NCT04640935

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
320

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2019

Shorter than P25 for all trials

Geographic Reach
1 country

15 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2019

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 5, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 5, 2020

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

November 9, 2020

Completed
14 days until next milestone

First Posted

Study publicly available on registry

November 23, 2020

Completed
Last Updated

November 23, 2020

Status Verified

November 1, 2020

Enrollment Period

8 months

First QC Date

November 9, 2020

Last Update Submit

November 20, 2020

Conditions

Keywords

Non-small cell lung cancersPaclitaxelBevacizumab

Outcome Measures

Primary Outcomes (1)

  • Progression-free survival

    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

Secondary Outcomes (8)

  • Drugs administration dosage description

    Up to 12 months

  • Objective response rate and control rate

    Up to 12 months

  • Overall survival Rate

    Up to 12 months

  • Objective Response Rate

    Up to 12 months

  • Progression-Free Survival Rate

    Up to 12 months

  • +3 more secondary outcomes

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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.

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (15)

Hôpital Ambroise Paré AP-HP

Boulogne-Billancourt, France

Location

Centre Hospitalier Universitaire Brest

Brest, France

Location

Centre Hospitalier Métropole Savoie

Chambéry, France

Location

Centre Hospitalier Intercommunal de Créteil

Créteil, France

Location

Centre Hospitalier Universitaire Grenoble Alpes

Grenoble, France

Location

Centre Hospitalier de Versailles André Mignot

Le Chesnay, France

Location

Centre Hospitalier Universitaire de Lille

Lille, France

Location

Centre Léon Bérard Lyon

Lyon, France

Location

Hospices Civils de Lyon

Lyon, France

Location

Centre Hospitalier François Quesnay

Mantes-la-Jolie, France

Location

Centre Hospitalier Annecy Genevois

Metz-Tessy, 74374, France

Location

Institut Curie

Paris, France

Location

Institut Curie Saint Cloud

Saint-Cloud, France

Location

Institut de Cancérologie Lucien Neuwirth

Saint-Etienne, France

Location

Hôpital Foch

Suresnes, France

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Chantal Decroisette

    CH Annecy Genevois

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 9, 2020

First Posted

November 23, 2020

Study Start

October 1, 2019

Primary Completion

June 5, 2020

Study Completion

June 5, 2020

Last Updated

November 23, 2020

Record last verified: 2020-11

Locations