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

22 februari 2020 uppdaterad 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

Studieöversikt

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Förväntat)

68

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

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

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år till 80 år (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Enda

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: 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.
Andra namn:
  • Albumin paklitaxel
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.
Andra namn:
  • Albumin paklitaxel

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
ORR
Tidsram: 2 years
Efficacy of Concurrent chemoradiotherapy
2 years

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Side effection
Tidsram: 2 years
bone marrow suppression, hepatic and renal toxicity, cardiac toxicity, radiation pneumonia and other toxic and side effects caused by treatment
2 years

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Utredare

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

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

1 september 2019

Primärt slutförande (Förväntat)

30 september 2021

Avslutad studie (Förväntat)

30 oktober 2021

Studieregistreringsdatum

Först inskickad

14 september 2019

Först inskickad som uppfyllde QC-kriterierna

22 februari 2020

Första postat (Faktisk)

25 februari 2020

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

25 februari 2020

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

22 februari 2020

Senast verifierad

1 juli 2019

Mer information

Termer relaterade till denna studie

Plan för individuella deltagardata (IPD)

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Läkemedels- och apparatinformation, studiedokument

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Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

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