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Efficacy and Safety of Albumin Paclitaxel Combined With Cisplatin Chemoradiotherapy for Non-resectable Stage III NSCLC

22. februar 2020 oppdatert av: Guizhou Medical University

Department of Oncology, Affiliated Hospital of Guizhou Medical University

Non-resectable stage III non-small cell lung cancer is recommended for concurrent chemoradiotherapy. Paclitaxel and platinum are commonly used in chemotherapy regimens. The aim of this study was to investigate whether paclitaxel albumin combined with cisplatin combined with three-dimensional primary radiotherapy could improve short-term efficacy, local progression-free survival, and reduce treatment-related toxicity. To determine whether paclitaxel albumin combined with cisplatin regimen can be used as a first-line treatment for stage III non-small cell lung cancer with concurrent primary thoracic radiotherapy

Studieoversikt

Detaljert beskrivelse

Control group: Paclitaxel 175 mg/m2 was injected into saline solution on the first day. Cisplatin 75 mg/m2 was given intravenously for 2-3 days (2-4 days), carboplatin 300 mg/m2 and 2 days. (Because toxicity and heart problems can replace DDP)]Repeated every 3-4 weeks for 4 consecutive cycles (21-28 days/cycle, minimum 2 cycles). In the experimental group, albumin paclitaxel 40 mg/m2/week was injected into saline at the same time as radiotherapy, once a week. Cisplatin 75 mg/m2 was given intravenously for 2-3 days (2-4 days), carboplatin 300 mg/m2 and 2 days. (Because toxicity and heart problems can replace DDP)] Repeat every 3-4 weeks for 4 consecutive cycles (21-28 days/cycle, minimum 2 cycles). Three-dimensional radiotherapy: intensity-modulated radiotherapy (IMRT) or rotational intensity-modulated radiation therapy (VMAT) segmented dose: primary focus and mediastinal metastatic lymph nodes; segmented mode: continuous accelerated hypersegmentation Dose: DTGTV: > 60Gy treatment sequence: Chemotherapy started within one week after completion of pre-treatment evaluation. Radiotherapy for primary thoracic tumors was performed simultaneously on the first day of chemotherapy. Chemotherapy effectiveness was evaluated by radiological examination within one week after the completion of the second cycle of chemotherapy.

Studietype

Intervensjonell

Registrering (Forventet)

68

Fase

  • Ikke aktuelt

Kontakter og plasseringer

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

Studiesteder

    • Guizhou
      • Guiyang, Guizhou, Kina, 550001
        • Affiliated Hospital of Guizhou Medical University

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 80 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  • Patients with NSCLC confirmed by pathology or cytology; clinical stage III [AJCC 8th Edition stage];
  • Informed consent signed before treatment (radiotherapy, chemotherapy);
  • no contraindication of radiotherapy and chemotherapy; .IMRT or VMAT technology is required to achieve the prescription dose of primary tumor (DTGTV): > 60Gy, normal lung in the design of radiotherapy plan.
  • (Total Lung Volume minus GTV Volume) V20 < 32% were randomly enrolled in the study. [Planning Assessment: Prescription dose includes 100% GTV, 90% .prescription dose includes 98%~100% PTV] [Age 18-80 years old, body condition score ECOG0-2 or KPS (>70) ];
  • [Subjects had no major organ dysfunction, blood routine, lung, liver and kidney. With normal function and cardiac function, laboratory tests must meet the following requirements: leukocyte (>4.0 *109/L), neutrophil (>2.0 *109/L), platelet (>100 *109/L) and hemoglobin (>100 g/L). Liver function: normal range. Renal function: normal range .Lung function: FEV1 > 50%, mild to moderate lung function impairment. _Patients have good compliance with the treatment and follow-up.

Exclusion Criteria:

  • Pathological types, stages and survival status of patients who did not meet the criteria for enrollment
  • Patients with uncontrollable hypertension, diabetes mellitus, unstable angina, history of myocardial infarction or symptomatic congestive heart failure or uncontrollable arrhythmia in the past 12 months; .Clinically diagnosed valvular disease; active period of bacterial, fungal or viral infections; mental disorders; and severe heart failure.
  • Pulmonary impairment; Pregnancy and lactation patients;
  • Patients with a history of active malignancies other than small cell lung cancer before admission;
  • Patients with non-melanoma skin basal cell carcinoma, cervical cancer in situ, and cured early prostate cancer except; .Allergic constitution and known or suspected drug allergy in any study. .Patients without alternative drugs, patients with poor compliance, and researchers do not consider it appropriate to participate in this study.

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: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Enkelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Albumin paclitaxel

Albumin paclitaxel 40mg/m2/week was injected into normal saline at the same time as radiotherapy, once a week. Cisplatin 75 mg/m2 was given intravenously for 2-3 days , carboplatin 300 mg/m2 and 2 days. (Because toxicity and heart problems can replace DDP)] Repeat every cycle (21-28 days/cycle, minimum 2 cycles).

Three-dimensional radiotherapy:

intensity-modulated radiotherapy (IMRT) or rotational intensity-modulated radiation therapy (VMAT) segmented dose: primary focus and mediastinal metastatic lymph nodes; segmented mode: continuous accelerated hypersegmentation; Dose: DTGTV: > 60 Gy

Non-resectable stage III non-small cell lung cancer is recommended for concurrent chemoradiotherapy. Paclitaxel and platinum are commonly used in chemotherapy regimens. The aim of this study was to investigate whether paclitaxel albumin combined with cisplatin combined with three-dimensional primary radiotherapy could improve short-term efficacy, local progression-free survival, and reduce treatment-related toxicity. To determine whether paclitaxel albumin combined with cisplatin regimen chemotherapy can be used as a first-line treatment for stage III non-small cell lung cancer with concurrent primary thoracic radiotherapy.
Andre navn:
  • Albumin paklitaksel
Aktiv komparator: Paclitaxel

Paclitaxel 175 mg/m2 was injected into saline solution on the first day. Cisplatin 75 mg/m2 was given intravenously for 2-3 days , carboplatin 300 mg/m2 and on the second day. (Because toxicity and heart problems can replace DDP)]Repeated every cycle (21-28 days/cycle, minimum 2 cycles).

Three-dimensional radiotherapy:

intensity-modulated radiotherapy (IMRT) or rotational intensity-modulated radiation therapy (VMAT) segmented dose: primary focus and mediastinal metastatic lymph nodes; segmented mode: continuous accelerated hypersegmentation; Dose: DTGTV: > 60 Gy

Non-resectable stage III non-small cell lung cancer is recommended for concurrent chemoradiotherapy. Paclitaxel and platinum are commonly used in chemotherapy regimens. The aim of this study was to investigate whether paclitaxel albumin combined with cisplatin combined with three-dimensional primary radiotherapy could improve short-term efficacy, local progression-free survival, and reduce treatment-related toxicity. To determine whether paclitaxel albumin combined with cisplatin regimen chemotherapy can be used as a first-line treatment for stage III non-small cell lung cancer with concurrent primary thoracic radiotherapy.
Andre navn:
  • Albumin paklitaksel

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
ORR
Tidsramme: 2 years
Efficacy of Concurrent chemoradiotherapy
2 years

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Side effection
Tidsramme: 2 years
bone marrow suppression, hepatic and renal toxicity, cardiac toxicity, radiation pneumonia and other toxic and side effects caused by treatment
2 years

Samarbeidspartnere og etterforskere

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

Etterforskere

  • Hovedetterforsker: Bing Lu, Bachelor, Affiliated Hospital of Guizhou Medical University

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. september 2019

Primær fullføring (Forventet)

30. september 2021

Studiet fullført (Forventet)

30. oktober 2021

Datoer for studieregistrering

Først innsendt

14. september 2019

Først innsendt som oppfylte QC-kriteriene

22. februar 2020

Først lagt ut (Faktiske)

25. februar 2020

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

25. februar 2020

Siste oppdatering sendt inn som oppfylte QC-kriteriene

22. februar 2020

Sist bekreftet

1. juli 2019

Mer informasjon

Begreper knyttet til denne studien

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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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