## Protocol Section
### Identification Module
**NCT ID:** NCT03179579

**Brief Title:** Efficacy of HIPEC Combined With Systemic Chemotherapy and CRS on Peritoneal Metastases From Gastric Cancer

**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

#### Organization Study ID Info
**ID:** HIPEC-02
#### Organization
**Class:** OTHER
**Full Name:** Affiliated Cancer Hospital & Institute of Guangzhou Medical University
### Status Module
#### Completion Date
**Date:** 2022-08-01

**Type:** ESTIMATED

#### Expanded Access Info
**Last Known Status:** NOT_YET_RECRUITING
#### Last Update Post Date
**Date:** 2017-06-07

**Type:** ACTUAL

**Last Update Submit Date:** 2017-06-06

**Overall Status:** UNKNOWN

#### Primary Completion Date
**Date:** 2021-08-01

**Type:** ESTIMATED

#### Start Date
**Date:** 2017-08-01

**Type:** ESTIMATED

**Status Verified Date:** 2017-06

#### Study First Post Date
**Date:** 2017-06-07
**Type:** ACTUAL
**Study First Submit Date:** 2017-06-06
**Study First Submit QC Date:** 2017-06-06
### Sponsor Collaborators Module

#### Collaborators

**Class:** OTHER

**Name:** Tianjin Medical University Cancer Institute and Hospital

**Class:** OTHER

**Name:** Chinese PLA General Hospital

**Class:** OTHER

**Name:** Harbin Medical University

**Class:** OTHER

**Name:** Southern Medical University, China

**Class:** OTHER

**Name:** Guangdong Provincial People's Hospital

**Class:** OTHER

**Name:** Guangdong Provincial Hospital of Traditional Chinese Medicine

#### Lead Sponsor

**Class:** OTHER

**Name:** Shu-Zhong Cui

#### Responsible Party

**Investigator Affiliation:** Affiliated Cancer Hospital & Institute of Guangzhou Medical University

**Investigator Full Name:** Shu-Zhong Cui

**Investigator Title:** President of Affiliated Tumor Hospital of Guangzhou Medical

**Type:** SPONSOR_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** True

### Description Module

**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.

### Conditions Module

**Conditions:**

- Gastric Cancer

- Peritoneal Carcinomatosis

**Keywords:**

- Gastric Cancer

- Peritoneal Carcinomatosis

- Hyperthermic Intraperitoneal Chemotherapy

- Systemic Chemotherapy

- Cytoreductive Surgery

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** SINGLE

**Who Masked:**

- PARTICIPANT

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 88

**Type:** ESTIMATED

**Phases:**

- PHASE3

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** 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

**Intervention Names:**

- Procedure: HIPEC with neoadjuvant chemotherapy

**Label:** Experimental group

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** 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

**Intervention Names:**

- Procedure: Systemic chemotherapy

**Label:** Control group

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Experimental group

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

**Name:** HIPEC with neoadjuvant chemotherapy

**Other Names:**

- CRS with HIPEC and adjuvant cheomtherapy

**Type:** PROCEDURE

#### Intervention 2

**Arm Group Labels:**

- Control group

**Description:** NACT 3 cycles +CRS +ACT 4-6 cycles

**Name:** Systemic chemotherapy

**Other Names:**

- CRS with systemic chemotherpay

**Type:** PROCEDURE

### Outcomes Module

#### Primary Outcomes

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

**Measure:** Median overall survival

**Time Frame:** 3 years

#### Secondary Outcomes

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

**Measure:** Risk factors for morbidity and mortality

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

### Eligibility Module

**Eligibility Criteria:** 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

**Maximum Age:** 70 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** 7097359@qq.com

**Name:** Xian-Zi Yang, M.D

**Phone:** 8602066673666

**Role:** CONTACT

**Contact 2:**

**Email:** tangzhentangmin@163.com

**Name:** Zhen Tang, M.M

**Phone:** 8602066673666

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Guangzhou

**Contacts:**

***Contact 1:***

- **Email:** 7097359@qq.com

- **Name:** Xianzi Yang, M.D

- **Phone:** 8602066673666

- **Role:** CONTACT

***Contact 2:***

- **Name:** shuzhong cui, M.D

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** China

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

**State:** Guangdong

**Zip:** 510095

#### Overall Officials

**Official 1:**

**Affiliation:** Affiliated Cancer Hospital & Institute of Guangzhou Medical University

**Name:** Shu-Zhong Cui, M.D

**Role:** STUDY_CHAIR

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000005770

- Term: Gastrointestinal Neoplasms

- ID: D000004067

- Term: Digestive System Neoplasms

- ID: D000009371

- Term: Neoplasms by Site

- ID: D000009369

- Term: Neoplasms

- ID: D000004066

- Term: Digestive System Diseases

- ID: D000005767

- Term: Gastrointestinal Diseases

- ID: D000013272

- Term: Stomach Diseases

- ID: D000009375

- Term: Neoplasms, Glandular and Epithelial

- ID: D000009370

- Term: Neoplasms by Histologic Type

- ID: D000000008

- Term: Abdominal Neoplasms

- ID: D000010532

- Term: Peritoneal Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: BC06

- Name: Digestive System Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: BC26

- Name: Wounds and Injuries

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M16064

- Name: Stomach Neoplasms

- Relevance: HIGH

- As Found: Gastric Cancer

- ID: M12307

- Name: Neoplasm Metastasis

- Relevance: LOW

- As Found: Unknown

- ID: M2454

- Name: Hyperthermia

- Relevance: LOW

- As Found: Unknown

- ID: M8464

- Name: Fever

- Relevance: LOW

- As Found: Unknown

- ID: M5534

- Name: Carcinoma

- Relevance: HIGH

- As Found: Carcinomatosis

- ID: M13443

- Name: Peritoneal Neoplasms

- Relevance: HIGH

- As Found: Peritoneal Carcinomatosis

- ID: M8886

- Name: Gastrointestinal Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M7256

- Name: Digestive System Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M7255

- Name: Digestive System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M8883

- Name: Gastrointestinal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M16062

- Name: Stomach Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M12320

- Name: Neoplasms, Glandular and Epithelial

- Relevance: LOW

- As Found: Unknown

- ID: M12315

- Name: Neoplasms by Histologic Type

- Relevance: LOW

- As Found: Unknown

- ID: M7

- Name: Abdominal Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M13441

- Name: Peritoneal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: T5486

- Name: Stomach Cancer

- Relevance: HIGH

- As Found: Gastric Cancer

### Condition Browse Module - Meshes

- ID: D000013274

- Term: Stomach Neoplasms

- ID: D000002277

- Term: Carcinoma

- ID: D000010534

- Term: Peritoneal Neoplasms

### Intervention Browse Module - Browse Branches

- Abbrev: ANeo

- Name: Antineoplastic Agents

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M252094

- Name: Raltitrexed

- Relevance: LOW

- As Found: Unknown

- ID: M19537

- Name: Paclitaxel

- Relevance: LOW

- As Found: Unknown

- ID: M231

- Name: Albumin-Bound Paclitaxel

- Relevance: LOW

- As Found: Unknown

- ID: M6182

- Name: Cisplatin

- Relevance: LOW

- As Found: Unknown

- ID: M1674

- Name: Oxaliplatin

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-24
