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Post-marketing Surveillance Study of Docetaxel-Based Chemotherapy

21. november 2016 opdateret af: Yung Shin Pharm. Ind. Co., Ltd.

A Post-marketing Surveillance Study to Evaluate the Effectiveness and Safety of Docetaxel-Based Chemotherapy

A Post-marketing Surveillance Study to Evaluate the Effectiveness and Safety of Docetaxel-Based Chemotherapy

Studieoversigt

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

40

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

20 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Sandsynlighedsprøve

Studiebefolkning

A total of 40 evaluable patients with locally advanced or metastatic NSCLC, SCCHN or esophageal cancer will be equally randomized to either Nolbaxol or Taxotere.

Beskrivelse

Inclusion Criteria:

-Histologically or cytologically confirmed unresectable locally advanced NSCLC with progressed or recurred after no more than four previous docetaxel-free chemotherapy regimens, or unresectable locally advanced or metastatic SCCHN or recurred after previous docetaxel-free chemotherapy regimens

Exclusion Criteria:

  1. Women who are nursing or pregnant during the study period;
  2. Patients with carcinoid tumors, small-cell carcinoma of the lung;
  3. A history of another malignancy within the last five years (except for cured basal cell carcinoma of the skin and cured carcinoma in situ of the uterine cervix);
  4. Any other morbidity or situation with contraindications for chemotherapy (e.g. active infection, myocardial infarction in the preceding 6 months);
  5. Neutrophil counts < 1,500 cells/mm3;
  6. A history of hypersensitivity to docetaxel or cisplatin;
  7. Symptomatic heart disease including unstable angina, congestive heart failure or uncontrolled arrhythmias;
  8. Subjects have active hepatitis;
  9. Subjects are known positive for Human Immunodeficiency Virus (HIV);
  10. Any condition judged by investigator, participates the study will jeopardize patient's wellbeing

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
Nolbaxol
For Nonsmall Cell Lung Cancer (NSCLC) Docetaxel (either Group I or Group II) 60 mg/m2 will be administrated by intravenous infusion for 1 hour every 3 weeks (a study medication cycle) and up to 4 study medication cycles throughout this study. For Squamous Cell Carcinoma of the Head and Neck (SCCHN) Docetaxel (either Group I or Group II) 60 mg/m2 will be administrated by intravenous infusion for 1 hour followed by cisplatin 60 ~ 75 mg/m2 for 1-3 hours or based on the general practice of the site every 3 weeks and up to 4 study medication cycles throughout this study.
Andre navne:
  • docetaxel
Taxotere
For Nonsmall Cell Lung Cancer (NSCLC) Docetaxel (either Group I or Group II) 60 mg/m2 will be administrated by intravenous infusion for 1 hour every 3 weeks (a study medication cycle) and up to 4 study medication cycles throughout this study. For Squamous Cell Carcinoma of the Head and Neck (SCCHN) Docetaxel (either Group I or Group II) 60 mg/m2 will be administrated by intravenous infusion for 1 hour followed by cisplatin 60 ~ 75 mg/m2 for 1-3 hours or based on the general practice of the site every 3 weeks and up to 4 study medication cycles throughout this study.
Andre navne:
  • docetaxel

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Progression-Free Survival (PFS)
Tidsramme: Every 8 weeks after post-dosing follow-up visit, and conducted until disease progression or up to 11 months.
Every 8 weeks after post-dosing follow-up visit, and conducted until disease progression or up to 11 months.

Sekundære resultatmål

Resultatmål
Tidsramme
Overall Response Rate (ORR)
Tidsramme: Every 8 weeks after post-dosing follow-up visit, and conducted until disease progression or up to 11 months.
Every 8 weeks after post-dosing follow-up visit, and conducted until disease progression or up to 11 months.
Adverse Events as a measure on safety
Tidsramme: Adverse event will be evaluated during the study regimens treatment period and up to 8 weeks after the last dose of study regimen visit.
Adverse event will be evaluated during the study regimens treatment period and up to 8 weeks after the last dose of study regimen visit.

Samarbejdspartnere og efterforskere

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

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

1. november 2014

Primær færdiggørelse (Faktiske)

1. oktober 2016

Datoer for studieregistrering

Først indsendt

16. november 2016

Først indsendt, der opfyldte QC-kriterier

21. november 2016

Først opslået (Skøn)

23. november 2016

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

23. november 2016

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

21. november 2016

Sidst verificeret

1. november 2016

Mere information

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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