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

• Sponsor: Hokkaido Gastrointestinal Cancer Study Group (Other)
• Overall Status: Suspended
• CT.gov ID: NCT00209664
• Collaborator: (none)
• Enrollment: 40
• Location: 1
• Duration (Months): 59
• Patients Per Site Per Month: 0.7

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Gastric Cancer	Drug: irinotecan; Drug: S-1	Phase 2

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.

Study Design

• Study Type: Interventional
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Phase II Study of Oral S-1 Plus Irinotecan in Patients With Advanced Gastric Cancer: Hokkaido Gastrointestinal Cancer Study Group HGCSG0303
• Study Start Date: Jan 1, 2004
• Study Completion Date: Dec 1, 2008

Outcome Measures

Primary Outcome Measures

1. objective tumor response []

Secondary Outcome Measures

1. Response duration, time to progression, median survival time, and safety will also be assessed. []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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:

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hokkaido University Hospital	Sapporo	Hokkaido	Japan	060-8638

Sponsors and Collaborators

• Hokkaido Gastrointestinal Cancer Study Group

Investigators

• Study Chair: Yoshito Komatsu, MD, PhD, Hokkaido Gastrointestinal Cancer Study Group

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00209664
• Other Study ID Numbers: HGCSG0303
• First Posted: Sep 21, 2005
• Last Update Posted: Feb 2, 2006
• Last Verified: Jan 1, 2004

• Keywords provided by , ,: Irinotecan, S-1, Phase II, gastric cancer
• Additional relevant MeSH terms: Stomach Neoplasms; Irinotecan

Study Results

No Results Posted as of Feb 2, 2006