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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


Phase 2
18 Years
70 Years
Open (Enrolling)
Both
Gastric Cancer, Metastases to Perineum

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Trial Information

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


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 < 30╬╝mol/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.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Overall Survival

Outcome Time Frame:

every 3 month postoperation up to 24 months

Safety Issue:

No

Principal Investigator

Jiafu Ji

Investigator Role:

Study Chair

Investigator Affiliation:

Peking University Cancer Hospital

Authority:

China: Ethics Committee

Study ID:

HIPEC-GCOT

NCT ID:

NCT01471132

Start Date:

September 2011

Completion Date:

September 2015

Related Keywords:

  • Gastric Cancer
  • Metastases to Perineum
  • Stomach Neoplasms
  • Neoplasm Metastasis
  • Neoplasms, Second Primary

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