- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00192036
Multicenter Phase 2 Trial Evaluating Cisplatin-Gemcitabine With Concomitant Thoracic Radiotherapy for Treatment of Inoperable Stage III Non Small Cell Lung Cancer
22. november 2010 opdateret af: Eli Lilly and Company
Multicenter Phase II Trial Evaluating Cisplatin-Gemcitabine With Concomitant Thoracic Radiotherapy for Treatment of Inoperable Stage III Non Small Cell Lung Cancer
The purpose of the study is to evaluate the response rate of patients with non small lung cancer to gemcitabine in combination with radiotherapy.
The tolerability and safety of this combination will also be evaluated.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
49
Fase
- Fase 2
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Aalst, Belgien, 9300
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Charleroi, Belgien, 6000
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Gilly, Belgien, 6060
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Haine-St.- Paul, Belgien, 7100
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Herentals, Belgien, 2200
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Mechelen, Belgien, 2800
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Ottignies, Belgien, 1340
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Turnhout, Belgien, 2300
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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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 og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Inoperable non small cell lung cancer Stage III
- Adequate hematological parameters
- Adequate Lung function reserve
Exclusion Criteria:
- Previous chemotherapy and thoracic radiation for non small cell lung cancer
- Presence of distant metastases
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: Ikke-randomiseret
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: Gemcitabine + Cisplatin
Gemcitabine: 1250 mg/m2, intravenous (IV), day 1 and day 8 every 21 days x 3 cycles (1-3) then 300 mg/m2 x 2 cycles (4-5). Cisplatin: 80 mg/m2, IV, every 21 days x 5 cycles. Radiation: 63 Gray (Gy) in 35 treatments over 7 weeks concurrent with chemotherapy cycles 4 and 5. |
1250 mg/m2, intravenous (IV), day 1 and day 8 every 21 days x 3 cycles (1-3) then 300 mg/m2 x 2 cycles (4-5)
Andre navne:
80 mg/m2, IV, every 21 days x 5 cycles
63 Gray (Gy) in 35 treatments over 7 weeks concurrent with chemotherapy cycles 4 and 5
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Tumor Response at End of Treatment
Tidsramme: baseline to first follow-up visit (up to 8 weeks after end of chemo-radiation)
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Response recorded at the first follow-up visit using Response Evaluation Criteria In Solid Tumors (RECIST) criteria.
Complete Response=disappearance of all target lesions; Partial Response=30% decrease in sum of longest diameter of target lesions; Progressive Disease=20% increase in sum of longest diameter of target lesions; Stable Disease=small changes that do not meet above criteria.
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baseline to first follow-up visit (up to 8 weeks after end of chemo-radiation)
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Time to Progressive Disease
Tidsramme: Preliminary: baseline to measured progressive disease (up to 3.5 years); Final: baseline to measured progressive disease (up to 5 years);
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Time to progressive disease is the time from the date of enrollment to the first date of documented disease progression.
Patients who have not had disease progression will be censored at the date of the last follow-up visit.
Patients dying because of reasons other than tumor progression are not included.
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Preliminary: baseline to measured progressive disease (up to 3.5 years); Final: baseline to measured progressive disease (up to 5 years);
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Overall Survival
Tidsramme: Preliminary: baseline to date of death from any cause (up to 3.5 years); Final: baseline to date of death from any cause (up to 5 years)
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Overall survival is the duration from enrollment to death.
For patients who are alive, overall survival is censored at the last contact.
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Preliminary: baseline to date of death from any cause (up to 3.5 years); Final: baseline to date of death from any cause (up to 5 years)
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Safety of Induction Chemotherapy
Tidsramme: every cycle (21 days) for 3 cycles (up to 10 weeks)
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A grading (severity) scale is provided for each adverse event term.
Toxicities were graded according to the National Cancer Institute Common Toxicity Criteria (NCI-CTC) Version 2.0 grading scales.
Grades range from 0 (none) to 5 (death).
Number of participants with clinically significant Grade 3 and Grade 4 toxicities occurring during induction chemotherapy are reported.
Grade 3 events are severe and Grade 4 events are life-threatening.
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every cycle (21 days) for 3 cycles (up to 10 weeks)
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Safety of Chemo-radiotherapy
Tidsramme: Cycles 4 and 5 up to 8 weeks after the end of chemo-radiotherapy
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A grading (severity) scale is provided for each adverse event term.
Toxicities were graded according to NCI-CTC Version 2.0 grading scales.
For specific radiation events, Radiation Therapy Oncology Group/European Organization for Research and Treatment of Cancer late radiation toxicity scale was used.
Grades range from 0 (none) to 5 (death).
Number of participants with clinically significant acute Grade 3 and Grade 4 toxicities (worst severity) occurring during chemo-radiation and up to 49 days (8 weeks) after are reported.
Grade 3 events are severe and Grade 4 events are life-threatening.
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Cycles 4 and 5 up to 8 weeks after the end of chemo-radiotherapy
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
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. august 2004
Primær færdiggørelse (Faktiske)
1. januar 2008
Studieafslutning (Faktiske)
1. november 2009
Datoer for studieregistrering
Først indsendt
12. september 2005
Først indsendt, der opfyldte QC-kriterier
12. september 2005
Først opslået (Skøn)
19. september 2005
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
9. december 2010
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
22. november 2010
Sidst verificeret
1. november 2010
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Luftvejssygdomme
- Neoplasmer
- Lungesygdomme
- Neoplasmer efter sted
- Neoplasmer i luftvejene
- Thoracale neoplasmer
- Karcinom, bronkogent
- Bronkiale neoplasmer
- Lungeneoplasmer
- Karcinom, ikke-småcellet lunge
- Lægemidlers fysiologiske virkninger
- Molekylære mekanismer for farmakologisk virkning
- Anti-infektionsmidler
- Antivirale midler
- Enzymhæmmere
- Antimetabolitter, Antineoplastisk
- Antimetabolitter
- Antineoplastiske midler
- Immunsuppressive midler
- Immunologiske faktorer
- Gemcitabin
- Cisplatin
Andre undersøgelses-id-numre
- 8984 (CTEP)
- B9E-BX-JHSQ (Anden identifikator: Eli Lilly and Company)
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 .
Kliniske forsøg med Ikke småcellet lungekræft
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AHS Cancer Control AlbertaCross Cancer InstituteAfsluttetOmfattende Stage Small Cel Lung CancerCanada
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Universitaire Ziekenhuizen KU LeuvenUkendtLymfom | Hodgkin lymfom | Non-Hodgkin lymfom (follikulært, diffust B-cel lymfom, PTLD og Mantle Cel lymfom)Belgien
Kliniske forsøg med gemcitabine
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AstraZenecaRekrutteringGaldevejskræftFrankrig, Spanien, Italien, Korea, Republikken, Japan, Forenede Stater, Tyskland, Singapore
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Sierra Oncology LLC - a GSK companyAfsluttetAvancerede solide tumorerSpanien, Det Forenede Kongerige
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University of Erlangen-Nürnberg Medical SchoolAfsluttetKræft i bugspytkirtlenTyskland
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Kansai Hepatobiliary Oncology GroupAfsluttet
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Shenzhen University General HospitalIkke rekrutterer endnu
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Fifth Affiliated Hospital, Sun Yat-Sen UniversityRekruttering
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University of ZurichAfsluttetKræft i bugspytkirtlenFrankrig, Schweiz, Belgien, Tyskland
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Samsung Medical CenterAfsluttetKræft i bugspytkirtlenKorea, Republikken
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3D Medicines (Sichuan) Co., Ltd.Ikke rekrutterer endnuGaldevejsneoplasmer
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Centro Nacional de Investigaciones Oncologicas...Apices Soluciones S.L.; Hospital Universitario de Fuenlabrada; Grupo Hospital...AfsluttetAvanceret pancreascarcinomSpanien