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| Name | Class |
|---|---|
| Tianjin Medical University Cancer Institute and Hospital | OTHER |
| Chinese PLA General Hospital | OTHER |
| Harbin Medical University | OTHER |
| Southern Medical University, China |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental group | Experimental |
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| Control group | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HIPEC with neoadjuvant chemotherapy | Procedure | HIPEC 3 times +NACT 2 cycles +CRS +HIPEC 3 times+ ACT 4-6 cycles |
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| Measure | Description | Time Frame |
|---|---|---|
| Median overall survival | assess median overall survival rate during 3 years in both study arms | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
10. Voluntary participation after getting written informed consent.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xian-Zi Yang, M.D | Contact | 8602066673666 | 7097359@qq.com | |
| Zhen Tang, M.M | Contact | 8602066673666 | tangzhentangmin@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Shu-Zhong Cui, M.D | Affiliated Cancer Hospital & Institute of Guangzhou Medical University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Abdominal Surgery (Section 2), Affiliated Tumor Hospital of Guangzhou Medical University | Guangzhou | Guangdong | 510095 | China |
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| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| D010534 | Peritoneal Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D000084262 | Hyperthermic Intraperitoneal Chemotherapy |
| D020360 | Neoadjuvant Therapy |
| ID | Term |
|---|---|
| D017024 | Chemotherapy, Adjuvant |
| D003131 | Combined Modality Therapy |
| D013812 | Therapeutics |
| D004358 | Drug Therapy |
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| OTHER |
| Guangdong Provincial People's Hospital | OTHER |
| Guangdong Provincial Hospital of Traditional Chinese Medicine | OTHER |
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| Systemic chemotherapy | Procedure | NACT 3 cycles +CRS +ACT 4-6 cycles |
|
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| D004066 |
| Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
| D000008 | Abdominal Neoplasms |
| D010532 | Peritoneal Diseases |
| D006979 |
| Hyperthermia, Induced |