Clinical trial NCT02381847: Radical Gastrectomy With/Without HIPEC in Advanced Gastric Cancer Patients
Official title: Prospective Phase III Trial Using Radical Gastrectomy With/Without HIPEC in Advanced Gastric Cancer Patients Including Adenocarcinoma of the Esophagogastric Junction
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Malignant Neoplasm of Stomach
Keywords: gastric cancer
intraperitoneal chemoperfusion
Lead sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Sponsor class: OTHER
First posted: 2015-03-06
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Patients with histological proven advanced gastric cancer (including cancer of the esophagogastric junction (AEG) without evidence of distant metastases, who fulfill the inclusion and exclusion criteria, can be recruited in this study. There are two treatment groups (A and B). The D2 radical gastrectomy will be applied in both groups. Patients randomized into group B will be treated with an intraperitoneal (in the abdominal cavity) chemoperfusion with cisplatin(75mg/m2 max 150mg/m2 max 5L ). Patients randomized into group A will not accept intraperitoneal chemoperfusion. Patients in both groups receive 6 cycles of postoperative chemotherapy (SOX or XELOX) within 4-12 weeks after the surgical procedure and are followed up for 24 months.

Detailed description: The objective of the trial is to compare the treatment of patients with advanced gastric cancer without evidence of distant metastases treated with D2 radical gastrectomy and intraperitoneal chemoperfusion (HIPEC) and postoperative chemotherapy (Group B) and patients treated with D2 radical gastrectomy alone and postoperative chemotherapy (Group A).

The hypothesis of the trial is that D2 radical gastrectomy with intraperitoneal chemoperfusion (Group B) is superior to D2 radical gastrectomy (Group A) in terms of overall survival.

The trial is designed as a prospective, randomized, open, multicenter and parallel group study.

Eligibility criteria: Inclusion Criteria:

* Histological proved diagnosis of peritoneal metastasized gastric cancer including carcinoma of the AEG.
* No evidence of distant metastases
* preoperative examination (CT/MRI) demonstrated resectable gastricc cancer with T3-T4 stage
* Written informed consent is obtained prior to commencement of trial treatment

Exclusion Criteria:

* Any previous chemotherapy or radiotherapy, and any investigational treatment for gastric cancer
* Active systemic infections
* Patients with known interstitial lung disease with New York Heart Association classification \> 2
* Serious cardiac dysrhythmia or condition, New York Heart Association classification of III or IV, congestive cardiac failure
* cardiac arrhythmia
* Inadequate renal function at the beginning of the trial, defined as GFR less than \<60 ml/min
* Inadequate liver function at the beginning of the trial, defined as Bilirubin \>1.5 times ULN
* Inadequate bone marrow function at the beginning of the trial, defined as platelet count less than \<150 GPT/L or neutrophil granulocyte count less than \<1.5 GPT/
* Active vaccination within 6 weeks prior to randomisation
* Active hepatitis B or C infection
* Female patients who are pregnant or breast feeding
* Missing of capacity to contract
* contraindication to the drugs which are used in the trial
* Participation in another therapeutic clinical trial

Primary outcomes:
measure: overall survival
timeFrame: 24 months
Secondary outcomes:
measure: complication rate
timeFrame: 30 days
measure: time to progress
timeFrame: 24 months
measure: time to distant metastasis
timeFrame: 24 months
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Meng Wang
state: Jiangsu
Study officials:
affiliation: China Health Ministry
name: Wenxian Guan
role: PRINCIPAL_INVESTIGATOR
References: