- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT03119519
Local Non-salvage Radiotherapy for Synchronous Oligometastatic Non-small-cell Lung Cancer.
Local Non-salvage Radiotherapy for Synchronous Oligometastatic Non-small-cell Lung Cancer :A Multicenter,Randomized,Controlled,Phase 2 Study.
Studieoversikt
Status
Intervensjon / Behandling
Detaljert beskrivelse
Studietype
Registrering (Forventet)
Fase
- Fase 2
Kontakter og plasseringer
Studiesteder
-
-
Guangdong
-
Guangzhou, Guangdong, Kina, 510515
- Rekruttering
- Nanfang Hospital, Southern Medical University
-
Ta kontakt med:
- Xiaoxia Zhu, M.D.
- Telefonnummer: +862062787696
- E-post: zhuxx01@126.com
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- Male or female aged 18 to 70 years old;
- Histologically or cytologically confirmed non-small cell lung cancer;
- Stage IV patients with measurable primary tumor and distant metastases number ≤5;
- PS score 0-2;
- Have never received local or systemic anti-cancer treatment, including surgery (biopsy is allowed), first line chemotherapy, targeted therapy or immunotherapy;
- Life expectancy of >3 months;
- Organ function levels must meet the following requirements:
(1)Bone marrow: White blood cell (WBC)≥4.0G/L;neutrophile granulocyte (NEU)≥1.5G/L;platelets (PLT)≥100G/L; hemoglobin (HGB)≥9g/L; (2)Liver and kidney: total bilirubin (TBIL), aspartate aminotransferase (AST), alanine aminotransferase (ALT)≤2.0 × the upper limit of normal (ULN);creatinine≤1.5×ULN; 8.Patient must be willing and able to provide written informed consent.
Exclusion Criteria:
- The amount of metastatic focus >5;
- Patient can't tolerate chemotherapy or targeted therapy;
- Local or systemic anti-cancer treatment had been used for the primary foci and metastatic lymph nodes, including surgery (biopsy is allowed), first line chemotherapy, targeted therapy or immunotherapy;
- Previous or concurrent suffered from other malignancies;
- Concurrent with other serious disease that can not be controlled;
- Women who are breast-feeding or pregnant;
- Have an allergy to pemetrexed, cisplatin, taxanes, targeted medicine and contrast agent;
- Patients with poor obedience or researchers think that the patient may not be able to accomplish the whole trial.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Local Definitive Radiotherapy
Standard platinum-based doublet chemotherapy or EGFR-TKI (Gefitinib or Erlotinib) followed by 3D-CRT (three-dimensional conformal radiotherapy) or IMRT (intensity modulated radiotherapy) to primary thoracic foci or remediable oligometastatic focus.
|
three-dimensional conformal therapy or intensity modulated radiation therapy
Andre navn:
Standard platinum-based doublet chemotherapy or EGFR-TKI (Gefitinib or Erlotinib) alone, according to gene test.
Andre navn:
|
|
Aktiv komparator: No Local Definitive Radiotherapy
Standard platinum-based doublet chemotherapy or EGFR-TKI (Gefitinib or Erlotinib) alone, according to gene test.
|
Standard platinum-based doublet chemotherapy or EGFR-TKI (Gefitinib or Erlotinib) alone, according to gene test.
Andre navn:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Progression-free Survival (PFS)
Tidsramme: 5 years
|
Refers to the time from randomization to disease progression or death.
|
5 years
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Local tumor control
Tidsramme: up to 5 years
|
From time of randomization to time of progression or death(according to RECIST v1.1 [)
|
up to 5 years
|
|
Oligometastatic foci control
Tidsramme: up to 5 years
|
From time of first chemotherapy or targeted therapy to time of progression or death(according to RECIST v1.1)
|
up to 5 years
|
|
Thoracic Progression Free Survival
Tidsramme: up to 5 years
|
From time of first chemotherapy or targeted therapy to time of progression or death
|
up to 5 years
|
|
Overall Survival
Tidsramme: up to 5 years
|
From time of first chemotherapy or targeted therapy to date of death
|
up to 5 years
|
Samarbeidspartnere og etterforskere
Etterforskere
- Studiestol: Xiaoxia Zhu, Nanfang Hospital of Southern Medical University
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Forventet)
Studiet fullført (Forventet)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- LC2019ZD009
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
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. .