- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01746277
Study of Chemotherapy Sequenced by or Combined With EGFR-TKIs for NSCLC Patients Failed to EGFR-TKIs Therapy
A Phase Ⅱ Randomized Controlled Trial to Compare Chemotherapy Sequenced by EGFR-TKIs and Chemotherapy Combined With EGFR-TKIs for Advanced or Metastatic NSCLC Patients Failed to EGFR-TKIs Therapy
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Responses to EGFR-TKIs are quiet dramatic and durable, especially in patients with EGFR gene classic mutations, such as 19 deletion or 21 leucine 858 arginine(L858R). However, most patients with NSCLC who respond to EGFR-TKIs eventually experience progression of disease after approximately 12 months. The lack of an established therapeutic option for NSCLC patients who have progressive disease after EGFR-TKIs failure poses a great challenge to physicians in terms of how best to manage this growing group of lung cancer patients.
In clinical practice some of the initially EGFR-TKI sensitive tumors which progressed evidence a striking increase in tumor volume within several weeks, after being taken off EGFR-TKI. This response is called "rebound phenomenon". Most experts still believe that these tumors continue to be "oncogene-addicted" to EGFR. So it is rational that EGFR-TKI combined with another chemotherapy regimen can be used to treat NSCLC after the failure of EGFR-TKI therapy.
However in some phase Ⅱclinical trials involved a few NSCLC patients who failed to EGFR-TKI therapy, another treatment mode, that is to say, at least one cytotoxic chemotherapy was used firstly then switched to EGFR-TKI therapy until progression of disease, was used and called reintroduction or retreatment of EGFR-TKI. Using this treatment mode, some investigators reported the partial remission (PR) and disease control rate (DCR) were observed in 21.7%-36% and 65.2%-86% NSCLC patients.
Undersøgelsestype
Tilmelding (Forventet)
Fase
- Fase 2
Kontakter og lokationer
Studiekontakt
- Navn: Mengzhao Wang, MD
- Telefonnummer: 010-69155039
- E-mail: mengzhaowang@sina.com
Undersøgelse Kontakt Backup
- Navn: Jing Zhao, MD
- Telefonnummer: 010-69158206
- E-mail: zhaojing0@163.com
Studiesteder
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Beijing, Kina, 100730
- Rekruttering
- Department of Respiratory Medicne, Peking Union Medical Hospital
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Underforsker:
- Wei Zhong, MD
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Kontakt:
- Mengzhao Wang, MD
- Telefonnummer: 010-69155039
- E-mail: mengzhaowang@sina.com
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Kontakt:
- Jing Zhao, MD
- Telefonnummer: 010-69158206
- E-mail: zhaojing0@163.com
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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:
- age ≥ 18 years
- histologically and cytologically proven non-small cell bronchogenic carcinoma (sputum cytology alone was not acceptable)
- clinical stages ⅢB or Ⅳ
- recurrent or refractory disease following previous first-line chemotherapy regimens containing platinum and second-line EGFR-TKIs therapy
- partial remission (PR) or stable disease (SD) at least for 6 months during previous EGFR-TKI treatment
- at least one bidimensionally measurable or radiographically assessable lesion
- Eastern cooperative oncology group performance status (ECOG PS) ≤ 2
- life expectancy ≥ 12 weeks
- adequate hematological, renal, and hepatic functions
Exclusion Criteria:
- additional malignancies
- uncontrolled systemic disease
- any evidence of clinically active interstitial lung disease
- newly diagnosed central nervous system (CNS) metastasis and not treated by radiotherapy or surgery
- pregnancy or breast feeding phase
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Andet: combined group
combined group chemotherapy with docetaxel 75mg/m2 d1 or pemetrexed 500mg/m2 d1, every 3 weeks,at least 2 cycles and the maximal cycle is 6 depending on disease evaluation and patient's physical condition combined with gefitinib 250mg once per day from the start day of chemotherapy until disease progression or intolerable side effects.
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chemotherapy with docetaxel 75mg/m2 d1 or pemetrexed 500mg/m2 d1, every 3 weeks,at least 2 cycles and the maximal cycle is 6 depending on disease evaluation and patient's physical condition combined with gefitinib 250mg once per day from the start day of chemotherapy until disease progression or intolerable side effects.
Andre navne:
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Andet: sequenced group
sequenced group chemotherapy with docetaxel 75mg/m2 d1 or pemetrexed 500mg/m2 d1, every 3 weeks,at least 2 cycles and the maximal cycles is 6 depending on disease evaluation or patient's physical condition sequenced by gefitinib 250mg once per day until disease progression or intolerable side effects.
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sequenced group chemotherapy with docetaxel 75mg/m2 d1 or pemetrexed 500mg/m2 d1, every 3 weeks,at least 2 cycles and the maximal cycles is 6 depending on disease evaluation or patient's physical condition sequenced by gefitinib 250mg once per day until disease progression or intolerable side effects.
Andre navne:
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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progressionsfri overlevelse
Tidsramme: op til 52 uger (ca. et år)
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Fra randomiseringsdatoen til datoen for første dokumenterede progression eller dødsdato uanset årsag, alt efter hvad der kom først, vurderet op til 52 uger.
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op til 52 uger (ca. et år)
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
objective response rate
Tidsramme: up to 9 weeks
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The objective response rate includes the complete remission and partial remission rate.
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up to 9 weeks
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overall survival
Tidsramme: up to 100 weeks
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From date of randomization until the date of death from any cause, assessed up to 100 weeks.
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up to 100 weeks
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the score of functional assessment of cancer treatment-lung(FACT-L)
Tidsramme: up to 100weeks
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FACL-L is assessed at different time points.(Date of randomization,1 week after chemotherapy,every cycle of chemotherapy,every month of EGFR-TKI maintain treatment,up to 100 weeks)
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up to 100weeks
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Number of participants with adverse events
Tidsramme: Participants will be followed for the duration of treatment, an expected average of 52 weeks.
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The adverse events are assessed by National Cancer Institute-Common Toxicity Criteria(version3.0) (NCI-CTC).
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Participants will be followed for the duration of treatment, an expected average of 52 weeks.
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Samarbejdspartnere og efterforskere
Efterforskere
- Ledende efterforsker: Mengzhao Wang, MD, Peking Union Medical College Hospital
Publikationer og nyttige links
Generelle publikationer
- Becker A, Crombag L, Heideman DA, Thunnissen FB, van Wijk AW, Postmus PE, Smit EF. Retreatment with erlotinib: Regain of TKI sensitivity following a drug holiday for patients with NSCLC who initially responded to EGFR-TKI treatment. Eur J Cancer. 2011 Nov;47(17):2603-6. doi: 10.1016/j.ejca.2011.06.046. Epub 2011 Jul 23.
- Oh IJ, Ban HJ, Kim KS, Kim YC. Retreatment of gefitinib in patients with non-small-cell lung cancer who previously controlled to gefitinib: a single-arm, open-label, phase II study. Lung Cancer. 2012 Jul;77(1):121-7. doi: 10.1016/j.lungcan.2012.01.012. Epub 2012 Feb 12.
- Li J, Hao X, Wang Y, Zhang X, Shi Y. [Clinical response to gefitinib retreatment of lung adenocarcinoma patients who benefited from an initial gefitinib therapy: a retrospective analysis]. Zhongguo Fei Ai Za Zhi. 2012 Jan;15(1):44-8. doi: 10.3779/j.issn.1009-3419.2012.01.09. Chinese.
- Watanabe S, Tanaka J, Ota T, Kondo R, Tanaka H, Kagamu H, Ichikawa K, Koshio J, Baba J, Miyabayashi T, Narita I, Yoshizawa H. Clinical responses to EGFR-tyrosine kinase inhibitor retreatment in non-small cell lung cancer patients who benefited from prior effective gefitinib therapy: a retrospective analysis. BMC Cancer. 2011 Jan 1;11:1. doi: 10.1186/1471-2407-11-1.
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
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
- Nukleinsyresyntesehæmmere
- Enzymhæmmere
- Antineoplastiske midler
- Tubulin modulatorer
- Antimitotiske midler
- Mitose modulatorer
- Proteinkinasehæmmere
- Folinsyreantagonister
- Docetaxel
- Gefitinib
- Pemetrexed
Andre undersøgelses-id-numre
- PUMCH S-462
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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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Boston Medical CenterNational Institute of Mental Health (NIMH)AfsluttetPost traumatisk stress syndromForenede Stater
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University of California, San FranciscoMount Zion Health Fund; Pritzker Family Foundation; Mental Insight FoundationAfsluttetDepression, UnipolarForenede Stater
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Shengjing HospitalRekruttering