NCT04522011

Brief Summary

Advanced gastric cancer has always been the focus and difficulty in the treatment of gastric cancer, and postoperative peritoneal recurrence is one of the key factors with poor prognosis. in recent years, hyperthermic intraperitoneal chemotherapy has been used in the treatment of advanced peritoneal metastases and achieved remarkable results. Existing studies have shown that postoperative hyperthermic intraperitoneal chemotherapy plays a certain role in reducing postoperative peritoneal recurrence of advanced gastric cancer. Our previous studies have shown that hyperthermic intraperitoneal chemotherapy adopted docetaxel combine oxaliplatin can also reduce the peritoneal recurrence of advanced gastric cancer. At present, there is a lack of comparison of the safety and efficacy of intraoperative and postoperative hyperthermic intraperitoneal chemotherapy. In this study, patients with advanced gastric cancer were selected by preoperative imaging, endoscopic ultrasonography and other examinations. The patients were randomly divided into group A: D1-2 radical gastrectomy plus hyperthermic intraperitoneal chemotherapy of docetaxel + oxaliplatin. Group B: D1-2 radical gastrectomy + postoperative hyperthermic intraperitoneal chemotherapy of docetaxel + oxaliplatin and group C: D1-2 radical radical gastrectomy .The three groups both proceed postoperative conventional adjuvant chemotherapy（SOX/XELOX）.The incidence of postoperative anastomotic leakage and other complications were collected, and the safety differences among the three groups were compared. The three-year overall survival (OS), disease-free survival (PFS), and disease-related mortality were evaluated and the long-term effects among the three groups were compared.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2021

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 17, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 21, 2020

Completed
4 months until next milestone

Study Start

First participant enrolled

January 1, 2021

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2023

Completed
Last Updated

August 21, 2020

Status Verified

August 1, 2020

Enrollment Period

2.2 years

First QC Date

August 17, 2020

Last Update Submit

August 19, 2020

Conditions

Stomach NeoplasmsHyperthermic Intraperitoneal Chemotherapy

Outcome Measures

Primary Outcomes (3)

  • Overall survival（0S）

    The length of time from either the date of diagnosis or the start of treatment for a disease, such as cancer, that patients diagnosed with the disease are still alive. In a clinical trial, measuring the overall survival is one way to see how well a new treatment works. Also called OS.

    1 month

  • Progression-free survival

    The length of time during and after the treatment of a disease, such as cancer, that a patient lives with the disease but it does not get worse. In a clinical trial, measuring the PFS is one way to see how well a new treatment works. Also called progression-free survival.

    1 month

  • The incidence of postoperative complications

    The incidence of medical problems that occurs after surgery

    through study completion, an average of 1 month

Study Arms (3)

Group A

D1/2 radical gastrectomy combines intraoperative hyperthermic intraperitoneal chemotherapy with docetaxel + oxaliplatin

Other: intraoperative or postoperative hyperthermic intraperitoneal chemotherapy

Group B

D1/2 radical gastrectomy combines postoperative hyperthermic intraperitoneal chemotherapy with docetaxel + oxaliplatin

Other: intraoperative or postoperative hyperthermic intraperitoneal chemotherapy

Group

without hyperthermic intraperitoneal chemotherapy

Interventions

intraoperative or postoperative hyperthermic intraperitoneal chemotherapyOTHER

Intraoperative hyperthermic intraperitoneal chemotherapy：Use docetaxel + oxaliplatin Intraoperately.(Docetaxel 30mg/m2 + oxaliplatin 30mg/m2), perfusion at 43 ℃ for 1 hour

Group AGroup B

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients who was diagnosed with gastric adenocarcinoma by pathology in the first affiliated Hospital of Jiaotong University since November 2019.

You may qualify if:

  • Patients with gastric adenocarcinoma diagnosed pathologically from 18 to 65 years old.
  • Transthoracic and abdominal contrast-enhanced CT and endoscopic ultrasonography were diagnosed as cT3 / T4 N (+).
  • There are no obvious surgical taboos in cardiopulmonary function and blood coagulation.
  • Ability to provide informed consent

You may not qualify if:

  • Physical strength score ZPS \> = 2.
  • Distant metastasis
  • Pregnant or lactating.
  • Have serious chronic diseases (hypertension, diabetes, etc.).
  • Allergic to chemotherapeutic drugs.
  • Poor compliance

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kun Zhu

Xi'an, Shannxi, 710061, China

Location

Related Publications (7)

  • Yu J, Huang C, Sun Y, Su X, Cao H, Hu J, Wang K, Suo J, Tao K, He X, Wei H, Ying M, Hu W, Du X, Hu Y, Liu H, Zheng C, Li P, Xie J, Liu F, Li Z, Zhao G, Yang K, Liu C, Li H, Chen P, Ji J, Li G; Chinese Laparoscopic Gastrointestinal Surgery Study (CLASS) Group. Effect of Laparoscopic vs Open Distal Gastrectomy on 3-Year Disease-Free Survival in Patients With Locally Advanced Gastric Cancer: The CLASS-01 Randomized Clinical Trial. JAMA. 2019 May 28;321(20):1983-1992. doi: 10.1001/jama.2019.5359.

    PMID: 31135850BACKGROUND

  • Yonemura Y, Elnemr A, Endou Y, Hirano M, Mizumoto A, Takao N, Ichinose M, Miura M, Li Y. Multidisciplinary therapy for treatment of patients with peritoneal carcinomatosis from gastric cancer. World J Gastrointest Oncol. 2010 Feb 15;2(2):85-97. doi: 10.4251/wjgo.v2.i2.85.

    PMID: 21160926BACKGROUND

  • Glehen O, Passot G, Villeneuve L, Vaudoyer D, Bin-Dorel S, Boschetti G, Piaton E, Garofalo A. GASTRICHIP: D2 resection and hyperthermic intraperitoneal chemotherapy in locally advanced gastric carcinoma: a randomized and multicenter phase III study. BMC Cancer. 2014 Mar 14;14:183. doi: 10.1186/1471-2407-14-183.

    PMID: 24628950BACKGROUND

  • Yonemura Y, Elnemr A, Endou Y, Ishibashi H, Mizumoto A, Miura M, Li Y. Effects of neoadjuvant intraperitoneal/systemic chemotherapy (bidirectional chemotherapy) for the treatment of patients with peritoneal metastasis from gastric cancer. Int J Surg Oncol. 2012;2012:148420. doi: 10.1155/2012/148420. Epub 2012 Jul 31.

    PMID: 22900159BACKGROUND

  • Roviello F, Caruso S, Marrelli D, Pedrazzani C, Neri A, De Stefano A, Pinto E. Treatment of peritoneal carcinomatosis with cytoreductive surgery and hyperthermic intraperitoneal chemotherapy: state of the art and future developments. Surg Oncol. 2011 Mar;20(1):e38-54. doi: 10.1016/j.suronc.2010.09.002. Epub 2010 Dec 15.

    PMID: 20888755BACKGROUND

  • Helm JH, Miura JT, Glenn JA, Marcus RK, Larrieux G, Jayakrishnan TT, Donahue AE, Gamblin TC, Turaga KK, Johnston FM. Cytoreductive surgery and hyperthermic intraperitoneal chemotherapy for malignant peritoneal mesothelioma: a systematic review and meta-analysis. Ann Surg Oncol. 2015 May;22(5):1686-93. doi: 10.1245/s10434-014-3978-x. Epub 2014 Aug 15.

    PMID: 25124472BACKGROUND

  • Bonnot PE, Piessen G, Kepenekian V, Decullier E, Pocard M, Meunier B, Bereder JM, Abboud K, Marchal F, Quenet F, Goere D, Msika S, Arvieux C, Pirro N, Wernert R, Rat P, Gagniere J, Lefevre JH, Courvoisier T, Kianmanesh R, Vaudoyer D, Rivoire M, Meeus P, Passot G, Glehen O; FREGAT and BIG-RENAPE Networks. Cytoreductive Surgery With or Without Hyperthermic Intraperitoneal Chemotherapy for Gastric Cancer With Peritoneal Metastases (CYTO-CHIP study): A Propensity Score Analysis. J Clin Oncol. 2019 Aug 10;37(23):2028-2040. doi: 10.1200/JCO.18.01688. Epub 2019 May 14.

    PMID: 31084544BACKGROUND

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Study Officials

  • Kun Sun

    First Affiliated Hospital Xi'an Jiaotong University

    STUDY CHAIR

Central Study Contacts

Kun Zhu

CONTACT

0086-18991232539dr.zhkun@mail.xjtu.edu.cn

Kun Zhu

CONTACT

0086-18991232539dangchengxue@mail.xjtu.edu.cn

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 17, 2020

First Posted

August 21, 2020

Study Start

January 1, 2021

Primary Completion

February 28, 2023

Study Completion

February 28, 2023

Last Updated

August 21, 2020

Record last verified: 2020-08

Locations

CN(1)