NCT01343914

Brief Summary

This retrospective observational study will analyse demographic, clinical and treatment-related data of patients with non-squamous non-small cell lung cancer (NSCLC) who had reached \>/= 9 months of progression-free survival after Avastin (bevacizumab)-based first-line therapy. Data will be collected for approximately 9 months.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
118

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2011

Shorter than P25 for all trials

Geographic Reach
1 country

33 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

First Submitted

Initial submission to the registry

April 12, 2011

Completed
16 days until next milestone

First Posted

Study publicly available on registry

April 28, 2011

Completed
1 month until next milestone

Study Start

First participant enrolled

June 1, 2011

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

November 2, 2016

Status Verified

November 1, 2016

Enrollment Period

6 months

First QC Date

April 12, 2011

Last Update Submit

November 1, 2016

Conditions

Non-Squamous Non-Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

  • Progression-free survival (>9 months) according to clinical phenotype

    approximately 9 months

Secondary Outcomes (2)

  • Overall survival

    approximately 9 months

  • Safety: Incidence of adverse events

    approximately 9 months

Study Arms (1)

Cohort

Eligibility Criteria

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

Non squamous NSCLC patients treated with bevacizumab-based first line therapy and PFS \>/= 9 months

You may qualify if:

  • Adult patients, \>/= 18 years of age
  • Non-squamous non-small cell lung cancer (NSCLC) treated with first-line Avastin-based therapy
  • Progression-free survival of \>/= 9 months reached

You may not qualify if:

  • N/A

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (33)

Unknown Facility

Alcoy, Alicante, 03804, Spain

Location

Unknown Facility

Alicante, Alicante, 3010, Spain

Location

Unknown Facility

Elche, Alicante, 03203, Spain

Location

Unknown Facility

Elda, Alicante, 03600, Spain

Location

Unknown Facility

Almería, Almeria, 04009, Spain

Location

Unknown Facility

Manacor, Balearic Islands, 07500, Spain

Location

Unknown Facility

Palma de Mallorca, Balearic Islands, 07012, Spain

Location

Unknown Facility

Barcelona, Barcelona, 08028, Spain

Location

Unknown Facility

Barcelona, Barcelona, 08041, Spain

Location

Unknown Facility

Barcelona, Barcelona, 08916, Spain

Location

Unknown Facility

Cáceres, Caceres, 10003, Spain

Location

Unknown Facility

San Sebastián de los Reyes, Guipuzcoa, 28702, Spain

Location

Unknown Facility

Jaén, Jaen, 23007, Spain

Location

Unknown Facility

Santiago de Compostela, La Coruña, 15706, Spain

Location

Unknown Facility

León, Leon, 24071, Spain

Location

Unknown Facility

Lugo, Lugo, 27004, Spain

Location

Unknown Facility

Madrid, Madrid, 28007, Spain

Location

Unknown Facility

Madrid, Madrid, 28033, Spain

Location

Unknown Facility

Madrid, Madrid, 28034, Spain

Location

Unknown Facility

Madrid, Madrid, 28040, Spain

Location

Unknown Facility

Madrid, Madrid, 28046, Spain

Location

Unknown Facility

Madrid, Madrid, 28050, Spain

Location

Unknown Facility

Madrid, Madrid, 28935, Spain

Location

Unknown Facility

Málaga, Malaga, 29010, Spain

Location

Unknown Facility

Murcia, Murcia, 30008, Spain

Location

Unknown Facility

Navarra, Navarre, 31008, Spain

Location

Unknown Facility

Pontevedra, Pontevedra, 36002, Spain

Location

Unknown Facility

Vigo, Pontevedra, 36312, Spain

Location

Unknown Facility

Seville, Sevilla, 41013, Spain

Location

Unknown Facility

Valencia, Valencia, 46015, Spain

Location

Unknown Facility

Valencia, Valencia, 46017, Spain

Location

Unknown Facility

Valencia, Valencia, 46026, Spain

Location

Unknown Facility

Zaragoza, Zaragoza, 50009, Spain

Location

Study Officials

  • Clinical Trials

    Hoffmann-La Roche

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

April 12, 2011

First Posted

April 28, 2011

Study Start

June 1, 2011

Primary Completion

December 1, 2011

Study Completion

December 1, 2011

Last Updated

November 2, 2016

Record last verified: 2016-11

Locations

ES(33)