SP Intravenous Chemotherapy Versus SP by HIPEC in Stage Ⅲ Patients After D2 Gastrectomy

NCT ID: NCT02396498

Last Updated: 2015-03-24

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 270 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-04-30
• Study Completion Date: 2016-12-31

Brief Summary

The study is designed to assess the safety and efficacy of S-1 plus cisplatin hyperthermic intraperitoneal chemotherapy in stage Ⅲ patients after D2 gastrectomy

Detailed Description

The study is a randomized clinical trial，and subjects wuill be assigned two arms: SP Intravenous Chemotherapy or SP by HIPEC .After 8 cycles treatment,we assess the safety and efficacy.

Conditions

Stage Ⅲ Gastric Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

D2 radical gastrectomy+Systemic chemotherapy

8 cycles of systemic chemotherapy were performed for stage Ⅲ patients after D2 gastrectomy .Systemic chemotherapy(SP): Cisplatin: 60mg/m\^2, d1 , Intravenous infusion, 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.

Group Type: PLACEBO_COMPARATOR

No interventions assigned to this group

D2 radical gastrectomy+HIPEC

8 cycles of hyperthermic intraperitoneal chemotherapy (cisplatin) and S-1(oral) were performed after D2 radical gastrectomy. 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.

Group Type: EXPERIMENTAL

HIPEC

Intervention Type: DRUG

Using cisplatin in HIPEC plus oral S-1

Interventions

HIPEC

Using cisplatin in HIPEC plus oral S-1

Intervention Type: DRUG

Other Intervention Names

hyperthermic intraperitoneal chemoperfusion

Eligibility Criteria

Inclusion Criteria

• 18 ≤ age ≤ 70 years old
• Histologically diagnosed as stageⅢ gastric adenocarcinoma，and perform D2 radical gastrectomy，as well as have not received any Anti-tumor therapy：chemotherapy,biological treatment or molecular targeted 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

Exclusion Criteria

• History of severe hypersensitivity reactions to the ingredients of S-1 or Cisplatin
• Hemoglobin<90g/L
• 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
• Participate in other clinical trial before the start of this trial
• Patient compliance is bad or researchers believe that patients are not suitable for this treatment
• Known to have active hepatitis patients

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tang-Du Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Helong Zhang, Professor

Role: PRINCIPAL_INVESTIGATOR

Tang-Du Hospital

Locations

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

Xi'an, Shaanxi, China

Site Status: RECRUITING

Countries

China

Central Contacts

Helong Zhang, Professor

Role: CONTACT

cnxazhl@163.com

029-87777225

Facility Contacts

Lina Liu

Role: primary

tangduec@126.com

029-84777631

References

Liu L, Sun L, Zhang N, Liao CG, Su H, Min J, Song Y, Yang X, Huang X, Chen D, Chen Y, Zhang HW, Zhang H. A novel method of bedside hyperthermic intraperitoneal chemotherapy as adjuvant therapy for stage-III gastric cancer. Int J Hyperthermia. 2022;39(1):239-245. doi: 10.1080/02656736.2022.2028018.

Reference Type: DERIVED

PMID: 35100917 (View on PubMed)

Other Identifiers

TDCCC005

Identifier Type: -

Identifier Source: org_study_id