Clinical trial NCT03180177: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Epithelial Ovarian Cancer
Fallopian Tube Cancer
Primary Peritoneal Carcinoma
Keywords: Hyperthermic Intraperitoneal Chemotherapy
Neoadjuvant Chemotherapy
Interval Debulking Surgery
Advanced-Stage Epithelial Ovarian Cancer
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 Cancer Institute
name: Wuhan Union Hospital, China
name: Xinqiao Hospital of Chongqing
First posted: 2017-06-08
Enrollment: 263
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 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.

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

Primary outcomes:
measure: PR/SD rate
timeFrame: Through study completion, an average of 1 year
measure: Percentage of optimal debulking surgery
timeFrame: Through study completion, an average of 1 year
measure: Disease-free survival rate
timeFrame: 3 years
Secondary outcomes:
measure: Overall survival rate
timeFrame: 3 years
measure: Risk factors for morbidity and mortality
timeFrame: Through study completion, an average of 1 year
measure: Quality of life
timeFrame: 3 years
measure: Quality of life for ovarian cancer
timeFrame: 3 years
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Department of Abdominal Surgery (Section 2), Affiliated Tumor Hospital of Guangzhou Medical University
state: Guangdong
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: