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Clinical Trial Details — Status: Suspended

Administrative data

NCT number NCT00209664
Other study ID # HGCSG0303
Secondary ID
Status Suspended
Phase Phase 2
First received September 13, 2005
Last updated January 31, 2006
Start date January 2004
Est. completion date December 2008

Study information

Verified date January 2004
Source Hokkaido Gastrointestinal Cancer Study Group
Contact n/a
Is FDA regulated No
Health authority Japan: Ministry of Health, Labor and Welfare
Study type Interventional

Clinical Trial Summary

To assess the usefulness of irinotecan plus S-1 therapy based on the antitumor effect and survival period. by performing a phase II study of this combination in patients with inoperable or with postoperative gastric cancer


Description:

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.


Recruitment information / eligibility

Status Suspended
Enrollment 40
Est. completion date December 2008
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 75 Years
Eligibility 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:

Study Design

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


Related Conditions & MeSH terms


Intervention

Drug:
irinotecan

S-1


Locations

Country Name City State
Japan Hokkaido University Hospital Sapporo Hokkaido

Sponsors (1)

Lead Sponsor Collaborator
Hokkaido Gastrointestinal Cancer Study Group

Country where clinical trial is conducted

Japan, 

Outcome

Type Measure Description Time frame Safety issue
Primary objective tumor response
Secondary Response duration, time to progression, median survival time, and safety will also be assessed.
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