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

Shu-Zhong Cui88 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Gastric Cancer Peritoneal Carcinomatosis

Interventions

HIPEC with neoadjuvant chemotherapyPROCEDURE

HIPEC 3 times +NACT 2 cycles +CRS +HIPEC 3 times+ ACT 4-6 cycles

Systemic chemotherapyPROCEDURE

NACT 3 cycles +CRS +ACT 4-6 cycles

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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 10\. 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

Locations (1)

Department of Abdominal Surgery (Section 2), Affiliated Tumor Hospital of Guangzhou Medical University

Guangzhou, Guangdong, China

Outcomes

Primary Outcomes

Median overall survival

assess median overall survival rate during 3 years in both study arms

Time frame: 3 years

Secondary Outcomes

Risk factors for morbidity and mortality

determine percent of patients wtih Grade I-IV adverse events according to NCI criteria, Common Terminology Criteria for AE (CTCAE 4.0).

Time frame: Through study completion, an average of 1 year.

Central Contacts

Xian-Zi Yang, M.D

CONTACT

8602066673666 7097359@qq.com

Zhen Tang, M.M

CONTACT

8602066673666 tangzhentangmin@163.com

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.