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

This study has been terminated.
(low accrual)
Sponsor:
Information provided by (Responsible Party):
European Organisation for Research and Treatment of Cancer - EORTC
ClinicalTrials.gov Identifier:
NCT00004099
First received: December 10, 1999
Last updated: September 20, 2012
Last verified: September 2012
  Purpose

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 Intervention Phase
Gastric Cancer
Drug: cisplatin
Drug: fluorouracil
Drug: leucovorin calcium
Procedure: neoadjuvant therapy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Masking: 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)

Resource links provided by NLM:


Further study details as provided by European Organisation for Research and Treatment of Cancer - EORTC:

Enrollment: 144
Study Start Date: July 1999
Primary Completion Date: February 2004 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years to 69 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00004099

Locations
Belgium
Institut Jules Bordet
Brussels, Belgium, 1000
Egypt
National Cancer Institute of Egypt
Cairo, Egypt
Germany
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
Netherlands
Academisch Ziekenhuis Maastricht
Maastricht, Netherlands, 6202 AZ
Portugal
Instituto Portugues de Oncologia Centro do Porto, SA
Porto, Portugal, 4200
Sponsors and Collaborators
European Organisation for Research and Treatment of Cancer - EORTC
Investigators
Study Chair: Christoph Schuhmacher Technische Universität München
  More Information

Publications:
Responsible Party: European Organisation for Research and Treatment of Cancer - EORTC
ClinicalTrials.gov Identifier: NCT00004099     History of Changes
Other Study ID Numbers: EORTC-40954, EORTC-40954
Study First Received: December 10, 1999
Last Updated: September 20, 2012
Health Authority: United States: Federal Government

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
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Fluorouracil
Levoleucovorin
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antimetabolites, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antidotes
Protective Agents

ClinicalTrials.gov processed this record on September 22, 2014