Phase II Study of Oral S-1 Plus Irinotecan in Patients With Advanced Gastric Cancer

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

Status

Suspended

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00209664

Enrollment

Registered

2005-09-21

Start date

2004-01-31

Completion date

2008-12-31

Last updated

2006-02-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastric Cancer

Keywords

Irinotecan, S-1, Phase II, gastric cancer

Brief 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

Detailed 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.

Interventions

DRUGirinotecan

DRUGS-1

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
objective tumor response	—

Secondary

Measure	Time frame
Response duration, time to progression, median survival time, and safety will also be assessed.	—

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026