NCT00134095

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as S-1 and irinotecan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Giving chemotherapy before surgery may shrink the tumor so that it can be completely removed. PURPOSE: This phase II trial is studying how well giving S-1 together with irinotecan works in treating patients who are undergoing surgery for locally advanced stomach cancer.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
70

participants targeted

Target at P50-P75 for phase_2 gastric-cancer

Geographic Reach
1 country

7 active sites

Status
unknown

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

September 1, 2004

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

August 22, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 24, 2005

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2008

Completed
Last Updated

September 17, 2013

Status Verified

January 1, 2010

Enrollment Period

3.9 years

First QC Date

August 22, 2005

Last Update Submit

September 16, 2013

Conditions

Gastric Cancer

Keywords

adenocarcinoma of the stomachstage II gastric cancerstage III gastric cancerstage IV gastric cancer

Outcome Measures

Primary Outcomes (6)

  • Tumor shrinkage

  • Historical tumor shrinkage

  • Overall survival

  • Progression-free survival

  • Median survival

  • Safety

Interventions

irinotecan hydrochlorideDRUG
tegafur-gimeracil-oteracil potassiumDRUG
adjuvant therapyPROCEDURE
conventional surgeryPROCEDURE
neoadjuvant therapyPROCEDURE

Eligibility Criteria

Age20 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically confirmed gastric adenocarcinoma * Locally advanced disease * Clinical stage T3-4, N0-3, M0 (according to the Japanese gastric cancer classification) * Planning to undergo curative surgery after neoadjuvant chemotherapy PATIENT CHARACTERISTICS: Age * 20 to 75 Performance status * ECOG 0-1 Life expectancy * Not specified Hematopoietic * WBC 4,000-12,000/mm\^3 * Granulocyte count ≥ 2,000/mm\^3 * Platelet count ≥ 100,000/mm\^3 * Hemoglobin ≥ 9.0 g/dL Hepatic * AST and ALT ≤ 100 U/L * Bilirubin ≤ 1.5 mg/dL Renal * Creatinine normal OR * Creatinine clearance ≥ 50 mL/min Pulmonary * PaO\_2 \> 60 mm Hg on room air Other * Able to swallow oral medication PRIOR CONCURRENT THERAPY: Biologic therapy * No prior biologic therapy for gastric cancer Chemotherapy * No prior chemotherapy for gastric cancer Endocrine therapy * No prior endocrine therapy for gastric cancer Radiotherapy * No prior radiotherapy for gastric cancer Surgery * No prior surgery for gastric cancer Other * No other prior therapy for gastric cancer

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (7)

Yamamoto Kumiai General Hospital

Noshiro, Akita, 016-0014, Japan

Location

Fukushima Medical University Hospital

Fukushima, Fukushima, 960-1295, Japan

Location

Asahikawa Kosei General Hospital

Asahikawa, Hokkaido, 078-8211, Japan

Location

Kobe City General Hospital

Kobe, Hyōgo, 650, Japan

Location

Iwate Medical University Hospital

Morioka, Iwate, 020-8505, Japan

Location

Tsuruoka Municipal Shonai Hospital

Tsuruoka, Yamagata, 997-8515, Japan

Location

Yamagata Prefectural Central Hospital

Yamagata, Yamagata, 990-2292, Japan

Location

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

IrinotecanChemotherapy, AdjuvantNeoadjuvant Therapy

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Intervention Hierarchy (Ancestors)

CamptothecinAlkaloidsHeterocyclic CompoundsCombined Modality TherapyTherapeuticsDrug Therapy

Study Officials

  • Mitsukazu Gotoh, MD

    Fukushima Medical University Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Masking
NONE
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 22, 2005

First Posted

August 24, 2005

Study Start

September 1, 2004

Primary Completion

August 1, 2008

Last Updated

September 17, 2013

Record last verified: 2010-01

Locations

JP(7)