Non Small Cell Lung CancerNCT00419042
Elderly Dependent Patients With Non Small Cell Lung Cancer (NSCLC)
An observational study of Non Small Cell Lung Cancer, run by Groupe Francais De Pneumo-Cancerologie at 23 sites in France.
Trial summary
The purpose of this study is in non small-cell lung cancer stage IV et IIIB (T4 with pleural effusion) in elderly dependent patients with evaluation of the sequence Gemcitabine first line followed by Erlotinib when progression versus Erlotinib first line followed by Gemcitabine when progression Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Non Small Cell Lung Cancer
- What is being tested?
- TARCEVA and Gemzar
- Type of treatment
- Pill or oral medicine, Injection or infusion
- How many people
- 100 participants
- Where
- 23 sitesFrance
- Study dates
- Jul 2006to Mar 2010
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Patients with non small-cell lung cancer stage IV et IIIB (T4 with pleural effusion) in elderly dependent patients
Who may be able to join
- Age > 65
- Comorbidities score, PS and frailty score according to table 1
- No dementia, faecal or urinary incontinence, repeated falls
- ADL = 0, IADL = 0-1
- Life expectancy at least 12 weeks
- Creatinin clearance > = 30 ml/mn (according to Cockcrofts-Gault formula)
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- Competency to give written informed consent
- Haematological functions as follows : neutrophiles count > 1.5 x 109/l and platelets > 100 x 109/l hemoglobin > 9,5 g/dl - Hepatic function as follows : Bilirubin < 1,25 LNS ASAT / ALAT <5 x NAlcPh <5 x N
- PS < 3
- cerebral metastasis eligible if asymptomatic
- Histologically or cytologically confirmed NSCLC
- Stage IV/IIIB4 (T4 with pleural effusion)
- No prior chemotherapy
- relapses of previous NSCLC treated by surgery or radiotherapy are eligible, if the target is measurable out of initial radiotherapy field and if cytological or histological proof
- At least one measurable target lesion by RECIST guidelines
Who cannot join
- symptomatic cerebral metastasis
- Any severe comorbidity calculated by Charlson score according to table 1
- ADL > 0 and IADL > 1- performance status >2 (ECOG)
- peripheral neuropathy grade 2 or more
- dementia, repeated falls, urinary or faecal incontinence
- contra-indication to corticosteroids
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- contra indication to a product of this study
- unwilling or unable to comply with study requirements, for personal, family, sociologic, geographic or any other reason
- inability of the subject to give written informed consent
- lack of liberty following legal or administrative decision
- hypersensitivity to polysorbate
- hypersensitivity to erlotinib or any excipients of this product
- unusual hereditary disorders, as galactosemia, deficit in lactase and syndrome of malabsorption in glucose or galactose
- participation in concomitant clinical trial
- bronchioloalveolar or neuroendocrine or composite carcinoma
- superior vena cava syndrome
Trial locations and contacts
23 sites in 1 country.
23 sites in 1 country
France23 sites
Site 12
Aix-en-Provence, 13100
Site 05
Bastia, 20200
Site 22
Beauvais, 60021
Site 43
Caen, 14000
Site 30
Charleville-Mézières, 08000
Site 33
Créteil, 94010
Site 07
Draguignan, 83300
Site 32
Elbeuf, 76503
Site 04
Gap, 05000
Site 41
Le Chesnay, 78157
Site 00
Limoges
Site 25
Mantes-la-Jolie, 78200
Site 06
Marseille, 13274
Site 27
Martigues, 13695
Site 01
Meaux, 77108
Site 42
Orléans, 45032
Site 26
Paris, 75012
Site 19
Périgueux, 24019
Site 02
Reims, 51092
Site 20
Rennes, 35033
Site 17
Rouen, 76233
Site 14
Toulon, 83800
Site 11
Villefranche-sur-Saône, 69655
About this study
Official title: A Multicenter Randomized Phase II Trial in NSCLC Stage IV et IIIB in Elderly Dependent Patients With Evaluation of the Sequence Gemcitabine First Line Followed by Erlotinib When Progression Versus Erlotinib First Line Followed by Gemcitabine When Progression.
The purpose of this study is in non small-cell lung cancer stage IV et IIIB (T4 with pleural effusion) in elderly dependent patients with evaluation of the sequence Gemcitabine first line followed by Erlotinib when progression versus Erlotinib first line followed by Gemcitabine when progression
Read the detailed description
A multicenter phase II trial,prospective,randomized,open,non comparative
- Conditions
- Non Small Cell Lung Cancer
- Being tested
- TARCEVA, Gemzar
- Keywords
- cancer, Lung cancer, None small-cell lung cancer
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Neoplasms, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TARCEVADrug
Also called Erlotinib
Tarceva (150 mg) is a pill you take once a day -- every day -- to help treat non-small cell lung cancer.
GemzarDrug
Also called Gemcitabine
GEMZAR by mixing it into a solution and giving it through a needle into a vein-called intravenous infusion (IV). This will take about 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2007 (estimated)
- Study startJul 2006
- Primary completionSep 2006
- Study completionMar 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non Small Cell Lung CancerStudies of the same condition, open and under way.
- 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
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Groupe Francais De Pneumo-Cancerologie
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hervé LECAER, Doctor, Principal investigator, Groupe Francais De Pneumo-Cancerologie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00419042
- Sponsor's protocol ID
- GFPC 05-05
- Status last verified
- Mar 2010
- First submitted
- 4 Jan 2007
- Last updated
- 1 Oct 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Randomized Phase II Trial in NSCLC Stage IV et IIIB in Elderly Dependent Patients With Evaluation of the Sequence Gemcitabine First Line Followed by Erlotinib When Progression Versus Erlotinib First Line Followed by Gemcitabine When Progression.
- ClinicalTrials.gov ID
- NCT00419042
- Acronym / sponsor ID
- GFPC 05-05
- Conditions
- Non Small Cell Lung Cancer
- Keywords
- cancer, Lung cancer, None small-cell lung cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Groupe Francais De Pneumo-CancerologieUniversity, hospital or other
- Study start
- Jul 2006
- Primary completion
- Sep 2006 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 5 Jan 2007 (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 purpose of this study is in non small-cell lung cancer stage IV et IIIB (T4 with pleural effusion) in elderly dependent patients with evaluation of the sequence Gemcitabine first line followed by Erlotinib when progression versus Erlotinib first line followed by Gemcitabine when progression
Detailed description
A multicenter phase II trial,prospective,randomized,open,non comparative
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Patients with non small-cell lung cancer stage IV et IIIB (T4 with pleural effusion) in elderly dependent patients
Key inclusion criteria (15 listed)
- Age > 65
- Comorbidities score, PS and frailty score according to table 1
- No dementia, faecal or urinary incontinence, repeated falls
- ADL = 0, IADL = 0-1
- Life expectancy at least 12 weeks
Key exclusion criteria (16 listed)
- symptomatic cerebral metastasis
- Any severe comorbidity calculated by Charlson score according to table 1
- ADL > 0 and IADL > 1- performance status >2 (ECOG)
- peripheral neuropathy grade 2 or more
- dementia, repeated falls, urinary or faecal incontinence
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TARCEVAAlso: ErlotinibTarceva (150 mg) is a pill you take once a day -- every day -- to help treat non-small cell lung cancer. | Drug | – |
| GemzarAlso: GemcitabineGEMZAR by mixing it into a solution and giving it through a needle into a vein-called intravenous infusion (IV). This will take about 30 minutes | Drug | – |
Primary outcome
Not reported in the source record.
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 1 Oct 2013.
- Groupement Francais de Pneumo-cancérologieLink provided by the sponsor.
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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.
Hervé LECAER, Doctor principal investigator
Groupe Francais De Pneumo-Cancerologie
23 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 Small Cell Lung Cancer, run by Groupe Francais De Pneumo-Cancerologie at 23 sites in France.
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 15 inclusion and 16 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 1 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites in France. 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.
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 1 Oct 2013.