HIPEC, Intravenous Chemotherapy and Surgery for the Treatment of Advanced GC With Peritoneal Metastasis

Gastric Cancer Clinical Trial

Official title:

Hyperthermic Intraperitoneal Chemotherapy, Intravenous Chemotherapy Combined With Surgery for the Treatment of Advanced Gastric Cancer With Peritoneal Metastasis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02549911
• Other study ID #: HISA
• Status: Recruiting
• Phase: Phase 2
• First received: September 7, 2015
• Last updated: September 14, 2015
• Start date: September 2015
• Est. completion date: September 2017

Study information

• Verified date: September 2015
• Source: Zhejiang Cancer Hospital
• Contact: Yian Du, MD
• Phone: 86-571-88128031
• Email: ypfzmu[@]163.com
• Is FDA regulated: No
• Health authority: China: Food and Drug AdministrationUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

Explore the hyperthermic intraperitoneal chemotherapy (HIPEC) and intravenous chemotherapy for Creating the Operation Chance in advanced gastric cancer with peritoneal metastasis.

Description:

To assess the effectiveness and safety of Hyperthermic intraperitoneal chemotherapy, intravenous chemotherapy combined with surgery for the treatment of advanced gastric cancer with peritoneal metastasis,so as to further find out the optimal protocol for the Conversion therapy in the patients with advanced gastric cancer.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: September 2017
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

gastric cancer confirmed by endoscopic biopsy , and enhanced CT suspected to have peritoneal metastasis, including ascites, ovarian metastasis, omentum or peritoneal metastasis.

• Definitely diagnosed as above stage of stomach cancer before the operation via CT or MRI, ultrasonic endoscopy and blood tumor antigen test, or through the laparoscopy if necessary

• Untreated (e.g. radiotherapy, chemotherapy, target therapy and immunotherapy)

• ECOG (Eastern Cooperative Oncology Group) : 0~2

• Age: 18~75 years old

• Normal hemodynamic indices before the recruitment (including blood cell count and liver/kidney function). For example: WBC>4.0×109/L, NEU >1.5×109/L, PLT>100×109/L, BIL<1.5 times of upper limit of normal reference value, ALT and AST<2.5 times of upper limit of normal reference value, and CRE<1.2mg/dl

• Good cardiac function before the recruitment, no seizure of myocardial infarction in past half year, and controllable hypertension and other coronary heart diseases

• Not concomitant with other uncontrollable benign diseases before the recruitment (e.g. the infection in the lung, kidney and liver)

• Not participating in other study projects before and during the treatment

• Signed the Informed Consent Form

Exclusion Criteria:

• Not conforming to above inclusion criteria

• Distal metastasis to lung, liver, or para aortic lymph node metastasis

• Ever operation on the stomach

• Operation intolerance due to other systemic basic diseases

• Ever administered other drugs (including TCM drugs) before the recruitment, or no guarantee of progress according to the study requirement after the recruitment

• Allergy to the drugs in this protocol

• Pregnant or lactating women

• Women at childbearing age and of pregnancy desire during the study

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gastric Cancer
• Stomach Neoplasms

Intervention

Other:
• HIPEC,Chemotherapy AND surgery
HIPEC(RHL-2000B, Madain Medical Devices Co., Ltd., Jilin, China): Taxol (Paclitaxel Injection) 75 mg/m2, twice, within 72 hours after surgical exploration ; oral chemotherapy:S-1(Tegafur,Gimeracil and Oteracil Potassium Capsules): 80mg/m2, twice daily (after the breakfast and supper) for two weeks, and then suspend for one week. chemotherapy(PS for 3 cycles) : Taxol 150mg/m2,d1, S-1: 80mg/m2, twice daily (after the breakfast and supper) for two weeks, and then suspend for one week. surgery:Secondary surgical exploration:if PCI less than 20,then perform the cytoreductive surgery(resection of primary tumors and metastases ) after the surgery,HIPEC for two cycles,and PS chemotherapy for 3 cycles

Locations

Country	Name	City	State
China	Zhejiang Cancer Hospital	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Zhejiang Cancer Hospital

Country where clinical trial is conducted

China, 

References & Publications (3)

Di Vita M, Cappellani A, Piccolo G, Zanghì A, Cavallaro A, Bertola G, Bolognese A, Facchini G, D'Aniello C, Di Francia R, Cardì F, Berretta M. The role of HIPEC in the treatment of peritoneal carcinomatosis from gastric cancer: between lights and shadows. Anticancer Drugs. 2015 Feb;26(2):123-38. doi: 10.1097/CAD.0000000000000179. — View Citation

Wu X, Li Z, Li Z, Jia Y, Shan F, Ji X, Bu Z, Zhang L, Wu A, Ji J. Hyperthermic intraperitoneal chemotherapy plus simultaneous versus staged cytoreductive surgery for gastric cancer with occult peritoneal metastasis. J Surg Oncol. 2015 Jun;111(7):840-7. doi: 10.1002/jso.23889. Epub 2015 Apr 10. — View Citation

Xia W, Hu Y, Mou T, Chen T, Yu J, Li G. [Safety and efficacy of intraperitoneal hyperthermic perfusion chemotherapy following laparoscopic palliative resection for gastric cancer patients with peritoneal metastasis]. Zhonghua Wei Chang Wai Ke Za Zhi. 2014 Nov;17(11):1087-91. Chinese. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	R0 resection	the rate of R0 resection	3 months	Yes
Secondary	Adverse Events	Number and degree of Adverse Events	6 months	Yes
Secondary	Overall survival time	the overall survival time	3 years	Yes