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A Phase I Trial of Induction Chemotherapy and Chemoradiotherapy With TS-1 and Cisplatin (SP) as First-line Treatment in Patients With High Risk Advanced Gastric Cancer

Phase 1
20 Years
75 Years
Not Enrolling
Gastric Cancer

Thank you

Trial Information

A Phase I Trial of Induction Chemotherapy and Chemoradiotherapy With TS-1 and Cisplatin (SP) as First-line Treatment in Patients With High Risk Advanced Gastric Cancer

Inclusion Criteria:

- Histologically or cytologically documented gastric adenocarcinoma

- Patients must have unresectable disease or high-risk advanced tumor: borrmann type
IV, large borrmann type III (>8cm),locally extensive nodal disease (bulky N),locally
advanced (T4) tumors,esophageal invasion

- Age: 20 to 75

- ECOG PS: 0 or 1

- Patients with adequate organ function : Absolute neutrophil count > 1.5 x 109 / L,
Platelet count > 100 x 109 / L, Hemoglobin > 9 g/dL (by transfusion permitted),
Calculated creatinine clearance > 60 ml/min, Serum total bilirubin < 1.5 times upper
normal limit (UNL), Serum alanine transaminase (ALT) < 3 times UNL

- Signed informed consent

- Sexually active patients, in conjunction with their partner, must practice birth
control during therapy. Female patients in child-bearing age must have negative
pregnancy test.

- No other malignancies within the past 5 years except for curatively treated basal
cell carcinoma of the skin and/or in situ carcinoma of the cervix

- No prior or concurrent significant medical conditions, including any of the
following: Cerebrovascular disease within the past year/ Cardiovascular disease;
myocardial infarction within the past year, uncontrolled hypertension while receiving
chronic medication, unstable angina, New York Heart Association class II-IV
congestive heart failure, serious cardiac arrhythmia requiring medication/ Major
trauma, major surgery or open biopsy within the 28 days Serious nonhealing wound,
ulcer, or bone fracture/ Evidence of bleeding diathesis or coagulopathy/ Recent
history of any active gastrointestinal inflammatory condition

- No lack of physical integrity of the upper GI tract, malabsorption syndrome, or
inability to take oral medication

- No bleeding from primary tumor or gastrointestinal stenosis

- sufficient oral intake

- No prior surgery for gastric cancer except for endoscopic membrane resection (EMR)

- No known peripheral neuropathy ≥ 1

- No prior chemotherapy

- No prior radiotherapy

Exclusion Criteria:

- Other tumor type than adenocarcinoma

- Metastasis to the sites out of abdomen (liver or other hematogenous metastasis)

- Patients with definite ascites in pre-operative abdomen CT

- documented inoperable peritoneal seeding disease determined by exploratory laparotomy

- Past or concurrent history of neoplasm other than gastric cancer, except for
curatively treated non-melanoma skin cancer or in situ carcinoma of the cervix uteri

- Pregnant or lactating women, women of childbearing potential not employing adequate

- Other serious illness or medical conditions: History of significant neurologic or
psychiatric disorders including dementia or seizures/ Active uncontrolled infection/
Severe hypercalcemia of above 12 mg/dL uncontrolled with bisphosphonates/ Other
serious underlying medical conditions which could impair the ability of the patient
to participate in the study

- Concurrent treatment with corticosteroids (or equivalent) except as use for the
prophylactic medication regimen, treatment of acute hypersensitivity reactions, or
unless chronic treatment (initiated > 6 months prior to study entry) at low dose (<20
mg methyl prednisolone or equivalent)

- Concomitant or with a 4-week period administration of any other experimental drug
under investigation

- Concomitant chemotherapy, hormonal therapy, or immunotherapy

- Prior palliative surgery (open and closure, passage operation)

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label

Outcome Measure:

maximum tolerated dose

Outcome Time Frame:

about 7 weeks

Safety Issue:



South Korea: Korea Food and Drug Administration (KFDA)

Study ID:




Start Date:

December 2009

Completion Date:

January 2012

Related Keywords:

  • Gastric Cancer
  • Stomach Neoplasms