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

This study is currently recruiting participants.
Verified December 2012 by Peking University
Sponsor:
Information provided by (Responsible Party):
Jiafu Ji, Peking University
ClinicalTrials.gov Identifier:
NCT01471132
First received: November 1, 2011
Last updated: December 6, 2012
Last verified: December 2012
History of Changes
  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: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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:

U.S. FDA Resources

Further study details as provided by Peking University:

Primary Outcome Measures:
  • Overall Survival [ Time Frame: every 3 month postoperation up to 24 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety [ Time Frame: every 3 month postoperation up to 24 months ] [ Designated as safety issue: Yes ]
    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

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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 Peking University Cancer Hospital
  More Information

No publications provided

Responsible Party: Jiafu Ji, Director, Peking University
ClinicalTrials.gov Identifier: NCT01471132     History of Changes
Other Study ID Numbers: HIPEC-GCOT
Study First Received: November 1, 2011
Last Updated: December 6, 2012
Health Authority: China: Ethics Committee

Additional relevant MeSH terms:
Stomach Neoplasms
Neoplasm Metastasis
Neoplasms, Second Primary
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Neoplastic Processes
 Pathologic Processes
Oxaliplatin
Paclitaxel
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on May 16, 2013