Efficacy of HIPEC in the Treatment of Advanced-Stage Epithelial Ovarian Cancer After Cytoreductive Surgery (EHTASEOCCS)

Affiliated Cancer Hospital & Institute of Guangzhou Medical University

Status and phase: Unknown; Phase 3

Conditions: Epithelial Ovarian Cancer; Primary Peritoneal Carcinoma; Fallopian Tube Cancer

Treatments: Procedure: Hyperthermic Intraperitoneal Chemotherapy; Drug: adjuvant chemotherapy; Procedure: cytoreductive surgery

Study type: Interventional

Funder types: Other

Identifiers

NCT03373058

HIPEC-03

Details and patient eligibility

About

This project is a multi-center, prospective, randomized controlled clinical observation the safety and efficacy of hyperthermic intraperitoneal chemotherapy in the treatment of advanced-stage epithelial ovarian cancer after cytoreductive surgery. Median recurrence-free survival is the primary end points of this project.

Full 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 Fagotti score by laparoscopic exploration < 6 would benefit from primary cytoreductive surgery followed by postoperative chemotherapy, and are likely to attain optimal cytoreduction (residual lesion ≤ 1 cm).

Hyperthermia promotes chemotherapy to penetrate deeper into the cancer tissue. Therefore, hyperthermic intraperitoneal chemotherapy (HIPEC) as newly postoperative chemotherapy after primary cytoreductive surgery in the treatment of ovarian cancer could lead to higher response rate and better survival outcomes.

Enrollment: 310 estimated patients

Sex: Female

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Disease status primary epithelial ovarian cancer, tubal cancer, and primary peritoneal cancer (Stage III )
• Fagotti score by laparoscopic exploration < 6
• Residual tumor < 1cm after completion of cytoreductive 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
• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

310 participants in 2 patient groups

Experimental group

Experimental group

Description:

1. Cytoreductive surgery 2. Hyperthermic Intraperitoneal Chemotherapy (HIPEC) with Docetaxel 75 mg/m\^2 and cisplatin 75 mg/m\^2 intraperitoneally in succession 3. 6 cycles of adjuvant chemotherapy: paclitaxel 175 mg/m\^2 IV\>3 hour(Docetaxel 75 mg/m\^2, if paclitaxel is not available.)+ carboplatin AUC = 5-6 IV\>1 hour, every 3 weeks.

Treatment:

Procedure: cytoreductive surgery

Drug: adjuvant chemotherapy

Procedure: Hyperthermic Intraperitoneal Chemotherapy

Control group

Active Comparator group

Description:

1. Cytoreductive surgery 2. 6 cycles of adjuvant chemotherapy: paclitaxel 175 mg/m\^2 IV\>3 hour(Docetaxel 75 mg/m\^2, if paclitaxel is not available)+ carboplatin AUC = 5-6 IV\>1 hour, every 3 weeks.

Treatment:

Procedure: cytoreductive surgery

Drug: adjuvant chemotherapy