NCT00002722

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug and giving higher doses may kill more tumor cells. PURPOSE: Randomized phase II trial to study the effectiveness of high-dose chemotherapy in treating patients with advanced stomach cancer.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
135

participants targeted

Target at P75+ for phase_2 gastric-cancer

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 1996

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 1999

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed
4.5 years until next milestone

First Posted

Study publicly available on registry

April 22, 2004

Completed
Last Updated

March 5, 2012

Status Verified

March 1, 2012

Enrollment Period

3.6 years

First QC Date

November 1, 1999

Last Update Submit

March 2, 2012

Conditions

Gastric Cancer

Keywords

stage III gastric cancerstage IV gastric cancer

Interventions

cisplatinDRUG
fluorouracilDRUG
leucovorin calciumDRUG

Eligibility Criteria

AgeUp to 75 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: Histologically confirmed gastric cancer that is either metastatic or locally advanced and inoperable Bidimensionally measurable disease No CNS metastasis PATIENT CHARACTERISTICS: Age: 75 and under Performance status: WHO 0-2 Life expectancy: At least 3 months Hematopoietic: Granulocyte count at least 2,000/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.7 mg/dL Renal: Creatinine no greater than 1.3 mg/dL Creatinine clearance greater than 60 mL/min Cardiovascular: No myocardial infarction within past 12 months No coronary heart disease requiring drug therapy Congestive heart failure or arrhythmia treatable with standard medication allowed Other: No active infection No history of severe mental disorder No other malignancy within past 10 years except carcinoma in situ of the cervix or nonmelanoma skin cancer Not pregnant PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy Surgery: Not specified

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

Sponsors & Collaborators

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

CisplatinFluorouracilLeucovorin

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Intervention Hierarchy (Ancestors)

Chlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum CompoundsUracilPyrimidinonesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsFormyltetrahydrofolatesTetrahydrofolatesFolic AcidPterinsPteridinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingCoenzymesEnzymes and Coenzymes

Study Officials

  • Hansjochen Wilke, MD

    Kliniken Essen-Mitte

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Purpose
TREATMENT
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 1, 1999

First Posted

April 22, 2004

Study Start

January 1, 1996

Primary Completion

August 1, 1999

Last Updated

March 5, 2012

Record last verified: 2012-03