- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02291211
S-1 Combined Cisplatin HIPEC for Palliative Operation Gastric Cancer of Stage IV Limited Peritoneal Metastasis
November 13, 2014 updated by: Tang-Du Hospital
Phase Ⅱ Study of S-1 Combined Cisplatin Hyperthermic Intraperitoneal Chemotherapy for Palliative Operation Gastric Cancer of Stage IV Limited Peritoneal Metastasis
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)
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Detailed Description
This project is a single-center, open clinical observation the safety and efficacy that stage IV limited peritoneal metastasis of gastric cancer patients accept S-1 plus hyperthermic intraperitoneal chemotherapy .
With advanced gastric patients of confined to the peritoneal after CRS as the research object, with progression-free survival and overall survival, adverse events as the end points.
Study Type
Interventional
Enrollment (Anticipated)
60
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Helong Zhang, Professor
- Phone Number: 029-87777225
- Email: cnxazhl@163.com
Study Locations
-
-
Shaanxi
-
Xi'an, Shaanxi, China, 029
- Recruiting
- IEC of Insititution for National Drug Clinical Trials,Tangdu Hospital,Fourth Military Medical University
-
Contact:
- Lina Liu
- Phone Number: 029-84777631
- Email: tangduec@126.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 18 ≤ 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
Exclusion Criteria:
- 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
- Have the history of allograft transplantation
- Conducted the autologous bone marrow transplantation in 4 weeks
- Participate in other clinical trial before the start of this trial in 4 weeks
- Patient compliance is bad or researchers believe that patients are not suitable for this treatment
- Known to have active hepatitis patients
- HER-2-positive patients (ICH3+or FISH+)
- History of severe hypersensitivity reactions to the ingredients of S-1 or Cisplatin
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: S-1 plus cisplatin HIPEC
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.
|
Using cisplatin in HIPEC plus oral S-1
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
PFS: Progression Free Survival
Time Frame: 2 years
|
from randomization to disease progression or death
|
2 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
OS: Overall Survival
Time Frame: 5 years
|
from randomization to death from any cause
|
5 years
|
Safety as measured by recording the subjects' Adverse Events from randomization to termination
Time Frame: 2 years
|
Record the subjects' AEs from randomization to termination
|
2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Helong Zhang, Professor, Tang-Du Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2014
Primary Completion (Anticipated)
October 1, 2016
Study Completion (Anticipated)
December 1, 2016
Study Registration Dates
First Submitted
November 11, 2014
First Submitted That Met QC Criteria
November 13, 2014
First Posted (Estimate)
November 14, 2014
Study Record Updates
Last Update Posted (Estimate)
November 14, 2014
Last Update Submitted That Met QC Criteria
November 13, 2014
Last Verified
September 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- TDCCC006
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Stage IV Gastric Cancer
-
National Cancer Institute (NCI)CompletedGastric Adenocarcinoma | Stage IV Gastric Cancer | Stage II Gastric Cancer | Stage III Gastric CancerUnited States
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)CompletedClinical Stage III Gastric Cancer AJCC v8 | Clinical Stage IV Gastric Cancer AJCC v8 | Metastatic Gastroesophageal Junction Adenocarcinoma | Unresectable Gastroesophageal Junction Adenocarcinoma | Gastroesophageal Junction Adenocarcinoma | Clinical Stage III Esophageal Adenocarcinoma AJCC v8 | Clinical Stage IV Esophageal Adenocarcinoma AJCC v8 and other conditionsUnited States
-
City of Hope Medical CenterRecruitingGastric Cancer | Gastric Adenocarcinoma | Gastric Cancer Stage IV | Gastric Neoplasm | Gastric Cancer Metastatic to Lung | Gastric Cancer Stage | Gastric Cancer Metastatic to Liver | Gastric Cancer Stage III | Gastric Cancer Stage II | Gastric Lesion | Gastric Cancer in Situ | Gastric Cancer Stage IIIB | Gastric... and other conditionsUnited States, Japan
-
University of ChicagoNational Cancer Institute (NCI)CompletedPancreatic Adenocarcinoma | Gastric Adenocarcinoma | Metastatic Pancreatic Adenocarcinoma | Malignant Gastrointestinal Neoplasm | Stage III Pancreatic Cancer | Stage IV Pancreatic Cancer | Gallbladder Carcinoma | Stage IV Gallbladder Cancer | Stage IV Gastric Cancer | Stage IIIA Gallbladder Cancer | Stage... and other conditionsUnited States
-
ECOG-ACRIN Cancer Research GroupNational Cancer Institute (NCI)RecruitingClinical Stage IV Gastric Cancer AJCC v8 | Metastatic Gastric Adenocarcinoma | Clinical Stage IV Esophageal Adenocarcinoma AJCC v8 | Clinical Stage IVA Esophageal Adenocarcinoma AJCC v8 | Clinical Stage IVA Gastric Cancer AJCC v8 | Clinical Stage IVB Esophageal Adenocarcinoma AJCC v8 | Clinical... and other conditionsUnited States
-
City of Hope Medical CenterActive, not recruitingAdenocarcinoma of the Gastroesophageal Junction | Stage IV Gastric Cancer | Recurrent Gastric Cancer | Diffuse Adenocarcinoma of the Stomach | Intestinal Adenocarcinoma of the Stomach | Mixed Adenocarcinoma of the Stomach | Stage IIIA Gastric Cancer | Stage IIIB Gastric Cancer | Stage IIIC Gastric Cancer and other conditionsUnited States
-
City of Hope Medical CenterNational Cancer Institute (NCI)CompletedRecurrent Pancreatic Cancer | Stage III Pancreatic Cancer | Stage IV Pancreatic Cancer | Stage IV Colon Cancer | Stage IV Rectal Cancer | Stage IV Gastric Cancer | Recurrent Colon Cancer | Recurrent Rectal Cancer | Recurrent Gastric Cancer | Stage III Colon Cancer | Stage III Gastric Cancer | Stage III Rectal...United States
-
National Cancer Institute (NCI)CompletedStage IV Gastric Cancer | Stage III Gastric CancerUnited States
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)RecruitingGastric Adenocarcinoma | Oligometastasis | Stage IV Esophageal Cancer AJCC v7 | Stage IV Gastric Cancer AJCC v7 | Stage IV Esophageal Adenocarcinoma AJCC v7United States
-
M.D. Anderson Cancer CenterRecruitingClinical Stage III Gastric Cancer AJCC v8 | Clinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8 | Clinical Stage IV Gastric Cancer AJCC v8 | Clinical Stage IV Gastroesophageal Junction Adenocarcinoma AJCC v8 | Metastatic Gastric Adenocarcinoma | Metastatic Gastroesophageal Junction... and other conditionsUnited States
Clinical Trials on S-1 plus cisplatin HIPEC
-
Kyungpook National University HospitalUnknownGastric CancerKorea, Republic of
-
Mianyang Central HospitalUnknownEsophageal Squamous Cell CarcinomaChina
-
Taiho Pharmaceutical Co., Ltd.Completed
-
Taiho Pharmaceutical Co., Ltd.Yakult Honsha Co., LTDCompletedGastric CancerJapan, Korea, Republic of
-
Gustave Roussy, Cancer Campus, Grand ParisUnknownColorectal Cancer With a Resected Minimal Synchronous PC | Ovarian Metastases | Tumour Rupture in the Abdominal CavityFrance
-
Sun Yat-sen UniversityUnknown
-
Peking University Cancer Hospital & InstituteRecruiting
-
Asan Medical CenterNational Cancer Center, Korea; Chonbuk National University Hospital; Samsung... and other collaboratorsCompletedAdvanced Gastric CancerKorea, Republic of
-
Taiho Oncology, Inc.Completed
-
Taiho Oncology, Inc.Completed