Clinical trial NCT03023436: Cytoreductive Surgery Combined With HIPEC and Chemotherapy for Gastric Cancer With Peritoneal Metastasis
Official title: Cytoreductive Surgery Combined With Hyperthermic Intraperitoneal Chemotherapy and Systemic Chemotherapy in Gastric Cancer With Regional Peritoneal Metastasis, a Multicenter and Single-arm Phase III Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Stomach Neoplasm
Keywords: Stomach Neoplasms
Cytoreduction Surgical Procedures
Lead sponsor: Nanfang Hospital, Southern Medical University
Sponsor class: OTHER
First posted: 2017-01-18
Enrollment: 220
Sex: ALL
Minimum age (years): 19
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study evaluates the survival benefit and safety of cytoreductive surgery(CRS) combined with HIPEC and chemotherapy in gastric cancer with peritoneal metastasis.

Detailed description: Peritoneal metastasis is one of the most frequent non-curable factors in advanced gastric cancer with poor prognosis, the median survival time of patients is less than 1 year and even worse in China. Recently, several new modalities have been developed and reported to improve survival, including the new chemotherapeutic agents, molecular targeting agents and hyperthermic intraperitoneal chemotherapy（HIPEC）.Still, the long-term outcomes based on multicenter randomized clinical trials (RCTs) are awaited.

The surgical approach to metastatic lesions has been proved to play a very crucial role in prolonging the survival of metastatic colorectal patients, which might be able to cure patients with the operation aiming at R0 resection. For patients with metastatic gastric cancer, surgical intervention of primary tumor and measurable metastatic lesion is technically feasible, while the survival benefit is controversial. 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 and new categories of classification for metastatic gastric cancer based on the treatment response is needed.

In order to evaluate the survival benefit and safety of cytoreductive surgery(CRS) and HIPEC before beginning chemotherapy in gastric cancer with peritoneal metastasis, patients who fulfill the inclusion and exclusion criteria will be recruited in this study and receive CRS, HIPEC and chemotherapy. Chemotherapy regimen based on cisplatin and fluorouracil(CF) are recommended. Patients are followed up for 2 years and the safety and survival outcome will be analyzed.

Eligibility criteria: Inclusion Criteria:

* Age from over 18 to under 75 years
* Histologically proven primary gastric adenocarcinoma confirmed pathologically by endoscopic biopsy
* Diagnosed with clinical T1-4N0-3M1（distant metastases confined to peritoneum, P1）according to the American Joint Committee on Cancer(AJCC) Cancer Staging Manual Seventh Edition by laparoscopic exploration
* Localized peritoneal metastasis with peritoneal cancer index(PCI) less than 20
* Resection of primary tumor and metastasis is anticipated to reach the CC0 status(no residual tumor )
* Performance status of 0 or 1 on Eastern Cooperative Oncology Group(ECOG) scale
* Written informed consent

Exclusion Criteria:

* Adenocarcinoma of esophageal-gastric junction(AEG) that requires thoracotomy
* Distant metastases not confined to peritoneum, including liver (H1), para-aortic lymphnode (stations 16a1 and/or b2), lung, brain, bone and other organs
* Histologically proven Human epidermal growth factor receptor 2(HER2)-neu overexpressing adenocarcinoma
* History of previous neoadjuvant chemotherapy , radiotherapy or clinical trial treatment within 3 months
* Contraindication for anesthesia, surgery, chemotherapeutic agents or HIPEC
* Women of child-bearing potential who are pregnant or breastfeeding
* History of prior/other malignancies within the 5 years prior to enrollment
* Cerebrovascular accident occurred within 6 months (myocardial infarction, unstable angina, cerebral infarction, or cerebral hemorrhage)
* History of continuous systematic administration of corticosteroids within one month
* Requirement of simultaneous surgery for other disease
* Emergency surgery due to complication (bleeding, obstruction or perforation) caused by gastric cancer
* FEV1\<50% of predicted values

Primary outcomes:
measure: 2-year Median survival time
timeFrame: 24 months
Secondary outcomes:
measure: 2-year overall survival rate
timeFrame: 24 months
measure: Progression free survival rate
timeFrame: 24 months
measure: Morbidity and mortality
timeFrame: 30 days; 24 months
Other outcomes:
measure: Quality of life(site-specific module for gastric cancer)
timeFrame: Every 6 months to 2 years
measure: Quality of life
timeFrame: Every 6 months to 2 years
measure: circulating tumor cell（CTC） alteration
timeFrame: Every 6 months to 2 years
measure: circulating tumor DNA（ctDNA）alteration
timeFrame: Every 3 months to 2 years
measure: Molecular biomarker alteration
timeFrame: Every 6 months to 2 years
Locations:
city: Beijing
country: China
facility: Peking University Cancer Hospital
state: Beijing
city: Fuzhou
country: China
facility: Fujian Provincial Hospital
state: Fujian
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: Cancer Center of Guangzhou Medical University
state: Guangdong
city: Guangzhou
country: China
facility: Zhujiang Hospital of Southern Medical University
state: Guangdong
city: Guangzhou
country: China
facility: Nanfang Hospital, Southern Medical University
state: Guangdong
city: Guangzhou
country: China
facility: The Third Affiliated Hospital of Sun Yat-sen University
state: Guangdong
city: Guangzhou
country: China
facility: The Sixth Affiliated Hospital of Sun Yat-sen University
state: Guangdong
city: Meizhou
country: China
facility: Meizhou People's Hospital
state: Guangdong
city: Zhongshan
country: China
facility: Zhongshan City People Hospital
state: Guangdong
city: Shanghai
country: China
facility: Zhongshan Hospital, Fudan University
state: Shanghai
city: Chengdu
country: China
facility: West China Hospital, Sichuan University
state: Sichuan
Study officials:
affiliation: Chinese Laparoscopic Gastrointestinal Surgery Study (CLASS) Group; Nanfang Hospital, Southern Medical University, China
name: Guoxin Li
role: PRINCIPAL_INVESTIGATOR
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