Efficacy of HIPEC as NACT and Postoperative Chemotherapy in the Treatment of Advanced-Stage Epithelial Ovarian Cancer (EHNPCTASEOC)

Shu-Zhong Cui

Status and phase: Unknown; Phase 3

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

Treatments: Procedure: Interval debulking surgery; Procedure: Hyperthermic Intraperitoneal Chemotherapy; Drug: neoadjuvant chemotherapy; Drug: adjuvant chemotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT03180177

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 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.

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 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.

Enrollment: 263 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 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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263 participants in 2 patient groups

Experimental group

Experimental group

Description:

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

Treatment:

Drug: neoadjuvant chemotherapy

Procedure: Hyperthermic Intraperitoneal Chemotherapy

Drug: adjuvant chemotherapy

Procedure: Interval debulking surgery

Control group

Active Comparator group

Description:

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

Treatment:

Drug: neoadjuvant chemotherapy

Drug: adjuvant chemotherapy

Procedure: Interval debulking surgery