Sequential HIPEC of Oxaliplatin and Paclitaxel for Gastric Cancer Patients With Peritoneum Metastasis

Gastric Cancer Clinical Trial

— SHOP-G01  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01471132
• Other study ID #: HIPEC-GCOT
• Status: Recruiting
• Phase: Phase 2
• First received: November 1, 2011
• Last updated: December 6, 2012
• Start date: September 2011
• Est. completion date: September 2015

Study information

• Verified date: December 2012
• Source: Peking University
• Contact: Xiaojiang Wu
• Phone: 8601088196598
• Email: wu.xiaojiang[@]hotmail.com
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: September 2015
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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.

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gastric Cancer
• Metastases to Perineum
• Neoplasm Metastasis
• Stomach Neoplasms

Intervention

Drug:
• Oxaliplatin
Oxaliplatin 345mg/m2,43?,30mins
• Paclitaxel
Paclitaxel 260mg/m2,43?,30mins

Locations

Country	Name	City	State
China	Peking University Cancer Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Survival		every 3 month postoperation up to 24 months	No
Secondary	Safety	Number of Participants with Adverse Events(III or IV grades according to NCI-CTC)	every 3 month postoperation up to 24 months	Yes