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Trial record 7 of 42 for:    Malignant Hyperthermia 5

Radical Gastrectomy and Hyperthermic Intraperitoneal Chemotherapy (HIPEC) in Locally Advanced Gastric Cancer

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ClinicalTrials.gov Identifier: NCT02528110
Recruitment Status : Not yet recruiting
First Posted : August 19, 2015
Last Update Posted : July 12, 2016
Sponsor:
Information provided by (Responsible Party):
Bin Xiong, MD, Wuhan University

Brief Summary:
The efficacy of HIPEC in prevention of local recurrence, distant metastasis or peritoneal metastasis in locally advanced gastric cancer is not definite. The hypothesis of the trial is that radical gastrectomy plus HIPEC is superior to only radical gastrectomy in terms of overall survival.

Condition or disease Intervention/treatment Phase
Malignant Neoplasm of Stomach Procedure: Hyperthermic intraperitoneal chemotherapy (HIPEC) Procedure: D2 radical gastrectomy Other: SOX postoperative chemotherapy Other: XELOX postoperative chemotherapy Phase 2

Detailed Description:

To determine the efficacy of HIPEC in the treatment of locally advanced gastric cancer, patients are randomized into HIPEC group and control group. In HIPEC group, the patients undergo radical gastrectomy with D2 lymphadenectomy and HIPEC with paclitaxel and 5-Fu. Patients in the control group just undergo radical gastrectomy with D2 lymphadenectomy. Patients in both groups receive 6 cycles of postoperative chemotherapy (SOX or XELOX) and are followed up for 5 years or until death.

The trial is designed as a prospective, randomized, open, multicenter and parallel group study.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study of Hyperthermic Intraperitoneal Chemotherapy (HIPEC) in the Treatment of Locally Advanced Gastric Cancer During Radical Gastrectomy
Study Start Date : August 2015
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : July 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Sham Comparator: Radical gastrectomy without HIPEC
Patients will be treated with a D2 radical gastrectomy for locally advanced gastric cancer and postoperative chemotherapy (SOX or XELOX)
Procedure: D2 radical gastrectomy
radical gastrectomy with D2 lymphadenectomy

Other: SOX postoperative chemotherapy
Oxaliplatin 130mg/m2 d1, Tegafur,Gimeracil and Oteracil Porassium Capsules 60mg, d1-14.

Other: XELOX postoperative chemotherapy
Oxaliplatin 130mg/m2 d1, Capecitabine 1000mg/m2 d1-14.

Experimental: Radical gastrectomy with HIPEC
Patients will be treated with a D2 radical gastrectomy for locally advanced gastric cancer and HIPEC with paclitaxel and 5-Fu and postoperative chemotherapy (SOX or XELOX)
Procedure: Hyperthermic intraperitoneal chemotherapy (HIPEC)
Normal saline 3000ml-4000ml, Paclitaxel 75mg/m2, 5-Fu 15mg/m2, 43°C, 60min.

Procedure: D2 radical gastrectomy
radical gastrectomy with D2 lymphadenectomy

Other: SOX postoperative chemotherapy
Oxaliplatin 130mg/m2 d1, Tegafur,Gimeracil and Oteracil Porassium Capsules 60mg, d1-14.

Other: XELOX postoperative chemotherapy
Oxaliplatin 130mg/m2 d1, Capecitabine 1000mg/m2 d1-14.




Primary Outcome Measures :
  1. overall survival [ Time Frame: 5 years ]
    From the date of surgery to the date of death or to the end of follow-up


Secondary Outcome Measures :
  1. progression-free survival [ Time Frame: 5 years ]
  2. distant metastasis rate [ Time Frame: 5 years ]
  3. peritoneal metastasis rate [ Time Frame: 5 years ]
  4. local recurrence rate [ Time Frame: 5 years ]
  5. complication rate [ Time Frame: 5 years ]


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histological proved diagnosis of locally advanced gastric cancer.
  • No evidence of distant metastases or peritoneal metastases.
  • Preoperative examination (CT/MRI) demonstrated resectable gastric cancer with T3-T4 stage.
  • Eligible for radical gastrectomy with D2 lymphadenectomy.
  • Have not received cytotoxic chemotherapy or radiotherapy.
  • Written informed consent is obtained prior to commencement of trial treatment.

Exclusion Criteria:

  • Existence of distant metastasis or peritoneal metastasis during surgery (M1).
  • Any previous chemotherapy or radiotherapy
  • Active systemic infections
  • Inadequate cardiac function, renal function, liver function or bone marrow function at the beginning of the trial.
  • Female patients who are pregnant or breast feeding

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Responsible Party: Bin Xiong, MD, Cancer Center of Wuhan University, Wuhan University
ClinicalTrials.gov Identifier: NCT02528110     History of Changes
Other Study ID Numbers: WuhanU_HIPEC
First Posted: August 19, 2015    Key Record Dates
Last Update Posted: July 12, 2016
Last Verified: July 2016
Additional relevant MeSH terms:
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Stomach Neoplasms
Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases