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

Primary Purpose

Gastric Cancer

Status

Unknown status

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

HIPEC,Chemotherapy AND surgery

About this trial

This is an interventional treatment trial for Gastric Cancer focused on measuring chemotherapy, surgery, Surgically-Created Resection Cavity, Adverse Reaction to Drug

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Zhejiang Cancer HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

HIPEC,Chemotherapy AND surgery

Arm Description

surgical exploration,if PCI<20,then we perform this study 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(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

Outcomes

Primary Outcome Measures

R0 resection

the rate of R0 resection

Secondary Outcome Measures

Adverse Events

Number and degree of Adverse Events

Overall survival time

the overall survival time

Full Information

NCT ID

NCT02549911

First Posted

September 7, 2015

Last Updated

September 14, 2015

Sponsor

Zhejiang Cancer Hospital

1. Study Identification

Unique Protocol Identification Number

NCT02549911

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2015

Overall Recruitment Status

Unknown status

Study Start Date

September 2015 (undefined)

Primary Completion Date

September 2016 (Anticipated)

Study Completion Date

September 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Zhejiang Cancer Hospital

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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

Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Gastric Cancer

Keywords

chemotherapy, surgery, Surgically-Created Resection Cavity, Adverse Reaction to Drug

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

HIPEC,Chemotherapy AND surgery

Arm Type

Experimental

Arm Description

Intervention Type

Other

Intervention Name(s)

HIPEC,Chemotherapy AND surgery

Intervention Description

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

Primary Outcome Measure Information:

Title

R0 resection

Description

the rate of R0 resection

Time Frame

3 months

Secondary Outcome Measure Information:

Title

Adverse Events

Description

Number and degree of Adverse Events

Time Frame

6 months

Title

Overall survival time

Description

the overall survival time

Time Frame

3 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Yian Du, MD

Phone

86-571-88128031

ypfzmu@163.com

First Name & Middle Initial & Last Name or Official Title & Degree

Pengfei Yu, MD

Phone

86-571-88128031

ypfzmu@163.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Yian Du, MD

Organizational Affiliation

Zhejiang Cancer Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Zhejiang Cancer Hospital

City

Hangzhou

State/Province

Zhejiang

ZIP/Postal Code

310022

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Yian Du, MD

Phone

86-571-88128031

ypfzmu@163.com

First Name & Middle Initial & Last Name & Degree

Pengfei Yu, MD

Phone

86-571-88128031

ypfzmu@163.com

First Name & Middle Initial & Last Name & Degree

Yian Du, MD

First Name & Middle Initial & Last Name & Degree

Pengfei Yu, MD

12. IPD Sharing Statement

Citations:

PubMed Identifier

25864884

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.

Results Reference

background

PubMed Identifier

25421766

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.

Results Reference

background

PubMed Identifier

25406023

Citation

Di Vita M, Cappellani A, Piccolo G, Zanghi A, Cavallaro A, Bertola G, Bolognese A, Facchini G, D'Aniello C, Di Francia R, Cardi 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.

Results Reference

background

PubMed Identifier

33198674

Citation

Yu P, Ye Z, Dai G, Zhang Y, Huang L, Du Y, Cheng X. Neoadjuvant systemic and hyperthermic intraperitoneal chemotherapy combined with cytoreductive surgery for gastric cancer patients with limited peritoneal metastasis: a prospective cohort study. BMC Cancer. 2020 Nov 16;20(1):1108. doi: 10.1186/s12885-020-07601-x.

Results Reference

derived

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

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