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

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Primary Purpose

Status

Suspended

Phase

Phase 2

Locations

Japan

Study Type

Interventional

Intervention

irinotecan

S-1

About this trial

This is an interventional treatment trial for Gastric Cancer focused on measuring Irinotecan, S-1, Phase II, gastric cancer

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: ・ Eligibility criteria Histological diagnosis of gastric adenocarcinoma. Measurable or assessable lesions. Age: 18 ~ 75 years. Performance Status (ECOG): 0 ~ 2. 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. No history of treatment with CPT-11 or S-1. No history of radiotherapy to the abdomen. Oral intake of S-1 is possible. 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: -

Sites / Locations

Hokkaido University Hospital

Outcomes

Primary Outcome Measures

objective tumor response

Secondary Outcome Measures

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

Full Information

NCT ID

NCT00209664

First Posted

September 13, 2005

Last Updated

January 31, 2006

Sponsor

Hokkaido Gastrointestinal Cancer Study Group

1. Study Identification

Unique Protocol Identification Number

NCT00209664

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2004

Overall Recruitment Status

Suspended

Study Start Date

January 2004 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

December 2008 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Hokkaido Gastrointestinal Cancer Study Group

4. Oversight

5. 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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Gastric Cancer

Keywords

Irinotecan, S-1, Phase II, gastric cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

40 (false)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

irinotecan

Intervention Type

Drug

Intervention Name(s)

S-1

Primary Outcome Measure Information:

Title

objective tumor response

Secondary Outcome Measure Information:

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria: ・ Eligibility criteria Histological diagnosis of gastric adenocarcinoma. Measurable or assessable lesions. Age: 18 ~ 75 years. Performance Status (ECOG): 0 ~ 2. 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. No history of treatment with CPT-11 or S-1. No history of radiotherapy to the abdomen. Oral intake of S-1 is possible. 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: -

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Yoshito Komatsu, MD, PhD

Organizational Affiliation

Hokkaido Gastrointestinal Cancer Study Group

Official's Role

Study Chair

Facility Information:

Facility Name

Hokkaido University Hospital

City

Sapporo

State/Province

Hokkaido

ZIP/Postal Code

060-8638

Country

Japan

Gastric Cancer

About this trial

Eligibility Criteria

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

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