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Concurrent EGFR-TKIs and Thoracic Radiation Therapy in Active EGFR Mutation for 1st Line Treatment of Stage IV NSCLC (CERTAIN)

19. desember 2018 oppdatert av: Jianguo Sun, Xinqiao Hospital of Chongqing

Concurrent EGFR-TKIs and Thoracic Radiation Therapy in EGFR Active Mutation for the First Line Treatment of Non-Small Cell Lung Cancer at Stage IV: A Single-arm, Open-label, Single Center, Phase II Trial.

This single-arm phase II study aims to study the efficacy of a possible first line treatment that combines epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKIs) with concurrent thoracic radiation therapy for stage IV non-small cell lung cancer (NSCLC) with active EGFR mutation, as well as assessing PFS, OS, tumor response, etc. to verify that this new combinational therapy can benefit short-term and long-term survival of the patients with advanced NSCLC.

Studieoversikt

Detaljert beskrivelse

Based on NCCN guideline of the epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKIs) such as erlotinib, gefitinib and icotinib as the first line treatment for advanced Non-Small Cell Lung Cancer (NSCLC), the efficacy of EGFR-TKIs in combination with thoracic radiotherapy as the first line treatment for stage IV NSCLC with active EGFR mutation remains unknown. In this single-arm phase II trial, we chose the subjects with stage IV harboring active EGFR mutation,who were treated by EGFR-TKIs combined with radiation therapy. The primary endpoint is 1-year rate of progression-free survival and the second endpoints are overall survival (OS), objective response rate and toxic and side effect. By evaluating them, we expect to find out the evidence that the combination therapy can benefit the short-term and long-term survival of the patients. Meanwhile, via the stratification analysis of tumor biomarker and immune index, we obtain the evidences for the benefits of comprehensive and individual treatment for advanced NSCLC.

Studietype

Intervensjonell

Registrering (Faktiske)

10

Fase

  • Fase 2

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

      • Chongqing, Kina, 400000
        • Xinqiao Hospital of Chongqing

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år til 75 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  1. ECOG performance status≤2;
  2. Cytologically or pathologically confirmed stage IV NSCLC ( controlled pleural effusion will be eligible) with active EGFR mutation;
  3. Estimated survival time more than 3 months;
  4. Age older than 18 years and under 75 years;
  5. Adequate bone marrow, hepatic, and renal function;AST and ALT≤2.5 times the highest reference value when not associated with hepatic metastases, or ≤5 times when hepatic metastases occur;
  6. Without history of therapy for primary and metastatic disease;
  7. With pleural effusion but can be controlled;
  8. Asymptomatic bone metastases without treatment;
  9. Based on fusion images of 4DCT MIP sketch tumors and lymph nodes, and limit the mean lung dose: V20≤25%,V30≤18%,MLD≤14Gy,V5≤60%;
  10. M1a or M1b for metastases, and the number of the distant lesions ≤10;
  11. Voluntary to participate in this clinical trial and sign the consent form.

Exclusion Criteria:

  1. Patients with serious functional damage of important organs;
  2. Patients diagnosed adequately with other malignant tumors;
  3. Pregnant or lactating women;
  4. Patients in an active period of acute or chronic infectious diseases;
  5. Patients who are allergic to any drugs or people with allergies;
  6. With brain metastases;
  7. With bone metastases needing radiotherapy;
  8. Patients who participate in other clinical trials concurrently;
  9. Uncontrolled pleural effusion which may intervene the radiotherapy to primary tumor in lung;
  10. The number of the distant lesions>10;
  11. Patients who are considered not eligible for the trial after evaluation by investigator.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: EGFR-TKIs combined with radiotherapy
EGFR-TKIs combined with concurrent thoracic radiotherapy. Receive oral erlotinib 150mg per day with concurrent thoracic radiotherapy, within 2 weeks, pGTV54~60Gy/27~30f/5.5~6w.
Beginning on day 2 of treatment, receive oral erlotinib 150mg per day.
From the beginning of EGFR-TKIs, within 2 weeks, receive concurrent thoracic radiotherapy, pGTV54~60Gy/27~30f/5.5~6w.
Andre navn:
  • thoracic radiation

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
1-year rate of progression-free survival
Tidsramme: one year after treatment, followed
1-year rate of progression-free survival
one year after treatment, followed

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Overall survival (OS)
Tidsramme: From the time of study enrollment until the date of death
Overall survival (OS)
From the time of study enrollment until the date of death
Objective response rate
Tidsramme: up to three years
Assessed by Response Evaluation Criteria in Solid Tumors (RECIST 1.1)
up to three years
Disease control rate
Tidsramme: up to three years
Assessed by Response Evaluation Criteria in Solid Tumors (RECIST 1.1)
up to three years
patients quality of life
Tidsramme: up to three years
Assessed by EORTC-QLQ C30
up to three years
Failure mode
Tidsramme: up to three years
The number of patients who failed the treatment of EGFR-TKIs with thoracic radiotherapy.
up to three years
Toxicities associated with combined erlotinib and concurrent thoracic radiotherapy. Assessed by Common Terminology Criteria for Adverse Events(CTCAE)
Tidsramme: up to three years
Assessed by Common Terminology Criteria for Adverse Events(CTCAE)
up to three years

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

1. april 2015

Primær fullføring (Faktiske)

1. juni 2018

Studiet fullført (Faktiske)

1. desember 2018

Datoer for studieregistrering

Først innsendt

16. januar 2015

Først innsendt som oppfylte QC-kriteriene

2. februar 2015

Først lagt ut (Anslag)

3. februar 2015

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

21. desember 2018

Siste oppdatering sendt inn som oppfylte QC-kriteriene

19. desember 2018

Sist bekreftet

1. desember 2018

Mer informasjon

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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