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Hyperthermic Intraperitoneal Chemotherapy for Advanced Gastric Cancer With Peritoneal Metastatis

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ClinicalTrials.gov Identifier: NCT03604614
Recruitment Status : Recruiting
First Posted : July 27, 2018
Last Update Posted : July 27, 2018
Sponsor:
Information provided by (Responsible Party):
Wei Wang, Guangdong Provincial Hospital of Traditional Chinese Medicine

Brief Summary:
The incidence rate of gastric cancer is high in Southeast Asia, so is the mortality rate.Due to the lack of specific performance, about 5%-20% of patients have found peritoneal metastases at the time of first diagnosis.At present, clinical studies on HIPEC in the treatment of patients with advanced gastric cancer peritoneal metastasis are almost related to abdominal perfusion after laparoscopic gastrectomy.Herein, we conduct a single-centre randomized controlled trial to explore the safety and feasibility of laparoscopic exploration combined with HIPEC in the treatment of advanced gastric cancer with peritoneal metastasis.

Condition or disease Intervention/treatment Phase
Stage IV Gastric Cancer With Metastasis Hyperthermic Intraperitoneal Chemotherapy Exploratory Behavior Drug: Hyperthermic Intraperitoneal Chemotherapy Drug: Without Hyperthermic Intraperitoneal Chemotherapy Phase 2

Detailed Description:
Gastric cancer is one of the most common digestive tumors in the world.In China, advanced gastric cancer with severe local progression or distant metastasis is more common.Gastric cancer with peritoneal carcinomatosis has an extremely poor prognosis,with a median survival of less than 6 months.Hyperthermic Intraperitoneal Chemotherapy (HIPEC) is currently a treatment for malignant tumors in the abdominal cavity and prevents tumor recurrence and metastasis.Studies have shown that hyperthermic intraperitoneal perfusion chemotherapy (HIPEC) has good clinical efficacy in the prevention and treatment of peritoneal metastasis of gastric cancer and its associated malignant ascites.Therefore,we conduct a single-centre randomized controlled trial to explore the safety and feasibility of HIPEC in the treatment of advanced gastric cancer with peritoneal metastasis. The metahnism of HIPEC is taking advantage of the difference in temperature sensitivity between cancer cells and normal cells. Perfusion of the abdominal cavity with a chemical fluid of the appropriate temperature can be performed. Suitable high temperatures can directly kill tumor cells.It is generally believed that the optimal temperature for the treatment of tumors is 42.5°C to 44°C.In this study,we set the temperature 43°C. Paclitaxel is a novel broad-spectrum antitumor drug,which has a unique anti-cancer mechanism.We use Paclitaxel as peritoneal hyperthermic perfusion chemotherapy drugs.The chemotherapy is SOX(Teggio and Oxaliplatin),.The primary endpoint is PFS. Secondary endpoints are one-year OS、canversion rate and ascites assessment. A phase III study PHOENIX-GC trial had finished enrollment,and the conclusion was the median OS 17.7 and 15.2 months respectively for IP and SP.The primary analysis did not show the statistical superiority of the IP regimen.The sensitivity analysis IP considering the imbalance of ascites, suggested clinical efficacy of IP PTX in gastric cancer with peritoneal metastasis. For this reason,we conduct a trial to explore the safety and feasibility of HIPEC in the treatment of advanced gastric cancer with peritoneal metastasis.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 56 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Controlled Clinical Trial of Hyperthermic Intraperitoneal Chemotherapy for Advanced Gastric Cancer With Peritoneal Metastatis
Actual Study Start Date : June 1, 2017
Actual Primary Completion Date : August 24, 2017
Estimated Study Completion Date : August 24, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: HIPEC and chemotherapy
Hyperthermic Intraperitoneal Chemotherapy and SOX(Tiggio+Oxaliplatin )
Drug: Hyperthermic Intraperitoneal Chemotherapy
The investigators use Paclitaxel as peritoneal hyperthermic perfusion chemotherapy drugs,75mg/m2 for the first time,50mg/m2 for the second time and third time.The chemotherapy is SOX(Tiggio d1-d14 bid po and Oxaliplatin 130mg/m2 ivd d1 qd).The Tiggio dosage depends on the patient's body surface area, body surface area <1.25m2 40mg/time, 1.25-1.50m2 50mg/time, >1.50m2 60mg/time.

Sham Comparator: Without HIPEC
Without Hyperthermic Intraperitoneal Chemotherapy,Only SOX(Tiggio+Oxaliplatin )
Drug: Without Hyperthermic Intraperitoneal Chemotherapy
The chemotherapy is SOX(Tiggio d1-d14 bid po and Oxaliplatin 130mg/m2 ivd d1 qd).The Tiggio dosage depends on the patient's body surface area, body surface area <1.25m2 40mg/time, 1.25-1.50m2 50mg/time, >1.50m2 60mg/time.




Primary Outcome Measures :
  1. PFS [ Time Frame: From date of randomization until the date of first documented progression or date of death for tumor cause, whichever came first, assessed 7 months ]
    Progression-free survival


Secondary Outcome Measures :
  1. 1-year survival [ Time Frame: one year ]
    1-year overall survival rate

  2. Ascites assessment [ Time Frame: Intraoperative ]
    Ascites assessment during surgery

  3. Median survival [ Time Frame: From date of randomization until only 50% of individuals living for tumor cause, assessed 2 years ]
    Median Survival Time



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Primary gastric adenocarcinoma diagnosed pathologically by endoscopic biopsy;
  • Laparoscopic exploration of patients with advanced gastric adenocarcinoma of peritoneal metastasis;
  • Eastern Cooperative Oncology Group (ECOG): 0 ot 1;
  • American Society of Anesthesiologists (ASA) score: I to Ⅲ;
  • Patient informed consent。

Exclusion Criteria:

  • Pregnancy or female in suckling period;
  • Severe mental illness;
  • Preoperative imaging or intraoperative exploration reveals distant blood, liver, lung, and brain metastases;
  • 5 years of history of other malignant diseases;
  • A history of unstable angina or myocardial infarction within 6 months;
  • History of cerebral infarction or cerebral hemorrhage within 6 months;
  • A history of sustained systemic corticosteroid treatment within 1 month;
  • Emergency operation due to complication (bleeding, perforation or obstruction) caused by primary tumor;
  • Pulmonary function test FEV1 <predicted value 50%。

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03604614


Contacts
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Contact: Wei Wang, M.D., PH.D. +86-13922255515 wangwei16400@163.com

Locations
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China, Guangdong
Guangdong Province Hospital of Chinese Medicine, the Second Affiliated Hospital of Guangzhou University of Chinese Medicine Recruiting
Guangzhou, Guangdong, China, 510120
Contact: Wei Wang, M.D.,PH.D.    +86-13922255515    wangwei16400@163.com   
Contact: Wenjun Xiong, M.D.    +86-15920553177    xiongwj1988@163.com   
Principal Investigator: Wei Wang         
Principal Investigator: Jin Wan         
Principal Investigator: Wen jun Xiong         
Principal Investigator: De chang Diao         
Principal Investigator: Yan sheng Zheng         
Principal Investigator: Hong ming Li         
Principal Investigator: Yao bin He         
Principal Investigator: Li jie Luo         
Sponsors and Collaborators
Guangdong Provincial Hospital of Traditional Chinese Medicine
Investigators
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Principal Investigator: Wei Wang Guangdong Provincial Hospital of Traditional Chinese Medicine
Principal Investigator: Wenjun Xiong Guangdong Provincial Hospital of Traditional Chinese Medicine

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Responsible Party: Wei Wang, Wei Wang M.D., PhD.,Head of Gastroenterology, Principal Investigator, Clinical Professor, Guangdong Provincial Hospital of Traditional Chinese Medicine
ClinicalTrials.gov Identifier: NCT03604614     History of Changes
Other Study ID Numbers: GDPHCM-GI-03
First Posted: July 27, 2018    Key Record Dates
Last Update Posted: July 27, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: The data has not been published.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Wei Wang, Guangdong Provincial Hospital of Traditional Chinese Medicine:
peritoneal metastatis
Hyperthermic Intraperitoneal Chemotherapy
Advanced gastric adenocarcinoma

Additional relevant MeSH terms:
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Stomach Neoplasms
Fever
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Body Temperature Changes
Signs and Symptoms
Oxaliplatin
Antineoplastic Agents