NCT00209664

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

Trial Health

33
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Trial recruitment is currently suspended
Enrollment
40

participants targeted

Target at P25-P50 for phase_2 gastric-cancer

Timeline
Completed

Started Jan 2004

Typical duration for phase_2 gastric-cancer

Geographic Reach
1 country

1 active site

Status
suspended

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2004

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 21, 2005

Completed
3.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
Last Updated

February 2, 2006

Status Verified

January 1, 2004

First QC Date

September 13, 2005

Last Update Submit

January 31, 2006

Conditions

Gastric Cancer

Keywords

Irinotecan, S-1, Phase II, gastric cancer

Outcome Measures

Primary Outcomes (1)

  • objective tumor response

Secondary Outcomes (1)

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

Interventions

irinotecanDRUG
S-1DRUG

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ・ 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hokkaido University Hospital

Sapporo, Hokkaido, 060-8638, Japan

Location

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

IrinotecanS 1 (combination)

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Intervention Hierarchy (Ancestors)

CamptothecinAlkaloidsHeterocyclic Compounds

Study Officials

  • Yoshito Komatsu, MD, PhD

    Hokkaido Gastrointestinal Cancer Study Group

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 21, 2005

Study Start

January 1, 2004

Study Completion

December 1, 2008

Last Updated

February 2, 2006

Record last verified: 2004-01

Locations

JP(1)