- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00616499
Gefitinib in Treating Patients With Stage IIIA Non-Small Cell Lung Cancer
A Phase II Trial of Neoadjuvant Gefitinib Therapy Based on Mutation Study in Biopsy- Proven Stage IIIA N2 Non-Squamous Non-Small Cell Lung Cancer
RATIONALE: Gefitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving Gefitinib before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.
PURPOSE: This phase II trial is studying how well gefitinib works in treating patients with stage IIIA non-small cell lung cancer.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
OBJECTIVES:
Primary
- To assess the response rate to gefitinib treatment as preoperative induction therapy in patients with biopsy-proven stage IIIA (pN2) non-squamous non-small cell lung cancer accompanied by epidermal growth factor receptor (EGFR) mutations.
Secondary
- To determine the complete resection rate in patients treated with this drug.
- To determine the overall survival rate in patients treated with this drug.
- To determine the disease-free survival rate in patients treated with this drug.
- To determine the pathologic complete response rate in patients treated with this drug.
- To determine the toxicity of this drug in these patients.
OUTLINE: This is a multicenter study.
Patients receive oral gefitinib once a day on days 1-28. Treatment repeats every 28 days for up to 2 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients with resectable disease may undergo surgery. Patients with unresectable disease may undergo surgery, chemotherapy, and/or radiotherapy.
After completion of study therapy, patients are followed for 2 years.
Undersøgelsestype
Tilmelding (Forventet)
Fase
- Fase 2
Kontakter og lokationer
Studiesteder
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Seoul, Korea, Republikken, 110-744
- Rekruttering
- Seoul National University Hospital
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Kontakt:
- Contact Person
- Telefonnummer: 82-2-2072-1742
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Seoul, Korea, Republikken, 135-710
- Rekruttering
- Samsung Medical Center
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Kontakt:
- Contact Person
- Telefonnummer: 82-2-3410-1247
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Seoul, Korea, Republikken, 120-752
- Rekruttering
- Yonsei Cancer Center at Yonsei University Medical Center
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Kontakt:
- Joo-Hang Kim, MD
- Telefonnummer: 82-2-2228-8131
- E-mail: kjhang@yuhs.ac
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Seoul, Korea, Republikken, 138-736
- Rekruttering
- Asan Medical Center - University of Ulsan College of Medicine
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Kontakt:
- Contact Person
- Telefonnummer: 82-2-3010-7282
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
DISEASE CHARACTERISTICS:
Biopsy-proven stage IIIA nonsquamous non-small cell lung cancer
- pN2 disease proven by mediastinoscopy
Meets any of the following criteria:
- Never smoked
- EGFR mutations (in exon 18, 19, or 21)*
- FISH positive for EGFR* NOTE: *Irrespective of smoking history
- Presence of at least 1 unidimensionally measurable lesion on thoracic CT scan, according to RECIST
- Feasible to undergo pneumonectomy or lobectomy
PATIENT CHARACTERISTICS:
Inclusion criteria:
- ECOG performance status 0-1
- FEV_1 ≥ 2.0 L in preoperative pulmonary function test
- Hemoglobin ≥ 9.0 g/dL
- WBC 4,000-12,000/μL
- ANC ≥ 1,500/μL
- Platelet count ≥ 100,000/mm³
- Total bilirubin ≤ 1.5 times upper limit of normal (ULN)
- Alkaline phosphatase ≤ 3.0 times ULN
- AST and ALT ≤ 3.0 times ULN
- Creatinine ≤ 1.5 times ULN
- Negative pregnancy test
Exclusion criteria:
- Severe complications or infections
- Pregnant or breast-feeding women
- Clinically significant heart disease
- Uncontrolled hepatitis, chronic liver disease, or diabetes mellitus
- Another active cancer except properly treated carcinoma in situ of the cervix or basal/squamous cell skin carcinoma
PRIOR CONCURRENT THERAPY:
- No prior radiotherapy, chemotherapy, hormone therapy, or target therapy
- No other concurrent systemic anticancer therapies, including experimental drugs, chemotherapy, immunotherapy, or radiotherapy
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Maskning: Ingen (Åben etiket)
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
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Svarprocent
|
Sekundære resultatmål
Resultatmål |
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Toksicitet
|
Samlet overlevelsesrate
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Fuldstændig resektionsrate
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Median disease-free survival
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Complete pathological response rate
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Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (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
Nøgleord
Yderligere relevante MeSH-vilkår
- Luftvejssygdomme
- Neoplasmer
- Lungesygdomme
- Neoplasmer efter sted
- Neoplasmer i luftvejene
- Thoracale neoplasmer
- Karcinom, bronkogent
- Bronkiale neoplasmer
- Lungeneoplasmer
- Karcinom, ikke-småcellet lunge
- Molekylære mekanismer for farmakologisk virkning
- Enzymhæmmere
- Antineoplastiske midler
- Proteinkinasehæmmere
- Gefitinib
Andre undersøgelses-id-numre
- CDR0000582623
- YONSEI-4-2006-0136
- ZENECA-YONSEI-4-2006-0136
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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