Brief Title
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
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.
Study Phase
Phase 3
Study Type
Interventional
Primary Outcome
PR/SD rate
Secondary Outcome
Overall survival rate
Condition
Epithelial Ovarian Cancer
Intervention
Hyperthermic Intraperitoneal Chemotherapy
Study Arms / Comparison Groups
Experimental group
Description: Hyperthermic Intraperitoneal Chemotherapy (HIPEC) with paclitaxel 175 mg/m^2 and cisplatin 75 mg/m^2 intraperitoneally in succession 2 cycles of neoadjuvant chemotherapy: paclitaxel 175 mg/m^2 IV>3 hour+ carboplatin AUC = 5-6 IV>1 hour, every 3 weeks Interval debulking surgery Hyperthermic Intraperitoneal Chemotherapy (HIPEC) with paclitaxel 175 mg/m^2 and cisplatin 75 mg/m^2 intraperitoneally in succession 2 cycles of adjuvant chemotherapy: paclitaxel 175 mg/m^2 IV>3 hour+ carboplatin AUC = 5-6 IV>1 hour, every 3 weeks
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Procedure
Estimated Enrollment
263
Start Date
March 1, 2018
Completion Date
July 1, 2022
Primary Completion Date
July 1, 2021
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
Gender
Female
Ages
18 Years - 70 Years
Accepts Healthy Volunteers
No
Contacts
Shuzhong Cui, M.D, 0086-138-0251-3800, [email protected]
Location Countries
China
Location Countries
China
Administrative Informations
NCT ID
NCT03180177
Organization ID
HIPEC-03
Responsible Party
Sponsor-Investigator
Study Sponsor
Shu-Zhong Cui
Collaborators
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Study Sponsor
Shuzhong Cui, M.D, Study Director, Affiliated Cancer Hospital & Institute of Guangzhou Medical University
Verification Date
January 2018