NCT02291211

Brief Summary

This study is designed to investigate the efficacy of S-1 plus cisplatin hyperthermic intraperitoneal chemotherapy for advanced gastric patients of gastric cytoreductive surgery (CRS)

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 P50-P75 for phase_2

Timeline
Completed

Started Sep 2014

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

September 1, 2014

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 11, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 14, 2014

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

November 14, 2014

Status Verified

September 1, 2014

Enrollment Period

2.1 years

First QC Date

November 11, 2014

Last Update Submit

November 13, 2014

Conditions

Stage IV Gastric Cancer

Outcome Measures

Primary Outcomes (1)

  • PFS: Progression Free Survival

    from randomization to disease progression or death

    2 years

Secondary Outcomes (2)

  • OS: Overall Survival

    5 years

  • Safety as measured by recording the subjects' Adverse Events from randomization to termination

    2 years

Study Arms (1)

S-1 plus cisplatin HIPEC

EXPERIMENTAL

8 cycles of hyperthermic intraperitoneal chemotherapy (cisplatin) and S-1(oral) were performed after palliative operation gastric cancer of stage IV limited peritoneal metastasis. HIPEC was conducted in d1 and d3: Normal saline 2000ml-5000ml, Cisplatin 60mg/m\^2, 43°C, 60min. every 3 weeks. S-1: 40-60mg/m\^2 bid, days 1-14, every 3 weeks.Subjects should be given maximum 8 cycles, or progression/intolerance.

Drug: S-1 plus cisplatin HIPEC

Interventions

S-1 plus cisplatin HIPECDRUG

Using cisplatin in HIPEC plus oral S-1

Also known as: hyperthermic intraperitoneal chemoperfusion
S-1 plus cisplatin HIPEC

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ≤ age ≤ 70 years old
  • Patients with histologically confirmed gastric cancer (adenocarcinoma), stage IV (limited to the abdominal cavity), accpeted palliative cytoreductive surgery and no prior chemotherapy, biological therapy or targeted anti-cancer therapy, etc.
  • The Eastern Cooperative Oncology Group (ECOG) status ≤ 2
  • Having given written informed consent prior to any procedure related to the study
  • Expected survival time ≥3 months

You may not qualify if:

  • Known to have abdominal viscera metastasis of gastric cancer patients
  • Inadequate hematopoietic function which is defined as below:
  • white blood cell (WBC) less than 3,500/mm\^3
  • absolute neutrophil count (ANC) less than 1,500/mm\^3
  • platelets less than 80,000/mm\^3
  • Inadequate hepatic or renal function which is defined as below:
  • serum bilirubin greater than 2 times the upper limit of normal range
  • alanine aminotransferase (ALT) or aspartate aminotransferase (AST) greater than 2.5 times the ULN if no demonstrable liver metastases or greater than 5 times the ULN in the presence of liver metastases
  • blood creatinine level greater than 1.5 times ULN,Creatinine clearance \< 60ml/min
  • Receiving a concomitant treatment with other fluoropyrimidine drug or flucytosine drug
  • Women who is pregnant or lactating or fertile women of child-bearing potential unless using a reliable and appropriate contraceptive method throughout the treatment period (Including male)
  • Psychiatric disorder or symptom that makes participation of the patient difficult
  • Myocardial infarction, existing serious or unstable angina, and patients with cardiac insufficiency in 6 months
  • Severe complication(s), e.g., paresis of intestines, ileus, radiographically confirmed interstitial pneumonitis or pulmonary fibrosis, glomerulonephritis ,renal failure, poorly-controlled diabetes
  • Known DPD deficiency
  • +7 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IEC of Insititution for National Drug Clinical Trials,Tangdu Hospital,Fourth Military Medical University

Xi'an, Shaanxi, 029, China

RECRUITING

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

S 1 (combination)

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Study Officials

  • Helong Zhang, Professor

    Tang-Du Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Helong Zhang, Professor

CONTACT

029-87777225cnxazhl@163.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 11, 2014

First Posted

November 14, 2014

Study Start

September 1, 2014

Primary Completion

October 1, 2016

Study Completion

December 1, 2016

Last Updated

November 14, 2014

Record last verified: 2014-09

Locations

CN(1)