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

NCT02396498 | Unknown Phase 3 DMC

• 1 other identifier: TDCCC005
• Study Type: interventional
• Target: 270
• Locations: 1 country
• Sites: 1

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

Conditions

Stage Ⅲ Gastric Cancer

Outcome Measures

Primary Outcomes (1)

• DFS: Disease-Free Survival

  from the date of random to the date of recurrence or death for disease progression.

  2 years

Secondary Outcomes (3)

• OS: Overall Survival

  5 years

• The quality of life

  6 months

• Safety as measured by Adverse Events and Serious Adverse events In the process of the total treatment according CTCAE4.0

  6 months

Study Arms (2)

D2 radical gastrectomy+Systemic chemotherapy

PLACEBO COMPARATOR

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.

D2 radical gastrectomy+HIPEC

EXPERIMENTAL

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.

Drug: HIPEC

Interventions

HIPEC DRUG

Using cisplatin in HIPEC plus oral S-1

Also known as: hyperthermic intraperitoneal chemoperfusion

D2 radical gastrectomy+HIPEC

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≤ 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tang-Du Hospital: lead

Study Sites (1)

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

Xi'an, Shaanxi, 029, China

RECRUITING

Related Publications (1)

• 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.

  PMID: 35100917 DERIVED

MeSH Terms

Interventions

Hyperthermic Intraperitoneal Chemotherapy

Intervention Hierarchy (Ancestors)

Chemotherapy, Adjuvant; Combined Modality Therapy; Therapeutics; Drug Therapy; Hyperthermia, Induced

Study Officials

• Helong Zhang, Professor

  Tang-Du Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Helong Zhang, Professor

CONTACT

029-87777225; cnxazhl@163.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 11, 2014
• First Posted: March 24, 2015
• Study Start: April 1, 2014
• Primary Completion: April 1, 2016
• Study Completion: December 1, 2016
• Last Updated: March 24, 2015

Record last verified: 2015-03

Locations

CN (1)