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A Study of the Combination of Oxaliplatin, Capecitabine, and Trastuzumab With Chemoradiotherapy in the Adjuvant Setting in Operated Participants With Human Epidermal Growth Factor Receptor-2 Positive (HER2+) Gastric or Gastroesophageal Junction Cancer (TOXAG)

7. oktober 2019 opdateret af: Hoffmann-La Roche

Safety and Tolerability of Oxaliplatin-Capecitabine-Trastuzumab Combination and Chemoradiotherapy in Operated Patients With HER-2 Positive Gastric or Gastroesophageal Junction Adenocarcinoma: Phase II Study, TOXAG [ML25574]

This single-arm, open-label study will evaluate the safety and efficacy of the combination oxaliplatin, capecitabine, and trastuzumab with chemoradiotherapy in the adjuvant setting in participants with curatively resected HER2+ gastric or gastroesophageal junction cancer. Participants will receive trastuzumab 8 milligrams per kilogram (mg/kg) intravenously (IV) on Day 1 of Cycle 1 and 6 mg/kg IV on Day 1 of every following 3-week cycle, with oxaliplatin 100 milligrams per square meter (mg/m^2) IV on Day 1 of Cycles 1-3, and capecitabine 850 mg/m^2 orally twice daily on Days 1-14 of Cycles 1-3 and on 5 days per week during chemoradiotherapy. Radiotherapy will be given at a total dose of 45 gray (Gy) divided into 25 doses on 5 treatment days each week for 5 weeks starting Day 22 of Cycle 3. Anticipated time on study treatment is 1 year plus a 1-year follow-up period.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

34

Fase

  • Fase 2

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Kalkun
      • Adana, Kalkun, 01250
        • Baskent University Adana Dr. Turgut Noyan Practice and Research Hospital; Medical Oncology
      • Ankara, Kalkun, 06200
        • Ankara Oncology Hospital; Oncology
      • Ankara, Kalkun, 06100
        • Hacettepe Uni Medical Faculty Hospital; Oncology Dept
      • Ankara, Kalkun, 06490
        • Baskent University Medical Faculty; Internal Medicine
      • Gaziantep, Kalkun, 27310
        • Gaziantep University Medical Faculty, Medical Oncology Department
      • Istanbul, Kalkun, 34890
        • Marmara Uni Faculty of Medicine; Medical Oncology
      • Izmir, Kalkun, 35100
        • Ege Uni Medical Faculty; Oncology Dept
      • Konya, Kalkun, 42080
        • Necmettin Erbakan University Meram Medical Faculty ; Internal Diseases
      • Çankaya/Ankara, Kalkun, 06800
        • Bilkent Sehir Hospita; ONKOLOJI

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 75 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Curatively resected HER2+ gastric or gastroesophageal junction adenocarcinoma; HER2+ status as defined by immunohistochemistry-2 positive or 3 positive with corroborative Fluorescence In Situ Hybridization+ result
  • Participants with stages between Stage IB (T1N1M0) and Stage IIIC
  • ECOG performance status score equal to or less than (<=) 2 during screening
  • Left ventricular ejection fraction equal to or higher than (>=) 55% with acceptable levels of liver and renal functions
  • No known contraindication to capecitabine, oxaliplatin, and trastuzumab
  • No contraindication for radiotherapy or has not received any previous radiotherapy to the gastric region for any reason

Exclusion Criteria:

  • Participants with a malign condition in the last 5 years except squamous cell carcinoma of the skin
  • Previous neoadjuvant chemotherapy and/or radiotherapy
  • Any disruption in the physical integrity of the upper gastrointestinal tract (except surgical intervention for gastric or gastroesophageal junction carcinoma)
  • Known (previously diagnosed and ongoing) malabsorption syndrome
  • Active gastrointestinal bleeding
  • Participants with Stage IV gastric or gastroesophageal junction adenocarcinoma
  • Clinically significant cardiac or cardiovascular disease
  • Uncontrolled hypertension
  • Participants who have received any investigational anti-cancer treatment or are being treated in a concomitant investigational drug study
  • Abnormal laboratory values at screening for serum total bilirubin, alanine aminotransferase or aspartate amino transferase, alkaline phosphatase, absolute neutrophil count, platelet count, and/or hemoglobin
  • Known or suspected hypersensitivity against trastuzumab or proteins of rodents
  • Pregnancy or lactation

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Combination Therapy
Participants will receive combination therapy comprising of trastuzumab, oxaliplatin, capecitabine, and radiation.
Medicin: Oxaliplatin
Participants will receive oxaliplatin 100 mg/m^2 IV on Day 1 of Cycles 1-3.
Stråling: Radiation
Participants will receive radiotherapy at total dose of 45 Gy divided into 25 doses, 5 treatments per week for 5 weeks starting on Day 1 of Cycle 4.
Medicin: Capecitabine
Participants will receive capecitabine 850 mg/m^2 orally twice daily on Days 1-14 of Cycles 1-3 and on 5 days per week during chemoradiotherapy.
Medicin: Trastuzumab
Participants will receive trastuzumab 8 mg/kg IV on Day 1 Cycle 1, 6 mg/kg IV on Day 1 of each following 3-week cycle for 12 months (a total of 17 doses).

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Tidsramme: Baseline up to Month 13
Baseline up to Month 13
Change from Baseline in Eastern Cooperative Oncology Group (ECOG) Performance Status Score
Tidsramme: From Baseline to Month 13
From Baseline to Month 13

Sekundære resultatmål

Resultatmål
Tidsramme
Percentage of Participants with Disease-Free Survival, Using Response Evaluation Criteria for Solid Tumors (RECIST)
Tidsramme: Cycle 1 Day 1 up to tumor relapse or death due to any reason, whichever occurs first (up to 24 months)
Cycle 1 Day 1 up to tumor relapse or death due to any reason, whichever occurs first (up to 24 months)
Overall Survival
Tidsramme: Cycle 1 Day 1 up to death due to any reason (up to 24 months)
Cycle 1 Day 1 up to death due to any reason (up to 24 months)

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Hoffmann-La Roche

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

29. januar 2013

Primær færdiggørelse (Faktiske)

21. august 2015

Studieafslutning (Faktiske)

15. juni 2017

Datoer for studieregistrering

Først indsendt

10. december 2012

Først indsendt, der opfyldte QC-kriterier

12. december 2012

Først opslået (Skøn)

13. december 2012

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

9. oktober 2019

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

7. oktober 2019

Sidst verificeret

1. oktober 2019

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • ML25574

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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