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Combination Chemotherapy and Surgery in Treating Patients With Locally Advanced Stomach Cancer

14. mai 2012 oppdatert av: Swiss Group for Clinical Cancer Research

A Phase III Trial of Preoperative vs. Postoperative Chemotherapy With Taxotere-Cisplatin-5FU (TCF) in Patients With Locally Advanced Operable Gastric Carcinoma

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one chemotherapy drug with surgery may kill more tumor cells. It is not yet known if chemotherapy followed by surgery is more effective than surgery followed by chemotherapy for stomach cancer.

PURPOSE: This randomized phase III trial is studying surgery followed by combination chemotherapy to see how well it works compared to combination chemotherapy followed by surgery in treating patients with locally advanced stomach cancer.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

OBJECTIVES:

  • Compare, by intention to treat analysis, feasibility and efficacy of 4 courses of docetaxel, cisplatin, and fluorouracil as preoperative or postoperative chemotherapy in patients with locally advanced operable gastric carcinoma.
  • Evaluate the predictive values of some biological and molecular tumor parameters on response to chemotherapy, metastasis and survival in this patient population.

OUTLINE: This is a randomized, open label, multicenter study. Patients are stratified according to study center, tumor site (affecting the Z-line (cardia carcinoma Siewart II and III) vs rest of the stomach), and nodal status (positive vs negative). Patients are randomized to either preoperative chemotherapy followed by surgery (arm I) or surgery followed by postoperative chemotherapy (arm II).

  • Arm I: Patients receive docetaxel IV over 1 hour followed by cisplatin IV over 4 hours on day 1, and fluorouracil IV continuously on days 1-14 every 3 weeks. Patients are evaluated after 2 courses and patients with progressive disease proceed to immediate surgery. Otherwise, treatment continues for a total of 4 courses in the absence of unacceptable toxicity or disease progression. Between 3-5 weeks following day 1 of the last course of chemotherapy, patients undergo gastric resection.
  • Arm II: Patients undergo immediate gastric resection. Beginning 3-6 weeks after surgery, patients receive 4 courses of docetaxel, cisplatin, and fluorouracil as in arm I.

Quality of life is assessed before the first and third courses of chemotherapy, before and after surgery, and then at 1, 3, and 6 months.

Patients are followed every 3 months for 3 years, every 6 months for 2 years, and then annually thereafter.

PROJECTED ACCRUAL: Approximately 240 patients (120 per arm) will be accrued for this study.

Studietype

Intervensjonell

Registrering (Faktiske)

240

Fase

  • Fase 3

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Italia
      • Milan, Italia, 20141
        • European Institute of Oncology
  • Sveits
      • Geneva, Sveits, CH-1211
        • Hôpital Cantonal Universitaire de Genève
      • St. Gallen, Sveits, CH-9006
        • Zentrum fuer Tumordiagnostikund Praevention

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år til 75 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

DISEASE CHARACTERISTICS:

  • Histologically confirmed locally advanced gastric carcinoma that is considered operable

    • T3-4, Nx, M0 OR
    • Tx, N+, M0

  • Lymph nodes considered positive by sonography should be at least 2 of the following:

    • Round
    • Echopoor
    • Sharp borders
    • At least 0.5 cm

  • No distant metastases, including peritoneal carcinomatosis

    • CT scan and peritoneal lavage mandatory

PATIENT CHARACTERISTICS:

Age:

  • 18 to 75

Performance status:

  • 0-2

Life expectancy:

  • Greater than 12 weeks

Hematopoietic:

  • WBC at least 4,000/mm^3
  • Platelet count at least 100,000/mm^3

Hepatic:

  • Bilirubin normal
  • AST or ALT no greater than 1.5 times upper limit of normal (ULN)
  • Alkaline phosphatase no greater than 2.5 times ULN

Renal:

  • Adequate renal function within limits to allow for treatment with cisplatin

Cardiovascular:

  • No unstable cardiac disease requiring treatment
  • No congestive heart failure or angina pectoris even if medically controlled
  • No significant arrhythmias
  • No myocardial infarction within past 6 months
  • Ejection fraction greater than 50% on cardiac sonography or MUGA scan

Other:

  • Not pregnant or nursing
  • Fertile patients must use effective contraception
  • No other prior malignancy except basal cell carcinoma of the skin or adequately treated carcinoma in situ of the cervix
  • No grade 2 or greater peripheral neuropathy of any origin (e.g., alcohol, diabetic)
  • No history of anaphylaxis
  • No other serious concurrent illness or medical condition that would preclude study therapy
  • No history of significant neurologic or psychiatric disorders (e.g., psychotic disorders, dementia, or seizures)

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • No concurrent biologic therapy for gastric carcinoma

Chemotherapy:

  • No other concurrent chemotherapy for gastric carcinoma

Endocrine therapy:

  • No concurrent endocrine therapy for gastric carcinoma

Radiotherapy:

  • No concurrent radiotherapy for gastric carcinoma

Surgery:

  • See Disease Characteristics

Other:

  • At least 30 days since prior treatment in a clinical trial
  • No other concurrent experimental drugs
  • No other concurrent anticancer therapy

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Faktoriell oppgave
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Aktiv komparator: Taxotere-Cisplatin-5FU preoperatively
TCF preoperatively
Legemiddel: Taxotere-Cisplatin-5FU
Preoperatively
Aktiv komparator: Immediate surgery followed by TCF
Surgery followed by Taxotere-Cisplatin-5FU
Legemiddel: Immediate surgery
Immediate surgery followed by Taxotere-Cisplatin-5FU

Hva måler studien?

Primære resultatmål

Resultatmål
Begivenhetsfri overlevelse

Sekundære resultatmål

Resultatmål
Total overlevelse
Tid til behandlingssvikt målt etter avsluttet studiebehandling
Toxicity measured after completion of study treatment
Rate of complete resection (RO) and postoperative mortality as measured after surgery

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Swiss Group for Clinical Cancer Research

Etterforskere

  • Studiestol: Rudolf Morant, MD, Tumor Zentrum ZeTup St. Gallen und Chur

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. november 1999

Primær fullføring (Faktiske)

1. november 2005

Studiet fullført (Faktiske)

1. mars 2006

Datoer for studieregistrering

Først innsendt

6. april 2000

Først innsendt som oppfylte QC-kriteriene

26. januar 2003

Først lagt ut (Anslag)

27. januar 2003

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

15. mai 2012

Siste oppdatering sendt inn som oppfylte QC-kriteriene

14. mai 2012

Sist bekreftet

1. mai 2012

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • SAKK 43/99
  • SWS-SAKK-43/99 (Annen identifikator: SAKK)
  • EU-99042

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Kliniske studier på Magekreft

Kliniske studier på Taxotere-Cisplatin-5FU

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Sponsorer og samarbeidspartnere

Medisinsk tilstand

Legemiddelintervensjoner

CROs by country

CROs in Cameroon

Forhold

Sjeldne sykdommer

Legemiddelintervensjoner

Kosttilskudd

Sponsor / samarbeidspartnere

Steder

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