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

Gastric Cancer Clinical Trial

Official title:

A Phase III Study of Hyperthermic Intraperitoneal Chemotherapy (HIPEC) Combined With Systemic Chemotherapy And Cytoreductive Surgery (CRS) in the Treatment of Peritoneal Carcinomatosis From Gastric Cancer

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03179579
• Other study ID #: HIPEC-02
• Status: Not yet recruiting
• Phase: Phase 3
• First received: June 6, 2017
• Last updated: June 6, 2017
• Start date: August 1, 2017
• Est. completion date: August 1, 2022

Study information

• Verified date: June 2017
• Source: Affiliated Tumor Hospital of Guangzhou Medical University
• Contact: Xian-Zi Yang, M.D
• Phone: 8602066673666
• Email: 7097359[@]qq.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 88
• Est. completion date: August 1, 2022
• Est. primary completion date: August 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Gastric Cancer
• Peritoneal Carcinomatosis
• Stomach Neoplasms

Intervention

Procedure:
• HIPEC with neoadjuvant chemotherapy
HIPEC 3 times +NACT 2 cycles +CRS +HIPEC 3 times+ ACT 4-6 cycles
• Systemic chemotherapy
NACT 3 cycles +CRS +ACT 4-6 cycles

Locations

Country	Name	City	State
China	Department of Abdominal Surgery (Section 2), Affiliated Tumor Hospital of Guangzhou Medical University	Guangzhou	Guangdong

Sponsors (7)

Lead Sponsor	Collaborator
Shu-Zhong Cui	Chinese PLA General Hospital, Guangdong General Hospital, Guangdong Provincial Hospital of Traditional Chinese Medicine, Harbin Medical University, Southern Medical University, China, Tianjin Medical University Cancer Institute and Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Median overall survival	assess median overall survival rate during 3 years in both study arms	3 years
Secondary	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).	Through study completion, an average of 1 year.