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Paclitaxel in Combination With Bevacizumab in Patients With Stage IV NSCLC. (AVATAX)

20. november 2020 oppdatert av: Centre Hospitalier Annecy Genevois

Retrospective Multicenter Study of Paclitaxel in Combination With Bevacizumab in Patients With Stage IV Non-small Cell Lung Cancer (NSCLC).

The aim of the study is to evaluate the paclitaxel-bevacizumab combination retrospectively and multicenter in current practice, with subgroup analyses of the following patients: patients who have previously received immunotherapy, patients with an EGFR or ALK oncogenic addiction pathway, patients who have previously received taxanes or anti-angiogenic agents.

Studieoversikt

Status

Fullført

Detaljert beskrivelse

Lung and bronchopulmonary cancer is the leading cause of cancer death in France and worldwide. It is diagnosed at the metastatic stage from the outset in approximately 50% of cases. Non-small cell lung cancers (NSCLC) are the most frequent histological forms of lung cancer (approximately 85% of cases) with a predominance of the non-epidermal type.

The increase in the number of treatments available, improved supportive care and better patient selection have, in recent years, made it possible to expand the range of first-line chemotherapy treatments available at delà̀ and have contributed to the increase in overall survival (OS). As a result, nearly 80% of patients with metastatic NSCLC receive a second line of treatment. The main objective in these often symptomatic patients is a satisfactory tumor control rate with acceptable tolerability.

For a long time, the second-line reference chemotherapy has been docetaxel or pemetrexed as monotherapy with modest results. Alternative treatments such as the combination of paclitaxel (chemotherapy)-bevacizumab (anti-angiogenic monoclonal antibody) have been studied. Since 2010, by analogy with breast cancer and in the absence of therapeutic alternatives, the paclitaxel-bevacizumab doublet has been used in non-epidermal stage IV NSCLC in France. The value of combining taxane chemotherapy with an anti-angiogenic molecule has been demonstrated in two Phase 3 clinical trials. Thus, this combination is an integral part of the possible treatments in 2nd line and beyond, registered since 2016 in the treatment guidelines for non-epidermal NSCLC.

The first-line therapeutic strategy will also be redefined in 2019 with the use of immunotherapy for a majority of patients. Subsequent treatment lines will be modified, with a focus on chemotherapy, in particular the paclitaxel-bevacizumab combination.

As this combination has been used in current practice for several years, and in view of the upcoming changes to the first and second line of NSCLC treatment, data on the efficacy and tolerance of this combination in real life are needed to guide our practices. Recent studies are also looking at the efficacy of chemotherapy, particularly taxane chemotherapy associated with an anti-angiogenic agent after a previous line including immunotherapy, with a favorable signal.

The aim of the study is to evaluate the paclitaxel-bevacizumab combination retrospectively and multicenter in current practice, with subgroup analyses of the following patients: patients who have previously received immunotherapy, patients with an EGFR or ALK oncogenic addiction pathway, patients who have previously received taxanes or anti-angiogenic agents.

Studietype

Observasjonsmessig

Registrering (Faktiske)

320

Kontakter og plasseringer

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

Studiesteder

      • Boulogne Billancourt, Frankrike
        • Hôpital Ambroise Paré AP-HP
      • Brest, Frankrike
        • Centre Hospitalier Universitaire Brest
      • Chambéry, Frankrike
        • Centre Hospitalier Metropole Savoie
      • Créteil, Frankrike
        • Centre Hospitalier Intercommunal de Créteil
      • Grenoble, Frankrike
        • Centre Hospitalier Universitaire Grenoble Alpes
      • Le Chesnay, Frankrike
        • Centre Hospitalier de Versailles André Mignot
      • Lille, Frankrike
        • Centre Hospitalier Universitaire de Lille
      • Lyon, Frankrike
        • Hospices Civils de Lyon
      • Lyon, Frankrike
        • Centre Léon Bérard Lyon
      • Mantes-la-Jolie, Frankrike
        • Centre Hospitalier François Quesnay
      • Metz-Tessy, Frankrike, 74374
        • Centre Hospitalier Annecy Genevois
      • Paris, Frankrike
        • Institut Curie
      • Saint-Cloud, Frankrike
        • Institut Curie Saint Cloud
      • Saint-Étienne, Frankrike
        • Institut de Cancérologie Lucien Neuwirth
      • Suresnes, Frankrike
        • Hôpital Foch

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 og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Prøvetakingsmetode

Sannsynlighetsprøve

Studiepopulasjon

The study will include all eligible patients who started paclitaxel-bevacizumab between January 1, 2010 and May 1, 2018. The number of patients is estimated to be approximately 200.

Beskrivelse

Inclusion Criteria:

  • At least 18 years old;
  • Histologically or cytologically confirmed diagnosis of non-epidermal NSCLC;
  • Advanced stage IV disease at the start of treatment with paclitaxel-bevacizumab according to TNM 7/8th edition classification;
  • Treatment with paclitaxel-bevacizumab received as second-line therapy or beyond, in a clinical trial or not;
  • Alive patients not opposed to the use of their data

Exclusion Criteria:

  • Patient under guardianship or curatorship at the date of the study ;
  • Patients alive at the time of the study who are opposed to the use of their data
  • Opposition to the use of their data expressed during the lifetime of patients who died at the time of the study.

Studieplan

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

Hvordan er studiet utformet?

Designdetaljer

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Progression-free survival
Tidsramme: Up to 12 months
Progression-free survival with paclitaxel-bevacizumab, i.e., the time from the start of paclitaxel-bevacizumab treatment to cancer progression, estimated at 12 months in the general population.
Up to 12 months

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Drugs administration dosage description
Tidsramme: Up to 12 months
Description of the different monthly drug administration regimens
Up to 12 months
Objective response rate and control rate
Tidsramme: Up to 12 months
Objective response rate and control rate according to RECIST 1.1 criteria in the general population
Up to 12 months
Overall survival Rate
Tidsramme: Up to 12 months
Overall survival, assessed on the whole population
Up to 12 months
Objective Response Rate
Tidsramme: Up to 12 months

Objective Response Rate in the following subgroups:

  • patients treated after immunotherapy and especially immediately after immunotherapy;
  • Patients with an oncogenic EGFR or ALK addiction pathway;
  • Patients previously treated with taxanes;
  • Patients previously treated with anti-angiogenic drugs;
Up to 12 months
Progression-Free Survival Rate
Tidsramme: Up to 12 months

Progression-Free Survival in the following subgroups:

  • patients treated after immunotherapy and especially immediately after immunotherapy;
  • Patients with an oncogenic EGFR or ALK addiction pathway;
  • Patients previously treated with taxanes;
  • Patients previously treated with anti-angiogenic drugs;
Up to 12 months
Disease Control Rate
Tidsramme: Up to 12 months

Disease Control in the following subgroups:

  • patients treated after immunotherapy and especially immediately after immunotherapy;
  • Patients with an oncogenic EGFR or ALK addiction pathway;
  • Patients previously treated with taxanes;
  • Patients previously treated with anti-angiogenic drugs;
Up to 12 months
Overall Survival Rate
Tidsramme: Up to 12 months

Overall Survival in the following subgroups:

  • Patients treated after immunotherapy and especially immediately after immunotherapy;
  • Patients with an oncogenic EGFR or ALK addiction pathway;
  • Patients previously treated with taxanes;
  • Patients previously treated with anti-angiogenic drugs;
Up to 12 months
Frequency of safety events
Tidsramme: Up to 12 months
Frequency of grade ≥3 adverse events and frequency of discontinuation of paclitaxel-bevacizumab for toxicity ;
Up to 12 months

Samarbeidspartnere og etterforskere

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

Samarbeidspartnere

Etterforskere

  • Hovedetterforsker: Chantal Decroisette, Ch Annecy Genevois

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. oktober 2019

Primær fullføring (Faktiske)

5. juni 2020

Studiet fullført (Faktiske)

5. juni 2020

Datoer for studieregistrering

Først innsendt

9. november 2020

Først innsendt som oppfylte QC-kriteriene

20. november 2020

Først lagt ut (Faktiske)

23. november 2020

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

23. november 2020

Siste oppdatering sendt inn som oppfylte QC-kriteriene

20. november 2020

Sist bekreftet

1. november 2020

Mer informasjon

Begreper knyttet til denne studien

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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