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AzTrials

Gastric CancerPhase 3NCT00004099

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

A Phase 3 study testing cisplatin, fluorouracil and leucovorin calcium in people with Gastric Cancer, run by European Organisation for Research and Treatment of Cancer - EORTC at 18 sites in 5 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 69 years
Conditions the study is for
Gastric Cancer
What is being tested?
cisplatin, fluorouracil and leucovorin calcium
Type of treatment
Surgery or procedure
How many people
144 participants
Where
18 sitesin 5 countries
Study dates
Jul 1999to Feb 2004
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 69 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Trial locations and contacts

18 sites in 5 countries.

18 sites in 5 countries

Germany14 sites

  • Robert Roessle Klinik

    Berlin, D-13122

  • Klinik & Poliklinik fur Strahlentherapie der Universitat zu Koln

    Cologne, D-50924

  • Medizinische Klinik I

    Dresden, D-01307

  • Universitaetsklinik Duesseldorf

    Düsseldorf, D-40225

  • Department of Medicine III

    Erlangen, D-91054

  • Kliniken Essen - Mitte

    Essen, D-45136

  • Evangelisches Bethesda Krankenhaus GmbH

    Essen, D-45355

  • Krankenhaus Nordwest

    Frankfurt, D-60488

  • Klinikum der J.W. Goethe Universitaet

    Frankfurt, D-60590

  • Universitatsklinik - Saarland

    Homburg, D-66421

  • Kreiskrankenhaus Meissen

    Meissen, D-01657

  • Klinikum Rechts Der Isar/Technische Universitaet Muenchen

    Munich, D-81675

  • Westfaelische Wilhelms-Universitaet

    Münster, DOH-48149

  • Staedtisches Krankenhaus

    Solingen, D-42653

Other trials in Germany

Belgium1 site

  • Institut Jules Bordet

    Brussels, 1000

Other trials in Belgium

Egypt1 site

  • National Cancer Institute of Egypt

    Cairo

Other trials in Egypt

Netherlands1 site

  • Academisch Ziekenhuis Maastricht

    Maastricht, 6202 AZ

Other trials in Netherlands

Portugal1 site

  • Instituto Portugues de Oncologia Centro do Porto, SA

    Porto, 4200

Other trials in Portugal

About this study

Official title: 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.

Read the 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.

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
Medical subject headings
Stomach Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jan 2003 (estimated)
  2. Study startJul 1999
  3. Primary completionFeb 2004

Why it stopped: low accrual

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Masking
None (open label)
Enrolment
144 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00004099
Sponsor's protocol ID
EORTC-40954
Other IDs
EORTC-40954
Status last verified
Sep 2012
First submitted
10 Dec 1999
Last updated
24 Sep 2012
Results posted
No

Publications

  • 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.

    PubMed 21060024

  • 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.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing cisplatin, fluorouracil and leucovorin calcium in people with Gastric Cancer, run by European Organisation for Research and Treatment of Cancer - EORTC at 18 sites in 5 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 24 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 18 sites in Germany, Belgium, Egypt, Netherlands, Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: low accrual). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00004099, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2012.

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