NCT02381847

Brief 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.

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
60

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jan 2015

Longer than P75 for phase_3

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

Study Start

First participant enrolled

January 1, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 28, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 6, 2015

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2020

Completed
Last Updated

March 6, 2015

Status Verified

February 1, 2015

Enrollment Period

2.2 years

First QC Date

February 28, 2015

Last Update Submit

March 4, 2015

Conditions

Malignant Neoplasm of Stomach

Keywords

gastric cancerintraperitoneal chemoperfusion

Outcome Measures

Primary Outcomes (1)

  • overall survival

    overall survival \[ Time Frame: Death or 2 years \]

    24 months

Secondary Outcomes (3)

  • complication rate

    30 days

  • time to progress

    24 months

  • time to distant metastasis

    24 months

Study Arms (2)

without HIPEC

NO INTERVENTION

Patients will be treated with a D2 radical gastrectomy for advanced gastric cancer and postoperative chemotherapy (SOX or XELOX).

with HIPEC

EXPERIMENTAL

Patients will be treated with a D2 radical gastrectomy for advanced gastric cancer and intraperitoneal chemoperfusion with cisplatin and postoperative chemotherapy as described for the control group. Cisplatin: 75mg/m2 (max 150mg/m2 max 5L )

Procedure: intraperitoneal chemoperfusion

Interventions

intraperitoneal chemoperfusionPROCEDURE

HIPEC with cisplatin at the time of D2 radical surgery

Also known as: HIPEC
with HIPEC

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Meng Wang

Nanjing, Jiangsu, 210000, China

RECRUITING

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Hyperthermic Intraperitoneal Chemotherapy

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Intervention Hierarchy (Ancestors)

Chemotherapy, AdjuvantCombined Modality TherapyTherapeuticsDrug TherapyHyperthermia, Induced

Study Officials

  • Wenxian Guan

    China Health Ministry

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Meng Wang

CONTACT

86-13815890469wangmeng001@263.net

Wenxian Guan

CONTACT

86-83106666-60931guan_wx@163.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dean of General Surgery Department, Nanjing Drum Tower Hospital

Study Record Dates

First Submitted

February 28, 2015

First Posted

March 6, 2015

Study Start

January 1, 2015

Primary Completion

March 1, 2017

Study Completion

March 1, 2020

Last Updated

March 6, 2015

Record last verified: 2015-02

Locations

CN(1)