Radical Gastrectomy With/Without HIPEC in Advanced Gastric Cancer Patients

Malignant Neoplasm of Stomach Clinical Trial

Official title:

Prospective Phase III Trial Using Radical Gastrectomy With/Without HIPEC in Advanced Gastric Cancer Patients Including Adenocarcinoma of the Esophagogastric Junction

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02381847
• Other study ID #: NDTHNanjingUMS
• Status: Recruiting
• Phase: Phase 3
• First received: February 28, 2015
• Last updated: March 4, 2015
• Start date: January 2015
• Est. completion date: March 2020

Study information

• Verified date: February 2015
• Source: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
• Contact: Meng Wang
• Phone: 86-13815890469
• Email: wangmeng001[@]263.net
• Is FDA regulated: No
• Health authority: China: National Health and Family Planning Commission
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: March 2020
• Est. primary completion date: March 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Malignant Neoplasm of Stomach
• Neoplasms
• Stomach Neoplasms

Intervention

Procedure:
• intraperitoneal chemoperfusion
HIPEC with cisplatin at the time of D2 radical surgery

Locations

Country	Name	City	State
China	Meng Wang	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	overall survival	overall survival [ Time Frame: Death or 2 years ]	24 months	No
Secondary	complication rate		30 days	Yes
Secondary	time to progress	follow up every 3 months till 24 months end of study	24 months	No
Secondary	time to distant metastasis	time to other distant metastases follow up every 3 months till 24 months	24 months	No