Efficacy of HIPEC Combined With Systemic Chemotherapy and CRS on Peritoneal Metastases From Gastric Cancer

Phase 3

• Conditions: Peritoneal Carcinomatosis; Gastric Cancer
• Interventions: Procedure: Systemic chemotherapy; Procedure: HIPEC with neoadjuvant chemotherapy

• Registration Number: NCT03179579
• Lead Sponsor: Shu-Zhong Cui

Brief Summary

This project is a multi-center, prospective, randomized controlled clinical observation the safety and efficacy that stage IV limited peritoneal metastasis of gastric cancer patients accept hyperthermic intraperitoneal chemotherapy plus neoadjuvant chemotherapy with CRS and systemic chemotherapy. With advanced-stage gastric patients of confined to the peritoneal as the research object, with median progression-free survival and overall survival, adverse events as the end points.

Detailed Description

Peritoneal metastases in gastric cancer are considered as terminal disease with poor prognosis, the median survival time of this kind of patients is less than 1 year and even worse in China. Recently, cytoreductive surgery (CRS) combined with hyperthermic intraperitoneal chemotherapy (HIPEC) has been suggested to improve survival in patients with peritoneal metastases from gastric cancer. Even though the REGATTA trial demonstrated that the removal of the primary tumor is not necessarily beneficial, the role of operation aiming at R0 resection combined with new regimens like HIPEC and new chemotherapeutic agents is still confusing. Neoadjuvant chemotherapy prolonged OS of patients received macroscopically radical (CC0) surgery. Compared to systemic chemotherapy, HIPEC promotes chemotherapy to penetrate deeper into the cancer tissue, which needed multicenter randomized clinical trials (RCTs) to comfirm. Therefore, we has conducting prospective phase III trial of HIPEC combined with systemic chemotherapy and CRS for gastric cancer with peritoneal metastasis.

Study Timeline

• Status Verified: 2017-06
• Study First Submitted: 2017-06-06
• Study First Submitted QC: 2017-06-06
• Last Update Submitted: 2017-06-06
• Study First Posted: 2017-06-07
• Last Update Posted: 2017-06-07
• Study Start: 2017-08-01
• Primary Completion: 2021-08-01
• Study Completion: 2022-08-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 88

Inclusion Criteria

1. Gastic adenocarcinoma is diagnosed by histological and cytological examination.

2. Peritoneal carcinomastosis of gastric cancer is diagnosed by laparotomy or laparoscopic exploration.

3. According to Sugarbaker's peritoneal cancer index (PCI), PCI score of participant is no more than 20.

4. 18 < Age < 70 year old

5. Expected survival > 3 months

6. Performance status: ECOG 0-1

7. Adequate bone marrow function Hb ≥9 g/dl (After correction in case of iron deficient anemia) WBC ≥ 3,500/mm3, Platelet ≥ 100,000/mm3

8. Adequate renal function Creatinine ≤ 1.5 mg/dl, and adequate hepatic function Bilirubin ≤ 1.5 mg/dl and AST and ALT ≤ 2.5×ULN

9. Voluntary participation after getting written informed consent.

Exclusion Criteria

1. Except for peritoneal carcinomatosis, gastric cancer concurrently metastasized to liver, lung, para-aortic lymph node and other distant organs.
2. Extensive adhesion in peritoneal cavity
3. Previous History of other malignancies
4. Poorly controlled disease e.g. atrial fibrillation, stenocardia, cardiac insufficiency, persistent hypertension despite medicinal treatment, ejection fraction<50%
5. Receiving other chemotherapy, radiotherapy or immunotherapy
6. Patients who are unsuitable candidates by doctor's decision
7. Without given written informed consent

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	Systemic chemotherapy	1. 3 cycles of neoadjuvant chemotherapy: S-1 40-60 mg/m\^2, d1-d14, Bid p.o.+ oxaliplatin 130 mg/m\^2, d1, IV, every 3 weeks 2. Cytoreductive surgery 3. 4-6 cycles of adjuvant chemotherapy: S-1 40-60 mg/m\^2, d1-d14, Bid p.o.+ oxaliplatin 130 mg/m\^2, d1, IV, every 3 weeks
Experimental group	HIPEC with neoadjuvant chemotherapy	1. HIPEC with paclitaxel 135 mg/m\^2+HIPEC with cisplatin 75 mg/m\^2±HIPEC with Raltitrexed 3 mg/m\^2 intraperitoneally in succession 2. 2 cycles of neoadjuvant chemotherapy: S-1 40-60 mg/m\^2, d1-d14, Bid p.o.+ oxaliplatin 130 mg/m\^2, d1, IV, every 3 weeks 3. Cytoreductive surgery 4. HIPEC with paclitaxel 135 mg/m\^2+HIPEC with cisplatin 75 mg/m\^2±HIPEC with Raltitrexed 3 mg/m\^2 intraperitoneally in succession 5. 4-6 cycles of adjuvant chemotherapy: S-1 40-60 mg/m\^2, d1-d14, Bid p.o.+ oxaliplatin 130 mg/m\^2, d1, IV, every 3 weeks

Primary Outcome Measures

Name	Time	Method
Median overall survival	3 years	assess median overall survival rate during 3 years in both study arms

Secondary Outcome Measures

Name	Time	Method
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).

Trial Locations

Locations (1)

Department of Abdominal Surgery (Section 2), Affiliated Tumor Hospital of Guangzhou Medical University; 🇨🇳 Guangzhou, Guangdong, China