Non-Small Cell Lung CancerPhase 3NCT00430651
Docetaxel and Carboplatin Versus Docetaxel as Second Line Treatment in Patients With Non-Small-Cell Lung Carcinoma (NSCLC)
A Phase 3 study testing Docetaxel and Carboplatin in people with Non-Small Cell Lung Cancer, run by Hellenic Oncology Research Group at 10 sites in Greece.
Trial summary
This trial will compare the effectiveness of Docetaxel with or without Carboplatin as second line chemotherapy in patients with Non-Small Cell Lung Cancer, who have not been treated previously with Docetaxel. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Non-Small Cell Lung Cancer
- What is being tested?
- Docetaxel and Carboplatin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 135 participants
- Where
- 10 sitesGreece
- Study dates
- Jul 2004to May 2008
- Phase
- Phase 3
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically or cytologically confirmed NSCLC.
- ECOG Performance Status 0-2.
- No previous treatment with Docetaxel.
- Measurable Disease.
- Brain metastases that have been treated with radiotherapy should be stable and asymptomatic.
- Adequate liver kidney and bone marrow function.
- Patients must be able to understand the nature of this study and give written informed consent.
Who cannot join
- Active cardiac disease: unstable angina or onset of angina within last 3 months, myocardial infarction within 6 months, congestive heart failure > class II, cardiac ventricular arrhythmias requiring anti-arrhythmic therapy.
- Women who are pregnant or lactating.
- Unknown HIV, chronic hepatitis B or chronic hepatitis C infections.
- Serious neurologic or psychiatric disease.
- Second primary malignancy within the past 5 years, except nonmelanomas skin cancer or in situ carcinoma of the cervix.
- Active uncontrolled infection.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
Greece10 sites
University General Hospital of Alexandroupolis, Dep of Medical Oncology
Alexandroupoli
"IASO" General Hospital of Athnes, Dep of Medical Oncology
Athens
"Laikon" General Hospital, Medical Oncology Unit, Propedeutic Dep of Internal Medicine
Athens
"Sotiria" General Hospital, 1st, 3rd, 6th, 7th, 8th Dep of Pulmonary Diseases
Athens
401 Military Hospital, Medical Oncology Unit
Athens
Air Forces Military Hospital, Dep of Medical Oncology
Athens
Sismanogleio General Hospital, 1st, 2nd Dep of Pulmonary Diseases
Athens
University Hospital of Crete
Heraklion, Crete, 71110
"Metaxa's" Anticancer Hospital of Pireaus
Piraeus
"Theagenion" Anticancer Hospital of Thessaloniki
Thessaloniki
About this study
Official title: Multicenter Randomized Phase III Study Comparing Docetaxel With Carboplatin Versus Docetaxel Single Agent as Second Line Treatment in Patients With Non-Small Cell Lung Cancer (NSCLC).
This trial will compare the effectiveness of Docetaxel with or without Carboplatin as second line chemotherapy in patients with Non-Small Cell Lung Cancer, who have not been treated previously with Docetaxel.
- Conditions
- Non-Small Cell Lung Cancer
- Being tested
- Docetaxel, Carboplatin
- Keywords
- Non Small Cell Lung Cancer, 2nd line chemotherapy, Docetaxel
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DocetaxelDrug
Also called Taxotere
Docetaxel 50 mg/m2 IV on days 1 and 15 every 28 days for 6 cycles
CarboplatinDrug
Docetaxel 50 mg/m2 IV over 1 hour followed by Carboplatin 4 AUC IV over 1 hour on days 1 and 15
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Docetaxel + Carboplatin Receives: Drug: Docetaxel; Drug: Carboplatin |
| 2 | Experimental | Docetaxel Receives: Drug: Docetaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of the overall survival between the two treatment groups
Measured: 1 year
Secondary outcomes (3)
Comparison of the objective response rates between the two treatment groups
Measured: Objective responses confirmed by CT or MRI (on 3rd and 6th cycle)
Evaluation and comparison of the toxicity between the two treatment groups
Measured: Toxicity assessment on each chemotherapy cycle
Measurement and comparison of the health-related quality of life of patients on both treatment groups
Measured: Assessment every two cycles
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2007 (estimated)
- Study startJul 2004
- Primary completionMay 2008
- Study completionMay 2008
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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 135 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hellenic Oncology Research Group
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital of Crete
- Investigators
- Vassilis Georgoulias, MD, Principal investigator, University Hospital of Crete, Dep of Medical Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00430651
- Sponsor's protocol ID
- CT/04.14
- Status last verified
- Jan 2009
- First submitted
- 1 Feb 2007
- Last updated
- 28 Jan 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Randomized Phase III Study Comparing Docetaxel With Carboplatin Versus Docetaxel Single Agent as Second Line Treatment in Patients With Non-Small Cell Lung Cancer (NSCLC).
- ClinicalTrials.gov ID
- NCT00430651
- Acronym / sponsor ID
- CT/04.14
- Conditions
- Non-Small Cell Lung Cancer
- Keywords
- Non Small Cell Lung Cancer, 2nd line chemotherapy, Docetaxel
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 135 participants (actual)
- Lead sponsor
- Hellenic Oncology Research GroupUniversity, hospital or other
- Collaborators
- University Hospital of Crete
- Study start
- Jul 2004
- Primary completion
- May 2008 (actual)
- Study completion
- May 2008 (actual)
- First posted
- 2 Feb 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.
This trial will compare the effectiveness of Docetaxel with or without Carboplatin as second line chemotherapy in patients with Non-Small Cell Lung Cancer, who have not been treated previously with Docetaxel.
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, Drug: CarboplatinDocetaxel + Carboplatin |
| 2 | Experimental | Drug: DocetaxelDocetaxel |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Histologically or cytologically confirmed NSCLC.
- ECOG Performance Status 0-2.
- No previous treatment with Docetaxel.
- Measurable Disease.
- Brain metastases that have been treated with radiotherapy should be stable and asymptomatic.
Key exclusion criteria (6 listed)
- Active cardiac disease: unstable angina or onset of angina within last 3 months, myocardial infarction within 6 months, congestive heart failure > class II, cardiac ventricular arrhythmias requiring anti-arrhythmic therapy.
- Women who are pregnant or lactating.
- Unknown HIV, chronic hepatitis B or chronic hepatitis C infections.
- Serious neurologic or psychiatric disease.
- Second primary malignancy within the past 5 years, except nonmelanomas skin cancer or in situ carcinoma of the cervix.
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 |
|---|---|---|
| DocetaxelAlso: TaxotereDocetaxel 50 mg/m2 IV on days 1 and 15 every 28 days for 6 cycles | Drug | 1, 2 |
| CarboplatinDocetaxel 50 mg/m2 IV over 1 hour followed by Carboplatin 4 AUC IV over 1 hour on days 1 and 15 | Drug | 1 |
Primary outcome
Comparison of the overall survival between the two treatment groups
Time frame: 1 year
3 secondary outcomes
Comparison of the objective response rates between the two treatment groups
Time frame: Objective responses confirmed by CT or MRI (on 3rd and 6th cycle)
Evaluation and comparison of the toxicity between the two treatment groups
Time frame: Toxicity assessment on each chemotherapy cycle
Measurement and comparison of the health-related quality of life of patients on both treatment groups
Time frame: Assessment every two cycles
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 28 Jan 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.
Vassilis Georgoulias, MD principal investigator
University Hospital of Crete, Dep of Medical Oncology
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Docetaxel and Carboplatin in people with Non-Small Cell Lung Cancer, run by Hellenic Oncology Research Group at 10 sites in Greece.
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 7 inclusion and 6 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 28 Jan 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Greece. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Comparison of the overall survival between the two treatment groups (time frame: 1 year). 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 28 Jan 2009.