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

September 20, 2012 updated by: European Organisation for Research and Treatment of Cancer - EORTC

Randomized Phase III Study of Preoperative Chemotherapy Followed by Surgery Versus Surgery Alone in Locally Advanced Gastric Cancer (cT3 and cT4NxM0)

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

  • 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

Enrollment (Actual)

144

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 69 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

Age:

  • 18 to 69

Performance status:

  • WHO 0-1

Life expectancy:

  • Not specified

Hematopoietic:

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

Hepatic:

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

Renal:

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

Cardiovascular:

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

Other:

  • 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

PRIOR CONCURRENT THERAPY:

Biologic therapy:

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

Chemotherapy:

  • No prior chemotherapy

Endocrine therapy:

  • Not specified

Radiotherapy:

  • No prior radiotherapy

Surgery:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Masking: None (Open Label)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

European Organisation for Research and Treatment of Cancer - EORTC

Investigators

  • Study Chair: Christoph Schuhmacher, Technical University of Munich

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 1999

Primary Completion (Actual)

February 1, 2004

Study Registration Dates

First Submitted

December 10, 1999

First Submitted That Met QC Criteria

January 26, 2003

First Posted (Estimate)

January 27, 2003

Study Record Updates

Last Update Posted (Estimate)

September 24, 2012

Last Update Submitted That Met QC Criteria

September 20, 2012

Last Verified

September 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EORTC-40954

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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