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Phase II Study of Oral S-1 Plus Irinotecan in Patients With Advanced Gastric Cancer: Hokkaido Gastrointestinal Cancer Study Group HGCSG0303


Phase 2
18 Years
75 Years
Not Enrolling
Both
Gastric Cancer

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Trial Information

Phase II Study of Oral S-1 Plus Irinotecan in Patients With Advanced Gastric Cancer: Hokkaido Gastrointestinal Cancer Study Group HGCSG0303


A multicenter Open-label, single-arm, phase II clinical trial is conducted on patients with
histological stage IV gastric cancer given irinotecan plus S-1. The usefulness of this
regimens as 1st line therapy for gastric cancer was evaluated by the disease-free survival
rate (DFR), overall survival rate (OS), incidence and severity of adverse event.


Inclusion Criteria:



・ Eligibility criteria

1. Histological diagnosis of gastric adenocarcinoma.

2. Measurable or assessable lesions.

3. Age: 18 ~ 75 years.

4. Performance Status (ECOG): 0 ~ 2.

5. No prior chemotherapy or only one regimen of previous chemotherapy (with a washout
period >4 weeks after the final day of the previous therapy). Adjuvant chemotherapy
is not defined as previous therapy.

6. No history of treatment with CPT-11 or S-1.

7. No history of radiotherapy to the abdomen.

8. Oral intake of S-1 is possible.

9. Adequate function of major organs (bone marrow, heart, lungs, liver etc.). WBC
3,500/mm3 and 12,000/mm3. Hb 10.0 g/dl. Platelet count 100,000/mm3. GOT and GPT
2.5times the upper limit of normal (excluding liver metastasis). T-Bil 2.0mg/dl.
Creatinine <1.5 mg/dl (but if it is 1.0 ~ 1.5 mg/dl, the dose of S-1 can be
decreased according to the dose reduction criteria to allow registration in the
trial). Normal ECG (not considering clinically unimportant arrhythmias and ischemic
changes). (10) Predicted survival for >3 months.

(11) Able to give written informed consent

Exclusion Criteria:

-

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

objective tumor response

Principal Investigator

Yoshito Komatsu, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Hokkaido Gastrointestinal Cancer Study Group

Authority:

Japan: Ministry of Health, Labor and Welfare

Study ID:

HGCSG0303

NCT ID:

NCT00209664

Start Date:

January 2004

Completion Date:

December 2008

Related Keywords:

  • Gastric Cancer
  • Irinotecan, S-1, Phase II, gastric cancer
  • Stomach Neoplasms
  • Gastrointestinal Neoplasms

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