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

NCT00004099 | Terminated Phase 3

• 1 other identifier: EORTC-40954
• Study Type: interventional
• Target: 144
• Locations: 5 countries
• Sites: 18

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.

Conditions

Gastric Cancer

Keywords

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

Interventions

cisplatin DRUG

fluorouracil DRUG

leucovorin calcium DRUG

neoadjuvant therapy PROCEDURE

Eligibility Criteria

• Age: 18 Years - 69 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

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

Sponsors & Collaborators

• European Organisation for Research and Treatment of Cancer - EORTC: lead

Study Sites (18)

Institut Jules Bordet

Brussels, 1000, Belgium

Location

National Cancer Institute of Egypt

Cairo, Egypt

Location

Robert Roessle Klinik

Berlin, D-13122, Germany

Location

Klinik & Poliklinik fur Strahlentherapie der Universitat zu Koln

Cologne, D-50924, Germany

Location

Medizinische Klinik I

Dresden, D-01307, Germany

Location

Universitaetsklinik Duesseldorf

Düsseldorf, D-40225, Germany

Location

Department of Medicine III

Erlangen, D-91054, Germany

Location

Kliniken Essen - Mitte

Essen, D-45136, Germany

Location

Evangelisches Bethesda Krankenhaus GmbH

Essen, D-45355, Germany

Location

Krankenhaus Nordwest

Frankfurt, D-60488, Germany

Location

Klinikum der J.W. Goethe Universitaet

Frankfurt, D-60590, Germany

Location

Universitatsklinik - Saarland

Homburg, D-66421, Germany

Location

Kreiskrankenhaus Meissen

Meissen, D-01657, Germany

Location

Klinikum Rechts Der Isar/Technische Universitaet Muenchen

Munich, D-81675, Germany

Location

Westfaelische Wilhelms-Universitaet

Münster, DOH-48149, Germany

Location

Staedtisches Krankenhaus

Solingen, D-42653, Germany

Location

Academisch Ziekenhuis Maastricht

Maastricht, 6202 AZ, Netherlands

Location

Instituto Portugues de Oncologia Centro do Porto, SA

Porto, 4200, Portugal

Location

Related Publications (2)

• Schuhmacher C, Gretschel S, Lordick F, Reichardt P, Hohenberger W, Eisenberger CF, Haag C, Mauer ME, Hasan B, Welch J, Ott K, Hoelscher A, Schneider PM, Bechstein W, Wilke H, Lutz MP, Nordlinger B, Van Cutsem E, Siewert JR, Schlag PM. Neoadjuvant chemotherapy compared with surgery alone for locally advanced cancer of the stomach and cardia: European Organisation for Research and Treatment of Cancer randomized trial 40954. J Clin Oncol. 2010 Dec 10;28(35):5210-8. doi: 10.1200/JCO.2009.26.6114. Epub 2010 Nov 8.

  PMID: 21060024 RESULT

• Schuhmacher C, Schlag P, Lordick F, et al.: Neoadjuvant chemotherapy versus surgery alone for locally advanced adenocarcinoma of the stomach and cardia: randomized EORTC phase III trial #40954. [Abstract] J Clin Oncol 27 (Suppl 15): A-4510, 2009.

  RESULT

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Cisplatin; Fluorouracil; Leucovorin; Neoadjuvant Therapy

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Coenzymes; Enzymes and Coenzymes; Combined Modality Therapy; Therapeutics

Study Officials

• Christoph Schuhmacher

  Technical University of Munich

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 1999
• First Posted: January 27, 2003
• Study Start: July 1, 1999
• Primary Completion: February 1, 2004
• Last Updated: September 24, 2012

Record last verified: 2012-09

Locations

NL (1); EG (1); PT (1); DE (14); BE (1)