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)
This study has been completed.
Sponsor:
Hoffmann-La Roche
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01358942
First received: May 20, 2011
Last updated: May 13, 2013
Last verified: May 2013
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Purpose
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.
| Condition |
|---|
|
Non-Small Cell Lung Cancer |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| 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. |
Resource links provided by NLM:
Further study details as provided by Hoffmann-La Roche:
Primary Outcome Measures:
- Change in lung cancer related symptoms (LCSS questionnaire) [ Time Frame: up to approximately 6 months (4-6 cycles of chemotherapy) ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Frequency/severity of lung cancer related symptoms (LCSS questionnaire) [ Time Frame: approximately 2 years ] [ Designated as safety issue: No ]
| Enrollment: | 156 |
| Study Start Date: | May 2011 |
| Study Completion Date: | April 2013 |
| Primary Completion Date: | April 2013 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
| Cohort |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Study Population
Non-small cell lung cancer patients initiating treatment with platinum-based chemotherapy +/- bevacizumab
Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- Contraindications to the use of platinum-based chemotherapy
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01358942
Locations
| Spain | |
| Alcala de Henares, Spain, 28805 | |
| Alcoy, Spain, 3804 | |
| Alicante, Spain, 03010 | |
| Barcelona, Spain, 08017 | |
| Barcelona, Spain, 08006 | |
| Barcelona, Spain, 08906 | |
| Bilbao, Spain, 48013 | |
| Castellon, Spain, 12002 | |
| Elche, Spain, 03203 | |
| Elda, Spain, 03600 | |
| Jaen, Spain, 23007 | |
| Jerez de La Frontera, Spain, 11407 | |
| Logroño, Spain, 26006 | |
| Madrid, Spain, 28046 | |
| Madrid, Spain, 28050 | |
| Madrid, Spain, 28041 | |
| Madrid, Spain, 28031 | |
| Madrid, Spain, 28033 | |
| Madrid, Spain, 28040 | |
| Mahon, Spain, 07703 | |
| Malaga, Spain, 29010 | |
| Melilla, Spain, 52005 | |
| Navarra, Spain, 31008 | |
| Palma de Mallorca, Spain, 07012 | |
| Palma de Mallorca, Spain, 07014 | |
| Pamplona, Spain, 31006 | |
| Pamplona, Spain, 31008 | |
| Pontevedra, Spain, 36002 | |
| Sagunto, Spain, 46520 | |
| San Sebastian, Spain, 20080 | |
| Segovia, Spain, 40002 | |
| Tudela, Spain, 46010 | |
| Valencia, Spain, 46017 | |
| Valencia, Spain, 46015 | |
| Vitoria, Spain, 01009 | |
| Xativa, Spain, 46800 | |
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
| Study Director: | Clinical Trials | Hoffmann-La Roche |
More Information
No publications provided
| Responsible Party: | Hoffmann-La Roche |
| ClinicalTrials.gov Identifier: | NCT01358942 History of Changes |
| Other Study ID Numbers: | ML25493 |
| Study First Received: | May 20, 2011 |
| Last Updated: | May 13, 2013 |
| Health Authority: | Spain: Ministry of Health |
Additional relevant MeSH terms:
|
Carcinoma, Non-Small-Cell Lung Lung Neoplasms Carcinoma, Bronchogenic Bronchial Neoplasms Respiratory Tract Neoplasms |
Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases |
ClinicalTrials.gov processed this record on May 19, 2013