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
| Registry | NCT03180177, acronym EHNPCTASEOC |
|---|---|
| Status | Unknown |
| Phase | Phase 3 |
| Study type | Interventional; randomized, parallel, masking: single, treatment |
| Enrollment | 263 (Estimated) |
| Sponsor | Shu-Zhong Cui (Other); collaborators: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, Third Affiliated Hospital, Sun Yat-Sen University, Henan Provincial People's Hospital, Xiangya Hospital of Central South University, The Third Xiangya Hospital of Central South University, Peking University Cancer Hospital & Institute, Peking University People's Hospital, Cancer Hospital of Guizhou Province, Chinese PLA General Hospital, Hebei Medical University Fourth Hospital, The Second Hospital of Hebei Medical University, West China Second University Hospital, Peking Union Medical College Hospital, First Affiliated Hospital, Sun Yat-Sen University, Henan Cancer Hospital, Tianjin Medical University Cancer Institute and Hospital, The Third Affiliated Hospital of Guangzhou Medical University, Wuhan University, RenJi Hospital, Obstetrics & Gynecology Hospital of Fudan University, Southern Medical University, China, Fourth Affiliated Hospital of Guangxi Medical University, Shandong Cancer Hospital and Institute, Beijing Obstetrics and Gynecology Hospital, Chongqing Cancer Institute, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Xinqiao Hospital of Chongqing |
| Conditions | Epithelial Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Carcinoma |
| Interventions | Hyperthermic Intraperitoneal Chemotherapy, Interval debulking surgery, neoadjuvant chemotherapy, adjuvant chemotherapy (Procedure, drug) |
| Dates | start 2018-03-01 (estimated), primary completion 2021-07-01 (estimated), completion 2022-07-01 (estimated), first posted 2017-06-08, last updated 2018-01-24 |
| Locations | 1 site in China |
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All trials for Epithelial Ovarian Cancer All trials for Fallopian Tube Cancer All trials of Hyperthermic Intraperitoneal Chemotherapy All trials of Interval debulking surgery
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.
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Experimental group | Experimental | Procedure: Hyperthermic Intraperitoneal Chemotherapy; Procedure: Interval debulking surgery; Drug: neoadjuvant chemotherapy; Drug: adjuvant chemotherapy | 1. Hyperthermic Intraperitoneal Chemotherapy (HIPEC) with paclitaxel 175 mg/m\^2 and cisplatin 75 mg/m\^2 intraperitoneally in succession 2. 2 cycles of neoadjuvant chemotherapy: paclitaxel 175 mg/m\^2 IV>3 hour+ carboplatin AUC = 5-6 IV>1 hour, every 3 weeks 3. Interval debulking surgery 4. Hyperthermic Intraperitoneal Chemotherapy (HIPEC) with paclitaxel 175 mg/m\^2 and cisplatin 75 mg/m\^2 intraperitoneally in succession 5. 2 cycles of adjuvant chemotherapy: paclitaxel 175 mg/m\^2 IV>3 hour+ carboplatin AUC = 5-6 IV>1 hour, every 3 weeks |
| Control group | Active comparator | Procedure: Interval debulking surgery; Drug: neoadjuvant chemotherapy; Drug: adjuvant chemotherapy | 1. 3 cycles of neoadjuvant chemotherapy: paclitaxel 175 mg/m\^2 IV>3 hour+ carboplatin AUC = 5-6 IV>1 hour, every 3 weeks 2. Interval debulking surgery 3. 3 cycles of adjuvant chemotherapy: paclitaxel 175 mg/m\^2 IV>3 hour+ carboplatin AUC = 5-6 IV>1 hour, every 3 weeks |
Sex: Female, ages: 18 Years to 70 Years
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
| Facility | City | Country | Status |
|---|---|---|---|
| Department of Abdominal Surgery (Section 2), Affiliated Tumor Hospital of Guangzhou Medical University | Guangzhou, Guangdong | China |