Efficacy of HIPEC as NACT and Postoperative Chemotherapy in the Treatment of Advanced-Stage Epithelial Ovarian Cancer
NCT ID: NCT03180177
Last Updated: 2018-01-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
263 participants
INTERVENTIONAL
2018-03-01
2022-07-01
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Experimental group
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
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.
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.
Control group
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
Interval debulking surgery
Cytoreductive surgery (CRS) is performed after neoadjuvant chemotherapy.
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.
Interventions
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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.
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
70 Years
FEMALE
No
Sponsors
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Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
OTHER
Third Affiliated Hospital, Sun Yat-Sen University
OTHER
Henan Provincial People's Hospital
OTHER
Xiangya Hospital of Central South University
OTHER
The Third Xiangya Hospital of Central South University
OTHER
Peking University Cancer Hospital & Institute
OTHER
Peking University People's Hospital
OTHER
Cancer Hospital of Guizhou Province
OTHER
Chinese PLA General Hospital
OTHER
Hebei Medical University Fourth Hospital
OTHER
The Second Hospital of Hebei Medical University
OTHER
West China Second University Hospital
OTHER
Peking Union Medical College Hospital
OTHER
First Affiliated Hospital, Sun Yat-Sen University
OTHER
Henan Cancer Hospital
OTHER_GOV
Tianjin Medical University Cancer Institute and Hospital
OTHER
The Third Affiliated Hospital of Guangzhou Medical University
OTHER
Wuhan University
OTHER
RenJi Hospital
OTHER
Obstetrics & Gynecology Hospital of Fudan University
OTHER
Southern Medical University, China
OTHER
Fourth Affiliated Hospital of Guangxi Medical University
OTHER
Shandong Cancer Hospital and Institute
OTHER
Beijing Obstetrics and Gynecology Hospital
OTHER
Chongqing Cancer Institute
UNKNOWN
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
OTHER
Xinqiao Hospital of Chongqing
OTHER
Shu-Zhong Cui
OTHER
Responsible Party
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Shu-Zhong Cui
President of Affiliated Tumor Hospital of Guangzhou Medical University
Principal Investigators
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Shuzhong Cui, M.D
Role: STUDY_DIRECTOR
Affiliated Cancer Hospital & Institute of Guangzhou Medical University
Zhongqiu Lin, M.D
Role: STUDY_DIRECTOR
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Locations
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Department of Abdominal Surgery (Section 2), Affiliated Tumor Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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HIPEC-03
Identifier Type: -
Identifier Source: org_study_id
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