Epithelial Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Carcinoma
Conditions
Keywords
Hyperthermic Intraperitoneal Chemotherapy, Neoadjuvant Chemotherapy, Interval Debulking Surgery, Advanced-Stage Epithelial Ovarian Cancer, Postoperative Chemotherapy
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.
Interventions
PROCEDUREHyperthermic 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.
PROCEDUREInterval debulking surgery
Cytoreductive surgery (CRS) is performed after neoadjuvant chemotherapy.
DRUGneoadjuvant 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.
DRUGadjuvant 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.
Sponsors
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
Shu-Zhong Cui
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PR/SD rate | Through study completion, an average of 1 year | calculate the percent of partial remission (PR) plus stable disease (SD) of patients received HIPEC+NACT or NACT alone in both two arms |
| Percentage of optimal debulking surgery | Through study completion, an average of 1 year | evaluate the percentage of optimal debulk (residual disease \< 1cm) after interval debulking surgery between study arms |
| Disease-free survival rate | 3 years | assess disease free survival rate during 3 years in both study arms |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival rate | 3 years | assess overall survival rate during 3 years in both study arms |
| Quality of life for ovarian cancer | 3 years | Evaluated according to European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Ovarian Cancer Module (QLQ-OV28) |
| Risk factors for morbidity and mortality | Through study completion, an average of 1 year | determine percent of patients wtih Grade I-IV adverse events according to NCI criteria, Common Terminology Criteria for AE (CTCAE 4.0). |
| Quality of life | 3 years | Evaluated according to European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Cancer (EORTC QLQ-C30) |
Countries
China
Contacts
Primary ContactShuzhong Cui, M.D
Backup ContactXianzi Yang, M.D
Outcome results
None listed