Lung NeoplasmsPhase 2NCT00258739
Docetaxel in Non Small Cell Lung Cancer (NSCLC)
A Phase 2 study testing Docetaxel + carboplatin + radiotherapy + docetaxel + gemcitabine and Docetaxel + gemcitabine + carboplatin + radiotherapy in people with Lung Neoplasms, run by Sanofi at 1 site in Spain.
Trial summary
Primary objective: To classify the 2 study groups, according to the tumoral response. Secondary objectives: To evaluate the percentage of focused control per year. To calculate the time until progression. To evaluate the safety profile. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Neoplasms
- What is being tested?
- Docetaxel + carboplatin + radiotherapy + docetaxel + gemcitabine and Docetaxel + gemcitabine + carboplatin + radiotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteSpain
- Study dates
- Oct 2001to Sep 2007
- Phase
- Phase 2
- 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
Who may be able to join
- Non small cell lung cancer confirmed by histology or by cytology.
- IIIB stage, except if existing pleural discharge, upper cava vein syndrome or supraclavicular affectation
- General stage 0-1 at the ECOG scale
- Loss of weight less than 5% in the 3 previous months from diagnose.
- Pulmonary function and gasometry results: FEV1 > 30% or 1 l, DLCO (diffusing capacity of the lung for carbon monoxide) > 30%, PCO2 < 45 mmHg and PO2 > 60 mmHg.
- Normal medullar function (hemoglobin > 11 g/dl, total WBC > 1,5 x 10^9/l, platelets > 100 x 10^9/l)
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- Appropriate renal and hepatic functions
- CTScan
- Anticonceptive method
- Available laboratory test (maximum 1 month before)
Who cannot join
- Pleural discharge, upper cava vein syndrome or supraclavicular affectation.
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase II, Randomized Study With Docetaxel-gemcitabine Followed by Radiotherapy vs Concomitant Treatment (Radiotherapy and Carboplatine-docetaxel) Followed by Docetaxel-gemcitabine Versus Docetaxel-gemcitabine Followed by Concomitant Treatment (Radiotherapy and Carboplatine-docetaxel) in Stage III NSCLC
Primary objective:
- To classify the 2 study groups, according to the tumoral response.
Secondary objectives:
- To evaluate the percentage of focused control per year.
- To calculate the time until progression.
- To evaluate the safety profile.
- Conditions
- Lung Neoplasms
- Being tested
- Docetaxel + carboplatin + radiotherapy + docetaxel + gemcitabine, Docetaxel + gemcitabine + carboplatin + radiotherapy
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Docetaxel + carboplatin + radiotherapy + docetaxel + gemcitabineDrug
Docetaxel 20 mg/m²/week with carboplatin AUC 2/week and concomitant radiotherapy up to 60 Gy. Further on, 2 Docetaxel cycles and gemcitabine according to arm 2.
Docetaxel + gemcitabine + carboplatin + radiotherapyOther
Docetaxel 40 mg/ m² days 1, 8, 21 and 28 with gemcitabine 1200 mg/ m² days 1, 8, 21 and 28 followed by concomitant treatment with docetaxel 20 mg/m²/week with carboplatin AUC 2/week and concomitant radiotherapy up to 60 Gy (2 Gy/day, 5 days per week and for 6 weeks).
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Concomitant radiotherapy and carboplatin-docetaxel followed by docetaxel-gemcitabine Receives: Drug: Docetaxel + carboplatin + radiotherapy + docetaxel + gemcitabine |
| 2 | Experimental | docetaxel-gemcitabine followed by concomitant radiotherapy with carboplatin-docetaxel Receives: Other: Docetaxel + gemcitabine + carboplatin + radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response rate in each arm measured according to RECIST criteria
Measured: Throughout the whole study
Secondary outcomes (4)
Percentage of local-regional control within a year
Measured: Throughout the first year
Time to progression defined as the period of time elapsed between the randomization date and the progression or death date
Measured: Throughout the whole study
Toxicity measured by CALGB criteria and RTOG/EORTC criteria
Measured: Throughout the whole study
Global surveillance measured as the period of time elapsed between randomization and death date.
Measured: Throughout the whole study duration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2005 (estimated)
- Study startOct 2001
- Primary completionSep 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung NeoplasmsStudies of the same condition, open and under way.
- More trials run by SanofiThe 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- José Mª Taboada, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00258739
- Sponsor's protocol ID
- TAX_ES1_209
- Status last verified
- Dec 2009
- First submitted
- 23 Nov 2005
- Last updated
- 7 Dec 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Randomized Study With Docetaxel-gemcitabine Followed by Radiotherapy vs Concomitant Treatment (Radiotherapy and Carboplatine-docetaxel) Followed by Docetaxel-gemcitabine Versus Docetaxel-gemcitabine Followed by Concomitant Treatment (Radiotherapy and Carboplatine-docetaxel) in Stage III NSCLC
- ClinicalTrials.gov ID
- NCT00258739
- Acronym / sponsor ID
- TAX_ES1_209
- Conditions
- Lung Neoplasms
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Oct 2001
- Primary completion
- Sep 2007 (actual)
- First posted
- 28 Nov 2005 (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.
Primary objective:
- To classify the 2 study groups, according to the tumoral response.
Secondary objectives:
- To evaluate the percentage of focused control per year.
- To calculate the time until progression.
- To evaluate the safety profile.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Docetaxel + carboplatin + radiotherapy + docetaxel + gemcitabineConcomitant radiotherapy and carboplatin-docetaxel followed by docetaxel-gemcitabine |
| 2 | Experimental | Other: Docetaxel + gemcitabine + carboplatin + radiotherapydocetaxel-gemcitabine followed by concomitant radiotherapy with carboplatin-docetaxel |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Non small cell lung cancer confirmed by histology or by cytology.
- IIIB stage, except if existing pleural discharge, upper cava vein syndrome or supraclavicular affectation
- General stage 0-1 at the ECOG scale
- Loss of weight less than 5% in the 3 previous months from diagnose.
- Pulmonary function and gasometry results: FEV1 > 30% or 1 l, DLCO (diffusing capacity of the lung for carbon monoxide) > 30%, PCO2 < 45 mmHg and PO2 > 60 mmHg.
Key exclusion criteria (2 listed)
- Pleural discharge, upper cava vein syndrome or supraclavicular affectation.
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
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 |
|---|---|---|
| Docetaxel + carboplatin + radiotherapy + docetaxel + gemcitabineDocetaxel 20 mg/m²/week with carboplatin AUC 2/week and concomitant radiotherapy up to 60 Gy. Further on, 2 Docetaxel cycles and gemcitabine according to arm 2. | Drug | 1 |
| Docetaxel + gemcitabine + carboplatin + radiotherapyDocetaxel 40 mg/ m² days 1, 8, 21 and 28 with gemcitabine 1200 mg/ m² days 1, 8, 21 and 28 followed by concomitant treatment with docetaxel 20 mg/m²/week with carboplatin AUC 2/week and concomitant radiotherapy up to 60 Gy (2 Gy/day, 5 days per week and for 6 weeks). | Other | 2 |
Primary outcome
Response rate in each arm measured according to RECIST criteria
Time frame: Throughout the whole study
4 secondary outcomes
Percentage of local-regional control within a year
Time frame: Throughout the first year
Time to progression defined as the period of time elapsed between the randomization date and the progression or death date
Time frame: Throughout the whole study
Toxicity measured by CALGB criteria and RTOG/EORTC criteria
Time frame: Throughout the whole study
Global surveillance measured as the period of time elapsed between randomization and death date.
Time frame: Throughout the whole study duration
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 7 Dec 2009.
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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.
José Mª Taboada study director
Sanofi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Docetaxel + carboplatin + radiotherapy + docetaxel + gemcitabine and Docetaxel + gemcitabine + carboplatin + radiotherapy in people with Lung Neoplasms, run by Sanofi at 1 site 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 10 inclusion and 2 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 7 Dec 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Response rate in each arm measured according to RECIST criteria (time frame: Throughout the whole study). 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 7 Dec 2009.