Non-Squamous Non-Small Cell Lung CancerNCT01358942
An Observational Study of Lung Cancer Related Symptoms and Disease Control Rate in Patients With Non-Small Cell Lung Cancer Receiving First-Line Platinum-Based Chemotherapy With or Without Avastin (Bevacizumab)
An observational study of Non-Squamous Non-Small Cell Lung Cancer, run by Hoffmann-La Roche at 37 sites in Spain.
Trial summary
This prospective observational study will evaluate the evolution of lung cancer related symptoms and their correlation with the disease control rate (complete response, partial response and stable disease) in patients with non-small cell lung cancer initiating first-line treatment with standard platinum-based… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Squamous Non-Small Cell Lung Cancer
- How many people
- 156 participants
- Where
- 37 sitesSpain
- Study dates
- May 2011to Nov 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Non-small cell lung cancer patients initiating treatment with platinum-based chemotherapy +/- bevacizumab
Who may be able to join
- Adult patients, >/= 18 years of age
- Histologically or cytologically confirmed non-small cell lung cancer
- Initiating first-line treatment with standard platinum-based chemotherapy, with or without bevacizumab
Who cannot join
- Contraindications to the use of platinum-based chemotherapy
Trial locations and contacts
37 sites in 1 country.
37 sites in 1 country
Spain37 sites
Study site
Alcalá de Henares, Madrid, 28805
Study site
Alcoy, Alicante, 03804
Study site
Alicante, Alicante, 3010
Study site
Barcelona, Barcelona, 08006
Study site
Barcelona, Barcelona, 08017
Study site
Barcelona, Barcelona, 08906
Study site
Bilbao, Vizcaya, 48013
Study site
Castellon, Castellon, 12002
Study site
Donostia / San Sebastian, Guipuzcoa, 20080
Study site
Elche, Alicante, 03203
Study site
Elda, Alicante, 03600
Study site
Jaén, Jaen, 23007
Study site
Jerez de la Frontera, Cadiz, 11407
Study site
Logroño, La Rioja, 26006
Study site
Madrid, Madrid, 28031
Study site
Madrid, Madrid, 28033
Study site
Madrid, Madrid, 28040
Study site
Madrid, Madrid, 28041
Study site
Madrid, Madrid, 28046
Study site
Madrid, Madrid, 28050
Study site
Mahon, Balearic Islands, 07703
Study site
Málaga, Malaga, 29010
Study site
Melilla, Malaga, 52005
Study site
Navarra, Navarre, 31008
Study site
Oviedo, Principality of Asturias, 33011
Study site
Palma de Mallorca, Balearic Islands, 07012
Study site
Palma de Mallorca, Balearic Islands, 07014
Study site
Pamplona, Navarre, 31006
Study site
Pamplona, Navarre, 31008
Study site
Pontevedra, Pontevedra, 36002
Study site
Sagunto, Valencia, 46520
Study site
Segovia, Segovia, 40002
Study site
Tudela, Navarre, 46010
Study site
Valencia, Valencia, 46015
Study site
Valencia, Valencia, 46017
Study site
Vitoria-Gasteiz, Alava, 01009
Study site
Xàtiva, Valencia, 46800
About this study
Official title: Observational, Epidemiological and Non Interventional Study Evaluating the Evolution of Lung Cancer Related Symptoms and Its Correlation With Disease Control Rate in Patients With Non-Small Cell Lung Cancer (NSCLC) Initiating First-line Treatment With Platinum Based Standard Chemotherapy.
This prospective observational study will evaluate the evolution of lung cancer related symptoms and their correlation with the disease control rate (complete response, partial response and stable disease) in patients with non-small cell lung cancer initiating first-line treatment with standard platinum-based chemotherapy with or without Avastin (bevacizumab). Data will be collected from each patient at baseline and after 4-6 cycles of chemotherapy.
- Conditions
- Non-Squamous Non-Small Cell Lung Cancer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cohort | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in lung cancer related symptoms (LCSS questionnaire)
Measured: up to approximately 6 months (4-6 cycles of chemotherapy)
Correlation of lung cancer related symptoms and disease control rate (complete response, partial response, stable disease according to RECIST criteria)
Measured: approximately 2 years
Secondary outcomes (1)
Frequency/severity of lung cancer related symptoms (LCSS questionnaire)
Measured: approximately 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2011 (estimated)
- Study startMay 2011
- Primary completionNov 2012
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Squamous Non-Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 156 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01358942
- Sponsor's protocol ID
- ML25493
- Status last verified
- Nov 2016
- First submitted
- 20 May 2011
- Last updated
- 2 Nov 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational, Epidemiological and Non Interventional Study Evaluating the Evolution of Lung Cancer Related Symptoms and Its Correlation With Disease Control Rate in Patients With Non-Small Cell Lung Cancer (NSCLC) Initiating First-line Treatment With Platinum Based Standard Chemotherapy.
- ClinicalTrials.gov ID
- NCT01358942
- Acronym / sponsor ID
- ML25493
- Conditions
- Non-Squamous Non-Small Cell Lung Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 156 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- May 2011
- Primary completion
- Nov 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 24 May 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This prospective observational study will evaluate the evolution of lung cancer related symptoms and their correlation with the disease control rate (complete response, partial response and stable disease) in patients with non-small cell lung cancer initiating first-line treatment with standard platinum-based chemotherapy with or without Avastin (bevacizumab). Data will be collected from each patient at baseline and after 4-6 cycles of chemotherapy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cohort | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Non-small cell lung cancer patients initiating treatment with platinum-based chemotherapy +/- bevacizumab
Key inclusion criteria (3 listed)
- Adult patients, >/= 18 years of age
- Histologically or cytologically confirmed non-small cell lung cancer
- Initiating first-line treatment with standard platinum-based chemotherapy, with or without bevacizumab
Key exclusion criteria (1 listed)
- Contraindications to the use of platinum-based chemotherapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in lung cancer related symptoms (LCSS questionnaire)
Time frame: up to approximately 6 months (4-6 cycles of chemotherapy)
Correlation of lung cancer related symptoms and disease control rate (complete response, partial response, stable disease according to RECIST criteria)
Time frame: approximately 2 years
1 secondary outcome
Frequency/severity of lung cancer related symptoms (LCSS questionnaire)
Time frame: approximately 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Trials study director
Hoffmann-La Roche
37 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-Squamous Non-Small Cell Lung Cancer, run by Hoffmann-La Roche at 37 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 37 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in lung cancer related symptoms (LCSS questionnaire) (time frame: up to approximately 6 months (4-6 cycles of chemotherapy)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2016.