliated Hospital, Sun Yat-Sen University
name: Henan Cancer Hospital
name: Tianjin Medical University Cancer Institute and Hospital
name: The Third Affiliated Hospital of Guangzhou Medical University
name: Wuhan University
name: RenJi Hospital
name: Obstetrics & Gynecology Hospital of Fudan University
name: Southern Medical University, China
name: Fourth Affiliated Hospital of Guangxi Medical University
name: Shandong Cancer Hospital and Institute
name: Beijing Obstetrics and Gynecology Hospital
name: Chongqing University Cancer Hospital
name: Xinqiao Hospital of Chongqing
name: Wuhan Union Hospital, China
name: First Affiliated Hospital of Chongqing Medical University
name: Affiliated Cancer Hospital of Shantou University Medical College
First posted: 2017-12-14
Enrollment: 310
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Median recurrence-free survival
timeFrame: 3 years
Secondary outcomes:
measure: Median overall survival
timeFrame: 3 years
measure: Median progression-free survival
timeFrame: 3 years
measure: Risk factors for morbidity and mortality
timeFrame: 30 days; 3 years
measure: Quality of life for ovarian cancer
timeFrame: 3 years
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Affiliated Tumor Hospital of Guangzhou Medical University
state: Guangdong
city: Guanzhou
country: China
facility: Sun Yat-sen Memorial Hospital,Sun Yat-sen University
state: Guangdong
city: Beijing
country: China
facility: Beijing Cancer Hospital
city: Chongqing
country: China
facility: Chongqing Cancer Hospital
city: Chongqing
country: China
facility: The First Affiliated Hospital of Chongqing Medical University
city: Wuhan
country: China
facility: Hubei General Hospital
city: Zhengzhou
country: China
facility: Henan Cancer Hospital
Study officials:
affiliation: Affiliated Cancer Hospital & Institute of Guangzhou Medical University
name: Shuzhong Cui, M.D
role: STUDY_DIRECTOR
affiliation: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
name: Zhongqiu Lin, M.D
role: STUDY_DIRECTOR
References: