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A Phase II Study of Neo-Adjuvant Chemotherapy in Locally Advanced Gastric Cancer

Phase 2
18 Years
Open (Enrolling)
Stage T3-4NxM0 Gastric Cancer

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Trial Information

A Phase II Study of Neo-Adjuvant Chemotherapy in Locally Advanced Gastric Cancer

Inclusion Criteria:

- Age greater than or equal 18 years. Histologic or cytologic diagnosis of
adenocarcinoma of stomach or gastric cardia (Siewart Classification Type III)
Preoperative Stage T3-4NxM0 by endoscopic ultrasound, CT of the abdomen/pelvis and
laparoscopy. (CT of the chest if it is a cardia lesion).

Absence of malignant cells in peritoneal lavage fluid during laparoscopic examination.

Patients must not have received any prior chemotherapy or hormonal therapy for the
treatment of gastric cancer.

Karnofsky performance status of 70 or higher. Estimated life expectancy of at least 12

Adequate organ function including the following:

- Bone marrow: White blood cells (WBC) greater than or equal 3.5 x 109/L Absolute
neutrophil (segmented and bands) count (ANC) greater than or equal 1.5 x 109/L Platelets
greater than or equal 100 x 109/L Haemoglobin greater than or equal 9g/dL

- Hepatic: Bilirubin within upper limit of normal (ULN), ALT or AST less than or equal
2.5x ULN Alkaline phosphatase less than or equal 2.5x ULN.

- Renal: creatinine less than or equal 1.5x ULN Signed informed consent by patient or
legal representative. Patients with reproductive potential must use an approved
contraceptive method if appropriate (eg, intrauterine device, birth control pills, or
barrier device) during and for three months after the study. Females with childbearing
potential must have a negative serum pregnancy test within 7 days prior to study

Exclusion Criteria:

- Prior treatment for locally advanced or metastatic gastric cancer. Any metastatic
disease will render patient ineligible according to AJCC staging manual. (See
appendix 11.4).

Treatment within the last 30 days with any investigational drug. Concurrent administration
of any other cancer therapy, including cytotoxic chemotherapy, hormonal therapy, and

Active infection that in the opinion of the investigator would compromise the patient's
ability to tolerate therapy.

Pregnancy. Breast-feeding. Serious concomitant disorders that would compromise the safety
of the patient or compromise the patient's ability to complete the study, at the
discretion of the investigator.

Poorly controlled diabetes mellitus with fasting blood sugar > 18 mM. Second primary
malignancy that is clinically detectable at the time of consideration for study

History of significant neurological or mental disorder, including seizures or dementia.

History of hypersensitivity to drugs formulated in Tween 80, the vehicle used for
commercial docetaxel formulations.

History of hypersensitivity to 5-fluorouracil

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Rate of complete pathological response

Principal Investigator

Alex Chang

Investigator Role:

Principal Investigator

Investigator Affiliation:

Johns Hopkins Medicine


United States: Institutional Review Board

Study ID:

JS 0420



Start Date:

January 2006

Completion Date:

Related Keywords:

  • Stage T3-4NxM0 Gastric Cancer
  • gastric cancer, neo-adjuvant chemotherapy
  • Stomach Neoplasms