Lung CancerNCT00721981
An Evaluation of the Clinical Treatment and Patient Values and Preferences of Patients Suffering From Advanced Non-small Cell Lung Cancer (NSCLC) Undergoing Chemotherapy
An observational study of Lung Cancer and Non-small Cell Lung Cancer, run by AstraZeneca at 8 sites in Germany.
Trial summary
The main purpose of this study is the identification, description, and segmentation of non-small cell lung cancer (NSCLC) patients based on their value appraisal of treatment outcomes and all intermediate states of health, to obtain patient preferences in direct correlation with clinical data from patients suffering… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer, Non-small Cell Lung Cancer
- How many people
- 120 participants
- Where
- 8 sitesGermany
- Study dates
- Apr 2009to Oct 2009
- 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: Patients suffering from non-small cell lung cancer (NSCLC) (stage IIIb and IV) undergoing chemotherapy, who are in transition from 1st to 2nd line treatment.
Who may be able to join
- Patients suffering from non-small cell lung cancer (NSCLC) with clinical stage IIIB and IV tumours
- Patients with one chemotherapy regimen (first line treatment) (adjuvant chemotherapy following surgery is also regarded as first line treatment)
- Patients who are in transition from first to second line treatment
- Patients who signed an informed consent
Who cannot join
- Chemotherapy naïve patients
- Patients ever enrolled in clinical studies treating non-small cell lung cancer (NSCLC) with chemotherapy (during 1st and 2nd line chemotherapy)
- Patients who ever had chemotherapy for an indication other than NSCLC
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Germany8 sites
Research Site
Berlin
Research Site
Essen
Research Site
Heidelberg
Research Site
Hemer
Research Site
Karlsruhe
Research Site
Löwenstein
Research Site
München
Research Site
Trier
About this study
Official title: A Non-interventional Study for Evaluation of the Clinical Treatment and Patient Values and Preferences of Patients Suffering From Advanced Non-small Cell Lung Cancer (NSCLC) Undergoing Chemotherapy. With Special Focus on Patients Who Are in Transition From First Line to Second Line Treatment
The main purpose of this study is the identification, description, and segmentation of non-small cell lung cancer (NSCLC) patients based on their value appraisal of treatment outcomes and all intermediate states of health, to obtain patient preferences in direct correlation with clinical data from patients suffering from NSCLC (stage IIIB / IV) who are in transition from 1st to 2nd line treatment, and to gain utility scores by health state derived from patients' perceived value and taken from their perspective.
- Conditions
- Lung Cancer, Non-small Cell Lung Cancer
- Keywords
- patient preference, oncology, chemotherapy, NSCLC
- Medical subject headings
- Lung Neoplasms, Carcinoma, Non-Small-Cell Lung, Patient Preference, Neoplasms
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 |
|---|---|---|
| 1 | Regular treatment for non-small cell lung cancer (NSCLC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
To obtain patient preferences in direct correlation with clinical data from patients suffering from NSCLC stage IIb/IV who are in transition from 1st line to 2nd line treatment
Measured: once only, 4-6 weeks after switch from 1st to 2nd line chemotherapy
Secondary outcomes (2)
current medical practice treatment objectives and modalities side effects
Measured: once only, 4-6 weeks after switch from 1st to 2nd line chemotherapy
socioeconomic status and demographics patients' perception of their health status and treatment patient values and patient preferences
Measured: once only, 4-6 weeks after switch from 1st to 2nd line chemotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2008 (estimated)
- Study startApr 2009
- Study completionOct 2009
Why it stopped: Low Recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Christopher Teale, Study director, AstraZeneca UK Limited, Alderley House, Alderley Park, Macclesfield SK10 4TF, Cheshire, United Kingdom, Phone: +44 1625 516549 Fax: +44 1625 518982Oliver Fietz, PhD, Study chair, AstraZeneca GmbH, Tinsdaler Weg 18322880, Wedel, Germany, Phone: +49 (0) 4103 708-3096 Fax: +49 (0) 4103 708-7-3096Helge Bischoff, MD, Principal investigator, Thoraxklinik Heidelberg, gGmbH, Amalienstr. 5, 69126 Heidelberg, Germany, Phone: +49 (0) 6221 396-1304 Fax: +49 (0) 6221 396-1305
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00721981
- Sponsor's protocol ID
- NIS-ODE-DUM-2008/1
- Status last verified
- Dec 2010
- First submitted
- 23 Jul 2008
- Last updated
- 10 Dec 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Non-interventional Study for Evaluation of the Clinical Treatment and Patient Values and Preferences of Patients Suffering From Advanced Non-small Cell Lung Cancer (NSCLC) Undergoing Chemotherapy. With Special Focus on Patients Who Are in Transition From First Line to Second Line Treatment
- ClinicalTrials.gov ID
- NCT00721981
- Acronym / sponsor ID
- NIS-ODE-DUM-2008/1
- Conditions
- Lung Cancer, Non-small Cell Lung Cancer
- Keywords
- patient preference, oncology, chemotherapy, NSCLC
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Low Recruitment
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Apr 2009
- Study completion
- Oct 2009 (actual)
- First posted
- 25 Jul 2008 (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.
The main purpose of this study is the identification, description, and segmentation of non-small cell lung cancer (NSCLC) patients based on their value appraisal of treatment outcomes and all intermediate states of health, to obtain patient preferences in direct correlation with clinical data from patients suffering from NSCLC (stage IIIB / IV) who are in transition from 1st to 2nd line treatment, and to gain utility scores by health state derived from patients' perceived value and taken from their perspective.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Regular treatment for non-small cell lung cancer (NSCLC) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients suffering from non-small cell lung cancer (NSCLC) (stage IIIb and IV) undergoing chemotherapy, who are in transition from 1st to 2nd line treatment.
Key inclusion criteria (4 listed)
- Patients suffering from non-small cell lung cancer (NSCLC) with clinical stage IIIB and IV tumours
- Patients with one chemotherapy regimen (first line treatment) (adjuvant chemotherapy following surgery is also regarded as first line treatment)
- Patients who are in transition from first to second line treatment
- Patients who signed an informed consent
Key exclusion criteria (3 listed)
- Chemotherapy naïve patients
- Patients ever enrolled in clinical studies treating non-small cell lung cancer (NSCLC) with chemotherapy (during 1st and 2nd line chemotherapy)
- Patients who ever had chemotherapy for an indication other than NSCLC
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
To obtain patient preferences in direct correlation with clinical data from patients suffering from NSCLC stage IIb/IV who are in transition from 1st line to 2nd line treatment
Time frame: once only, 4-6 weeks after switch from 1st to 2nd line chemotherapy
2 secondary outcomes
current medical practice treatment objectives and modalities side effects
Time frame: once only, 4-6 weeks after switch from 1st to 2nd line chemotherapy
socioeconomic status and demographics patients' perception of their health status and treatment patient values and patient preferences
Time frame: once only, 4-6 weeks after switch from 1st to 2nd line chemotherapy
Results and safety
The study was stopped early (reason given: Low Recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2010.
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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.
Christopher Teale study director
AstraZeneca UK Limited, Alderley House, Alderley Park, Macclesfield SK10 4TF, Cheshire, United Kingdom, Phone: +44 1625 516549 Fax: +44 1625 518982
Oliver Fietz, PhD study chair
AstraZeneca GmbH, Tinsdaler Weg 18322880, Wedel, Germany, Phone: +49 (0) 4103 708-3096 Fax: +49 (0) 4103 708-7-3096
Helge Bischoff, MD principal investigator
Thoraxklinik Heidelberg, gGmbH, Amalienstr. 5, 69126 Heidelberg, Germany, Phone: +49 (0) 6221 396-1304 Fax: +49 (0) 6221 396-1305
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Cancer and Non-small Cell Lung Cancer, run by AstraZeneca at 8 sites in Germany.
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 4 inclusion and 3 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: stopped early, as of the sponsor's last update on 10 Dec 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Germany. 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 was stopped early (reason given: Low Recruitment). Results are not available in the source record.
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?
To obtain patient preferences in direct correlation with clinical data from patients suffering from NSCLC stage IIb/IV who are in transition from 1st line to 2nd line treatment (time frame: once only, 4-6 weeks after switch from 1st to 2nd line chemotherapy). 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 10 Dec 2010.