Carcinoma, Non-Small-Cell LungPhase 3NCT00622349
Randomised Study Comparing Three Chemotherapy Regimens in Non-small Cell Lung Cancer
A Phase 3 study testing Cisplatin, Ifosfamide, Gemcitabine, Ifosfamide, Gemcitabine and Cisplatin, docetaxel in people with Carcinoma, Non-Small-Cell Lung, run by European Lung Cancer Working Party at 4 sites in 4 countries.
Trial summary
The purpose of this study is to determine if cisplatin-based chemotherapy, cisplatin-gemcitabine-ifosfamide or cisplatin-docetaxel, will improve survival in comparison to the combination gemcitabine-ifosfamide in patients with advanced NSCLC Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoma, Non-Small-Cell Lung
- What is being tested?
- Cisplatin, Ifosfamide, Gemcitabine, Ifosfamide, Gemcitabine and Cisplatin, docetaxel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 707 participants
- Where
- 4 sitesin 4 countries
- Study dates
- Feb 2004to Dec 2009
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histological or cytological diagnosis of non-small cell lung cancer
- Advanced (unresectable or functionally inoperable) stage III or stage IV disease
- Availability for participating in the detailed follow-up of the protocol
- Presence of an evaluable or measurable lesion
- Informed consent
Who cannot join
- Prior treatment with chemotherapy
- Operable patient with resectable tumour
- Performance status < 60 on the Karnofsky scale
- A history of prior malignant tumour, except non-melanoma skin cancer or in situ carcinoma of the cervix and cured malignant tumour (more than 5-year disease free interval)
- Polynuclear cells < 2,000/mm³
- Platelet cells < 100,000/mm³
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- Serum bilirubin >1.5 mg/100 ml
- Serum creatinine > 1.5 mg/100 ml and/or creatinine clearance < 60 ml/min
- Perception hypoacousia
- Peripheral neuropathy
- Recent myocardial infarction (less than 3 months prior to date of diagnosis)
- Congestive cardiac failure requiring medical therapy or uncontrolled cardiac arrhythmia
- Uncontrolled infectious disease
- Serious medical or psychological factors which may prevent adherence to the treatment schedule
Trial locations and contacts
4 sites in 4 countries.
4 sites in 4 countries
Belgium1 site
Department of Intensive Care Unit and Thoracic Oncology Institut Jules Bordet
Brussels, 1000
About this study
Official title: A Phase III Randomised Study Comparing Three Combination Chemotherapy Regimens in Patients With Non Pre-treated Advanced Non-small Cell Lung Cancer
The purpose of this study is to determine if cisplatin-based chemotherapy, cisplatin-gemcitabine-ifosfamide or cisplatin-docetaxel, will improve survival in comparison to the combination gemcitabine-ifosfamide in patients with advanced NSCLC
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Being tested
- Cisplatin, Ifosfamide, Gemcitabine, Ifosfamide, Gemcitabine, Cisplatin, docetaxel
- Keywords
- Randomised phase III, Chemotherapy, Advanced non-small cell lung carcinoma
- 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.
Cisplatin, Ifosfamide, GemcitabineDrug
Cisplatin 50 mg/m² day 1 Ifosfamide 3g/m² day 1 (+ uromitexan rescue) Gemcitabine 1 g/m² days 1 and 8 Cycles every 3 weeks
Ifosfamide, GemcitabineDrug
Ifosfamide 3g/m² day 1 (+ uromitexan rescue) Gemcitabine 1 g/m² days 1 and 8 Cycles every 3 weeks
Cisplatin, docetaxelDrug
Cisplatin 50 mg/m² day 1 Docetaxel 75 mg/m² day 1 Cycles every 3 weeks
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Not described Receives: Drug: Cisplatin, Ifosfamide, Gemcitabine |
| B | Active comparator | Not described Receives: Drug: Ifosfamide, Gemcitabine |
| C | Experimental | Not described Receives: Drug: Cisplatin, docetaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival
Measured: Survival will be dated from the first day of registration until death or last follow up
Secondary outcomes (3)
Response rate
Measured: Every 3 courses of chemotherapy
Toxicity
Measured: After each course of chemotherapy
Activity of second-line chemotherapy
Measured: Every 3 courses of chemotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2008 (estimated)
- Study startFeb 2004
- Primary completionMar 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinoma, Non-Small-Cell LungStudies 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
- 707 participants (actual)
Sponsor and investigators
- Lead sponsor
- European Lung Cancer Working Party
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-Paul Sculier, MD, PhD, Study chair, European Lung Cancer Working Party
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00622349
- Sponsor's protocol ID
- ELCWP-01041
- Status last verified
- Jan 2013
- First submitted
- 14 Feb 2008
- Last updated
- 30 Jan 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III Randomised Study Comparing Three Combination Chemotherapy Regimens in Patients With Non Pre-treated Advanced Non-small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT00622349
- Acronym / sponsor ID
- ELCWP-01041
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Keywords
- Randomised phase III, Chemotherapy, Advanced non-small cell lung carcinoma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 707 participants (actual)
- Lead sponsor
- European Lung Cancer Working PartyUniversity, hospital or other
- Study start
- Feb 2004
- Primary completion
- Mar 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 25 Feb 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 purpose of this study is to determine if cisplatin-based chemotherapy, cisplatin-gemcitabine-ifosfamide or cisplatin-docetaxel, will improve survival in comparison to the combination gemcitabine-ifosfamide in patients with advanced NSCLC
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: Cisplatin, Ifosfamide, Gemcitabine |
| B | Active comparator | Drug: Ifosfamide, Gemcitabine |
| C | Experimental | Drug: Cisplatin, docetaxel |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Histological or cytological diagnosis of non-small cell lung cancer
- Advanced (unresectable or functionally inoperable) stage III or stage IV disease
- Availability for participating in the detailed follow-up of the protocol
- Presence of an evaluable or measurable lesion
- Informed consent
Key exclusion criteria (14 listed)
- Prior treatment with chemotherapy
- Operable patient with resectable tumour
- Performance status < 60 on the Karnofsky scale
- A history of prior malignant tumour, except non-melanoma skin cancer or in situ carcinoma of the cervix and cured malignant tumour (more than 5-year disease free interval)
- Polynuclear cells < 2,000/mm³
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 |
|---|---|---|
| Cisplatin, Ifosfamide, GemcitabineCisplatin 50 mg/m² day 1 Ifosfamide 3g/m² day 1 (+ uromitexan rescue) Gemcitabine 1 g/m² days 1 and 8 Cycles every 3 weeks | Drug | A |
| Ifosfamide, GemcitabineIfosfamide 3g/m² day 1 (+ uromitexan rescue) Gemcitabine 1 g/m² days 1 and 8 Cycles every 3 weeks | Drug | B |
| Cisplatin, docetaxelCisplatin 50 mg/m² day 1 Docetaxel 75 mg/m² day 1 Cycles every 3 weeks | Drug | C |
Primary outcome
Survival
Time frame: Survival will be dated from the first day of registration until death or last follow up
3 secondary outcomes
Response rate
Time frame: Every 3 courses of chemotherapy
Toxicity
Time frame: After each course of chemotherapy
Activity of second-line chemotherapy
Time frame: Every 3 courses of chemotherapy
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 30 Jan 2013.
- Click here for more information on the protocolLink provided by the sponsor.
- Trial registry of the French National Cancer InstituteLink 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.
Jean-Paul Sculier, MD, PhD study chair
European Lung Cancer Working Party
4 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Cisplatin, Ifosfamide, Gemcitabine, Ifosfamide, Gemcitabine and Cisplatin, docetaxel in people with Carcinoma, Non-Small-Cell Lung, run by European Lung Cancer Working Party at 4 sites in 4 countries.
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 5 inclusion and 14 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 30 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Belgium, France, Greece, 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 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?
Survival (time frame: Survival will be dated from the first day of registration until death or last follow up). 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 30 Jan 2013.