- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01497041
A Phase II Clinical Trial of Docetaxel, Oxaliplatin Combination Chemotherapy in Patients With Stage IIIB/IV Non-adenocarcinoma, Non-small Cell Lung Cancer (NSCLC) as Second-line Treatment
Goals
The primary goal of this phase II trial is to:
evaluate the response rate of combination chemotherapy with docetaxel and oxaliplatin in patients with stage IIIB/IV non-adenocarcinoma, non-small cell lung cancer (NSCLC) as second-line treatment
Secondary goals are to:
evaluate the treatment-related toxicities of this combination, investigate progression-free survival (PFS) and overall survival (OS) in this population
- Design The proposed clinical trial is an open label, non-comparative, multicenter phase II trial according to the two stage testing design by Simon two-stage testing procedure
Studieoversigt
Status
Intervention / Behandling
Undersøgelsestype
Tilmelding (Forventet)
Fase
- Fase 2
Kontakter og lokationer
Studiekontakt
- Navn: Hwan Jung Yun
- Telefonnummer: +82-42-280-7157
- E-mail: hjyun@cnu.ac.kr
Undersøgelse Kontakt Backup
- Navn: Sang Byung Bae
- Telefonnummer: +82-41-570-3667
- E-mail: baesan@schmc.ac.kr
Studiesteder
-
-
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Cheonan, Korea, Republikken
- Rekruttering
- Soonchunhyang University Cheonan Hospital
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Kontakt:
- Sang Byung Bae, M.D.
- Telefonnummer: +82-41-570-3667
- E-mail: baesan@schmc.ac.kr
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Ledende efterforsker:
- Sang Byung Bae, M.D.
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Underforsker:
- Han Jo Kim, M.D.
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Underforsker:
- Kyu Taek Lee, M.D.
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Cheongju, Korea, Republikken
- Rekruttering
- Chungbuk National University Hospital
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Ledende efterforsker:
- Ki Hyeong Lee
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Kontakt:
- Ki Hyeong Lee
- Telefonnummer: +82-43-269-6015
- E-mail: kihlee@chungbuk.ac.kr
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Underforsker:
- Hye Suk Han
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Daejeon, Korea, Republikken
- Rekruttering
- Chungnam National University Hospital
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Kontakt:
- Hwan Jung Yun
- Telefonnummer: +82-42-280-7157
- E-mail: hjyun@cnuh.co.kr
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Underforsker:
- Sam Yong Kim
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Underforsker:
- Hyo Jin Lee
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Daejeon, Korea, Republikken
- Rekruttering
- The Catholic University of Korea Daejeon ST. Mary's hospital
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Kontakt:
- Suk Young Park
- Telefonnummer: +82-42-220-9832
- E-mail: sypark1011@hotmail.com
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Ledende efterforsker:
- Suk Young Park
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Underforsker:
- Young Joon Yang
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Underforsker:
- Ji Chan Park
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Jeonju, Korea, Republikken
- Rekruttering
- Chonbuk National University Hospital
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Kontakt:
- Eun-Kee Song
- Telefonnummer: +82-63-254-1609
- E-mail: eksong@jbnu.ac.kr
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Ledende efterforsker:
- Eun-kee Song
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Underforsker:
- Chang-Yeol Yim
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Underforsker:
- Na-Ri Lee
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Patients who were diagnosed as non-adenocarcinoma, non-small cell carcinoma of lung histologically or cytologically
- Patients must be ≥ 18 years old of age
- ECOG performance status ≤ 1
- Estimated life expectancy of more than 3 months
- Treatment with only one prior chemotherapy
- At least one lesion that can be measured by imaging (CT/MRI) according to the Response Evaluation Criteria in Solid Tumors (RECIST v1.1)
- Adequate bone marrow function (absolute neutrophil count [ANC] ≥ 1,500/µL, hemoglobin ≥ 9.0 g/dL [correction by transfusion is acceptable], and platelets ≥ 100,000/µL)
- Adequate kidney function (serum creatinine < 1.5 x upper limit of normal [ULN])
- Adequate liver function (serum total bilirubin < 1.5xULN; serum transaminases levels < 2.5xUNL)
- Provision of fully informed consent prior to any study specific procedures
Exclusion Criteria:
- Pregnant or breastfeeding women and women of childbearing potential not employing adequate contraception
- Patients who received prior chemotherapy including paclitaxel or docetaxel
- Patients with second primary cancer (except, adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumors curatively treated with no evidence of disease for ≥5 years)
- Patients with defect of central nervous system (CNS) or any psychiatric disorders and CNS metastases
- Other serious illness or medical conditions A. Clinically significant cardiac disease (uncontrolled congestive heart disease despite treatment [NYHA class III or IV], symptomatic coronary artery disease, unstable angina or myocardial infarction, conduction abnormality like grade 2 AV block, serious arrhythmia needed for medication, uncontrolled hypertension) within 6 months prior to study entry B. Liver cirrhosis (≥ Child-Pugh class B) C. History of significant neurologic or psychiatric disorders including dementia or seizures D. Active uncontrolled infection E. Other serious underlying medical conditions which could impair the ability of the patient to participate in the study
- Concomitant administration of any other experimental drug under investigation, or concomitant chemotherapy, hormonal therapy, or immunotherapy
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Response rate
Tidsramme: 2years
|
Assessment of response will be assessed according to RECIST v1.1 criteria
|
2years
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Overall survival
Tidsramme: 2years
|
Overall survival will be calculated by Kaplan-Meier method
|
2years
|
Progression free survival
Tidsramme: 2 years
|
Progression free survival will be calculated by Kaplan-Meier method
|
2 years
|
Number of Participants with Adverse Events
Tidsramme: 2 years
|
Assessment of toxicity will be assessed according to CTCAE version 4.0
|
2 years
|
Quality of life
Tidsramme: 2 years
|
Quality of life will be assessed according to EORTC QLQ-C30, LC13
|
2 years
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Sang Byung Bae, M.D., Soonchunhyang University Hospital
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Forventet)
Studieafslutning (Forventet)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Luftvejssygdomme
- Neoplasmer efter histologisk type
- Neoplasmer
- Lungesygdomme
- Neoplasmer efter sted
- Neoplasmer, kirtel og epitel
- Neoplasmer i luftvejene
- Thoracale neoplasmer
- Karcinom, bronkogent
- Bronkiale neoplasmer
- Lungeneoplasmer
- Neoplasmer, pladecelle
- Karcinom, ikke-småcellet lunge
- Karcinom
- Karcinom, pladecelle
- Karcinom, storcellet
- Molekylære mekanismer for farmakologisk virkning
- Antineoplastiske midler
- Tubulin modulatorer
- Antimitotiske midler
- Mitose modulatorer
- Docetaxel
- Oxaliplatin
Andre undersøgelses-id-numre
- KSWOG 2010-3
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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