Clinical trial NCT02356276: Efficacy of HIPEC in the Treatment of Locally Advanced Gastric Cancer After radIcal Gastrectomy With D2
Official title: A Phase III Study of Hyperthermic Intraperitoneal Chemotherapy in the Treatment of Locally Advanced Gastric Cancer After radIcal Gastrectomy With D2
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Gastric Cancer
Keywords: locally advanced gastric cancer
Hyperthermic Intraperitoneal Chemotherapy
radical gastrectomy with D2 lymphadenectomy
Lead sponsor: Affiliated Cancer Hospital & Institute of Guangzhou Medical University
Sponsor class: OTHER
Collaborators: name: Tianjin Medical University Cancer Institute and Hospital
name: Nanfang Hospital, Southern Medical University
name: Zhejiang Cancer Hospital
name: The Second Hospital of Hebei Medical University
name: Chinese PLA General Hospital
name: Henan Cancer Hospital
name: Harbin Medical University
name: Central South University
name: Guangdong Provincial People's Hospital
name: Wuhan Union Hospital, China
name: Sun Yat-sen University
name: Hebei Medical University Fourth Hospital
name: Guangdong Provincial Hospital of Traditional Chinese Medicine
First posted: 2015-02-05
Enrollment: 584
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: HIPEC-01 is a prospective, open, randomized multicenter phase III clinical study conducted in China. To determine the efficacy of hyperthermic intraperitoneal chemotherapy (HIPEC) in the treatment of locally advanced gastric cancer, patients are randomized into HIPEC group and control group. In HIPEC group, the patients undergo radical gastrectomy with D2 lymphadenectomy and HIPEC with paclitaxel and postoperative chemotherapy. Patients in the control group just undergo radical gastrectomy with D2 lymphadenectomy followed by postoperative chemotherapy. Patients in both groups receive 6-8 cycles of postoperative systemic chemotherapy (XELOX or SOX regimens) and are followed up for 5 years or until death.

Detailed description: Gastric cancer (GC) is the fourth most common cancer, and the second leading cause of cancer-related death worldwide. Advances in diagnostic and therapeutic approaches have achieved long-term survival for early GC. However, receiving perioperative/postoperative systemic chemotherapy and gastrectomy with D1-D2 lymph node dissection, 5-year survival rates of advanced gastric cancer remain under 30%. 40-60% of recurrences are peritoneal and/or locoregional. hyperthermic intraperitoneal chemotherapy (HIPEC) technique is increasingly used in the curative treatment of primary and digestive peritoneal carcinomatosis, in association with cytoreductive surgery. Theoretically, HIPEC eliminates free cancer cells that can be released into peritoneal cavity during the gastrectomy and prevents peritoneal carcinomatosis recurrences. The benefit of using HIPEC as an adjuvant treatment for advanced gastric cancer has been reported in several randomized studies and a meta-analysis. Surgical resection combined with HIPEC significantly reduces the peritoneal recurrences and improves the overall survival of GC patients. But there is not a prospective and randomized phase III clinical study of HIPEC in the treatment of locally advanced gastric cancer after radical surgery in China so far.

In order to evaluate the survival benefit and safety of radical surgery and HIPEC followed by postoperative chemotherapy in local advanced gastric cancer, patients who fulfill the inclusion and exclusion criteria will be recruited in this study and randomized to two treatment groups (HIPEC group and control group). In HIPEC group, the patients undergo radical gastrectomy with D2 lymphadenectomy and HIPEC with paclitaxel and postoperative chemotherapy. Patients in the control group just undergo radical gastrectomy with D2 lymphadenectomy followed by postoperative chemotherapy. Patients in both groups receive 6-8 cycles of postoperative systemic chemotherapy (XELOX or SOX regimens) . Patients are followed up for 5 years and the survival outcome will be analyzed.

Eligibility criteria: Inclusion Criteria:

* 18 \< age ≤ 70 years old
* Male or Non pregnant female
* The Eastern Cooperative Oncology Group (ECOG) status 0-1
* T3 or T4 gastric adenocarcinoma (visual determination according to AJCC 2010 7th edition)
* No distance metastasis, eligible for D2 lymphadenectomy
* Have not received cytotoxic chemotherapy, radiotherapy or immunotherapy
* White blood cells \> 4,000/mm3
* neutrophils ≥ 1,500/mm3
* platelets ≥ 100,000/mm3
* hemoglobin\>9g/l
* Alanine transaminase (ALT) and aspartate aminotransferase (AST) \< or = 2.5 times upper limit of nominal (ULN)
* total bilirubin (TBIL) \< 1.5 times ULN
* serum creatinine \< 1 times ULN
* Having given written informed consent prior to any procedure related to the study

Exclusion Criteria:

* Have other cancer within 5 years
* Existence of distance metastasis during surgey (M1)
* Prior malignant tumors with detectable signs of recurrence or distant metastasis
* Poorly controlled disease e.g. atrial fibrillation, stenocardia, cardiac insufficiency, persistent hypertension despite medicinal treatment, ejection fraction\<50%
* Epileptic seizures patients need medicine control
* Uncontroled mental disease or mental disorder
* Drug abuse or psychological or social factors affect the judgment of results
* Contraindication to any therapy contained in this regimen specific to the study
* Receiving other chemotherapy, radiotherapy or immunotherapy
* Without given written informed consent

Primary outcomes:
measure: 5-year overall survival
timeFrame: 5 years
Secondary outcomes:
measure: 5-year progression-free survival
timeFrame: 5 years
measure: liver metastatic rate
timeFrame: 5 years
measure: local recurrence rate
timeFrame: 5 years
measure: side effects
timeFrame: 5 years
Other outcomes:
measure: CEA mRNA expression of peritoneal lavage fluid
timeFrame: Through study completion, an average of 3 year
Locations:
city: Beijing
country: China
facility: Chinese PLA General Hospital
state: Beijing
city: Guangzhou
country: China
facility: Sun Yat-sen University Cancer Center
state: Guangdong
city: Guangzhou
country: China
facility: Guangdong General Hospital
state: Guangdong
city: Guangzhou
country: China
facility: Affiliated Tumor Hospital of Guangzhou Medical University
state: Guangdong
city: Guangzhou
country: China
facility: Guangdong Provincial Hospital of Traditional Chinese Medicine
state: Guangdong
city: Guangzhou
country: China
facility: Nanfang Hospital of Southern Medical University
state: Guangdong
city: Shijiazhuang
country: China
facility: The Second Hospital of Hebei Medical University
state: Hebei
city: Shijiazhuang
country: China
facility: Hebei Medical University Fourth Hospital
state: Hebei
city: Harbin
country: China
facility: Harbin Medical University Cancer Hospital
state: Heilongjiang
city: Zhengzhou
country: China
facility: Henan Cancer Hospital
state: Henan
city: Wuhan
country: China
facility: Wuhan Union Hospital, China
state: Hubei
city: Changsha
country: China
facility: The second Xiangya Hospital of Central South University
state: Hunan
city: Tianjin
country: China
facility: Tianjin Medical University Cancer Institute and Hospital
state: Tianjin
city: Hanzhou
country: China
facility: Zhejiang Cancer Hospital
state: Zhejiang
Study officials:
affiliation: Affiliated Tumor Hospital of Guangzhou Medical University Recruiting
name: shuzhong cui, M.D
role: STUDY_DIRECTOR
References: