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Sequential HIPEC of Oxaliplatin and Paclitaxel for Gastric Cancer Patients With Peritoneum Metastasis (SHOP-G01)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2012 by Jiafu Ji, Peking University.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01471132
First Posted: November 11, 2011
Last Update Posted: December 7, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Jiafu Ji, Peking University
  Purpose
The recurrence and metastasis of peritoneum is always the lethal consequence for gastric cancer patients, and there is no effective therapy until now. It has been reported by Dr.Fujimoto that intraperitoneal chemotherapy plus hyperthermic therapy, which called hyperthermic intraperitoneal chemotherapy (HIPEC), can eliminate and suppress the free cancer cells and tiny metastasis in abdomen. Refer to the experience of systematic chemotherapy, HIPEC with combination regimen would have a brighter prospect. In this study, the investigators would use Oxaliplatin and paclitaxel sequent as HIPEC regimen. The safety and overall survival would be observed and evaluated.

Condition Intervention Phase
Gastric Cancer Metastases to Perineum Drug: Oxaliplatin Drug: Paclitaxel Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 2 Study of Sequential Hyperthermic Intraperitoneal Chemotherapy of Oxaliplatin and Paclitaxel for Gastric Cancer Patients With Peritoneum Metastasis or Positive Free Cancer Cells in Abdomen

Resource links provided by NLM:


Further study details as provided by Jiafu Ji, Peking University:

Primary Outcome Measures:
  • Overall Survival [ Time Frame: every 3 month postoperation up to 24 months ]

Secondary Outcome Measures:
  • Safety [ Time Frame: every 3 month postoperation up to 24 months ]
    Number of Participants with Adverse Events(III or IV grades according to NCI-CTC)


Estimated Enrollment: 20
Study Start Date: September 2011
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: HIPEC Drug: Oxaliplatin
Oxaliplatin 345mg/m2,43℃,30mins
Drug: Paclitaxel
Paclitaxel 260mg/m2,43℃,30mins

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically proved gastric adenocarcinoma.
  • Peritoneum metastasis is observed or suspected by laparoscopy or radiologic examination,or free cancer cells are detected in peritoneal lavage liquid.
  • Potentially resectable gastric cancer.
  • ALT, AST < 80U/L; Total Bilirubin < 30μmol/L; WBC > 4x10^9/L; PLT > 100x10^9/L; Cr < 1.5 fold normal value.
  • ECOG 0-2 points.
  • Expected survival time longer than 3 months.
  • Informed consent.

Exclusion Criteria:

  • Recurrent gastric cancer.
  • Pregnant or lactating women.
  • Allergic to oxaliplatin or paclitaxel.
  • Abnormal liver/kidney function.
  • Serious heart/metabolic disease.
  Contacts and Locations
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): NCT01471132


Contacts
Contact: Xiaojiang Wu 8601088196598 wu.xiaojiang@hotmail.com

Locations
China, Beijing
Peking University Cancer Hospital Recruiting
Beijing, Beijing, China, 100142
Sponsors and Collaborators
Peking University
Investigators
Study Chair: Jiafu Ji Beijing Cancer Hospital
  More Information

Responsible Party: Jiafu Ji, Director, Peking University
ClinicalTrials.gov Identifier: NCT01471132     History of Changes
Other Study ID Numbers: HIPEC-GCOT
First Submitted: November 1, 2011
First Posted: November 11, 2011
Last Update Posted: December 7, 2012
Last Verified: December 2012

Additional relevant MeSH terms:
Neoplasm Metastasis
Stomach Neoplasms
Neoplastic Processes
Neoplasms
Pathologic Processes
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Paclitaxel
Oxaliplatin
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action