Surgery With or Without Combination Chemotherapy in Treating Patients With Stomach Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00004099
Recruitment Status : Terminated (low accrual)
First Posted : January 27, 2003
Last Update Posted : September 24, 2012
Information provided by (Responsible Party):
European Organisation for Research and Treatment of Cancer - EORTC

Brief Summary:

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known if surgery alone or surgery combined with chemotherapy is more effective in treating stomach cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of surgery with or without combination chemotherapy in treating patients who have stage II, stage III, or stage IV stomach cancer.

Condition or disease Intervention/treatment Phase
Gastric Cancer Drug: cisplatin Drug: fluorouracil Drug: leucovorin calcium Procedure: neoadjuvant therapy Phase 3

Detailed Description:


  • Compare overall survival in patients with locally advanced gastric cancer treated with surgery alone or in combination with neoadjuvant cisplatin, leucovorin calcium and fluorouracil.
  • Compare these two regimens in terms of the rate of complete resection, time to progression, and morbidity in these patients.
  • Evaluate toxicity of and disease response to neoadjuvant chemotherapy in these patients.
  • Evaluate quality of life and performance status in these patients pre- and post-surgery and compare quality of life for both regimens.

OUTLINE: This is a randomized, open label, multicenter study. Patients are stratified according to center, primary tumor category (cT3 or cT4), localization of tumor (upper third including cardia II or III vs middle and lower third), gender, and histological subtype (intestinal vs nonintestinal). Patients are randomized to one of two treatment arms.

  • Arm I: Patients receive cisplatin IV over 1 hour on days 1, 15, and 29. Patients also receive leucovorin calcium IV over 2 hours followed by fluorouracil IV over 24 hours on days 1, 8, 15, 22, 29, and 36. A second course is administered beginning 2 weeks later in the absence of disease progression or unacceptable toxicity.

Patients undergo resection and lymphadenectomy on days 57-63 of the second course of chemotherapy.

  • Arm II: Patients undergo resection and lymphadenectomy within 14 days of randomization.

Quality of life is assessed before randomization, every 3 months for 1 year and at 2 years after randomization.

Patients are followed every 3 months for 1 year, every 6 months for 2 years, then every 3 months thereafter until death.

PROJECTED ACCRUAL: A total of 360 patients (180 per arm) will be accrued for this study over 4 years.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 144 participants
Allocation: Randomized
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Phase III Study of Preoperative Chemotherapy Followed by Surgery Versus Surgery Alone in Locally Advanced Gastric Cancer (cT3 and cT4NxM0)
Study Start Date : July 1999
Actual Primary Completion Date : February 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stomach Cancer
U.S. FDA Resources

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 69 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Histologically proven stage II-IV adenocarcinoma of the stomach including cardia carcinoma types II and III

    • Locally resectable disease
    • No distant metastases except M1 lymph nodes
    • No evidence of peritoneal carcinomatosis

      • Free tumor cells in lavage at laparoscopy allowed
  • No uncontrolled bleeding of the primary tumor
  • No gastric outlet syndrome or complete tumor stenosis that would require total parenteral nutrition



  • 18 to 69

Performance status:

  • WHO 0-1

Life expectancy:

  • Not specified


  • WBC greater than 4,000/mm^3
  • Absolute neutrophil count greater than 2,000/mm^3
  • Platelet count greater than 100,000/mm^3


  • Bilirubin no greater than 1.25 times upper limit of normal (ULN)
  • Prothrombin rate at least 70%


  • Creatinine no greater than 1.25 times ULN
  • Creatinine clearance greater than 60 mL/min


  • No prior atrial or ventricular arrhythmias
  • No prior congestive heart failure
  • No myocardial infarction within the past 6 months


  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No other prior or concurrent neoplasm except curatively treated nonmelanoma skin cancer or carcinoma in situ of the cervix
  • No active infection
  • No allergy to protocol drugs
  • No dementia or significantly altered mental status
  • No other serious medical condition that would prevent compliance


Biologic therapy:

  • No filgrastim (G-CSF) within 48 hours prior to chemotherapy


  • No prior chemotherapy

Endocrine therapy:

  • Not specified


  • No prior radiotherapy


  • See Disease Characteristics
  • No prior stent implantation
  • No prior laser therapy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00004099

Institut Jules Bordet
Brussels, Belgium, 1000
National Cancer Institute of Egypt
Cairo, Egypt
Robert Roessle Klinik
Berlin, Germany, D-13122
Medizinische Klinik I
Dresden, Germany, D-01307
Universitaetsklinik Duesseldorf
Duesseldorf, Germany, D-40225
Department of Medicine III
Erlangen, Germany, D-91054
Kliniken Essen - Mitte
Essen, Germany, D-45136
Evangelisches Bethesda Krankenhaus GmbH
Essen, Germany, D-45355
Krankenhaus Nordwest
Frankfurt, Germany, D-60488
Klinikum der J.W. Goethe Universitaet
Frankfurt, Germany, D-60590
Universitatsklinik - Saarland
Homburg, Germany, D-66421
Klinik & Poliklinik fur Strahlentherapie der Universitat zu Koln
Koln, Germany, D-50924
Kreiskrankenhaus Meissen
Meissen, Germany, D-01657
Westfaelische Wilhelms-Universitaet
Muenster, Germany, DOH-48149
Klinikum Rechts Der Isar/Technische Universitaet Muenchen
Munich, Germany, D-81675
Staedtisches Krankenhaus
Solingen, Germany, D-42653
Academisch Ziekenhuis Maastricht
Maastricht, Netherlands, 6202 AZ
Instituto Portugues de Oncologia Centro do Porto, SA
Porto, Portugal, 4200
Sponsors and Collaborators
European Organisation for Research and Treatment of Cancer - EORTC
Study Chair: Christoph Schuhmacher Technische Universität München

Publications of Results:
Responsible Party: European Organisation for Research and Treatment of Cancer - EORTC Identifier: NCT00004099     History of Changes
Other Study ID Numbers: EORTC-40954
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: September 24, 2012
Last Verified: September 2012

Keywords provided by European Organisation for Research and Treatment of Cancer - EORTC:
stage II gastric cancer
stage III gastric cancer
stage IV gastric cancer
intestinal adenocarcinoma of the stomach
diffuse adenocarcinoma of the stomach
mixed adenocarcinoma of the stomach

Additional relevant MeSH terms:
Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Protective Agents