NCT00005060

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 chemotherapy drug with surgery may kill more tumor cells. It is not yet known if chemotherapy followed by surgery is more effective than surgery followed by chemotherapy for stomach cancer. PURPOSE: This randomized phase III trial is studying surgery followed by combination chemotherapy to see how well it works compared to combination chemotherapy followed by surgery in treating patients with locally advanced stomach cancer.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
240

participants targeted

Target at P25-P50 for phase_3 gastric-cancer

Timeline
Completed

Started Nov 1999

Typical duration for phase_3 gastric-cancer

Geographic Reach
2 countries

3 active sites

Status
completed

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

November 1, 1999

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

April 6, 2000

Completed
2.8 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2005

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2006

Completed
Last Updated

May 15, 2012

Status Verified

May 1, 2012

Enrollment Period

6 years

First QC Date

April 6, 2000

Last Update Submit

May 14, 2012

Conditions

Gastric Cancer

Keywords

stage II gastric cancerstage III gastric cancer

Outcome Measures

Primary Outcomes (1)

  • Event-free survival

Secondary Outcomes (4)

  • Overall survival

  • Time to treatment failure measured after completion of study treatment

  • Toxicity measured after completion of study treatment

  • Rate of complete resection (RO) and postoperative mortality as measured after surgery

Study Arms (2)

Taxotere-Cisplatin-5FU preoperatively

ACTIVE COMPARATOR

TCF preoperatively

Drug: Taxotere-Cisplatin-5FU

Immediate surgery followed by TCF

ACTIVE COMPARATOR

Surgery followed by Taxotere-Cisplatin-5FU

Drug: Immediate surgery

Interventions

Taxotere-Cisplatin-5FUDRUG

Preoperatively

Taxotere-Cisplatin-5FU preoperatively
Immediate surgeryDRUG

Immediate surgery followed by Taxotere-Cisplatin-5FU

Immediate surgery followed by TCF

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically confirmed locally advanced gastric carcinoma that is considered operable * T3-4, Nx, M0 OR * Tx, N+, M0 * Lymph nodes considered positive by sonography should be at least 2 of the following: * Round * Echopoor * Sharp borders * At least 0.5 cm * No distant metastases, including peritoneal carcinomatosis * CT scan and peritoneal lavage mandatory PATIENT CHARACTERISTICS: Age: * 18 to 75 Performance status: * 0-2 Life expectancy: * Greater than 12 weeks Hematopoietic: * WBC at least 4,000/mm\^3 * Platelet count at least 100,000/mm\^3 Hepatic: * Bilirubin normal * AST or ALT no greater than 1.5 times upper limit of normal (ULN) * Alkaline phosphatase no greater than 2.5 times ULN Renal: * Adequate renal function within limits to allow for treatment with cisplatin Cardiovascular: * No unstable cardiac disease requiring treatment * No congestive heart failure or angina pectoris even if medically controlled * No significant arrhythmias * No myocardial infarction within past 6 months * Ejection fraction greater than 50% on cardiac sonography or MUGA scan Other: * Not pregnant or nursing * Fertile patients must use effective contraception * No other prior malignancy except basal cell carcinoma of the skin or adequately treated carcinoma in situ of the cervix * No grade 2 or greater peripheral neuropathy of any origin (e.g., alcohol, diabetic) * No history of anaphylaxis * No other serious concurrent illness or medical condition that would preclude study therapy * No history of significant neurologic or psychiatric disorders (e.g., psychotic disorders, dementia, or seizures) PRIOR CONCURRENT THERAPY: Biologic therapy: * No concurrent biologic therapy for gastric carcinoma Chemotherapy: * No other concurrent chemotherapy for gastric carcinoma Endocrine therapy: * No concurrent endocrine therapy for gastric carcinoma Radiotherapy: * No concurrent radiotherapy for gastric carcinoma Surgery: * See Disease Characteristics Other: * At least 30 days since prior treatment in a clinical trial * No other concurrent experimental drugs * No other concurrent anticancer therapy

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

Sponsors & Collaborators

Study Sites (3)

European Institute of Oncology

Milan, 20141, Italy

Location

Hopital Cantonal Universitaire de Geneve

Geneva, CH-1211, Switzerland

Location

Zentrum fuer Tumordiagnostikund Praevention

Sankt Gallen, CH-9006, Switzerland

Location

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Study Officials

  • Rudolf Morant, MD

    Tumor Zentrum ZeTup St. Gallen und Chur

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 6, 2000

First Posted

January 27, 2003

Study Start

November 1, 1999

Primary Completion

November 1, 2005

Study Completion

March 1, 2006

Last Updated

May 15, 2012

Record last verified: 2012-05

Locations

CH(2)IT(1)