Non-Small-Cell Lung CarcinomaPhase 3NCT00148395
Randomized Phase III-Study in Stage IIIb and IV Non-Small-Cell Lung Cancer. Sequential Single-Agent vs. Double-Agent vs. Triple-Agent Therapy.
A Phase 3 study testing Gemcitabine, Navelbine and Carboplatin in people with Non-Small-Cell Lung Carcinoma, run by Aktion Bronchialkarzinom e.V. at 1 site in Germany.
Trial summary
This study wants to assess different intensive therapy sequences for the treatment of non-small-cell lung cancer. It claims less on the efficacy of different chemotherapy combinations, than more on the comparison of different strategies of sequential single-agent, sequential double-agent or sequential triple-agent… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Non-Small-Cell Lung Carcinoma
- What is being tested?
- Gemcitabine, Navelbine and Carboplatin
- How many people
- 280 participants
- Where
- 1 siteGermany
- Study dates
- Jun 2002to Apr 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
- Histological verified non-small cell lung cancer. Cytological diagnosis is accepted for doubtless results.
- Present stage IIIb with malignant pleural effusion or stage IV disease. Tumor dissemination should not be irradiable in one field
- Age between 18 and 75 years
- Karnofsky index 70 - 100%
- Measurable or evaluable tumor parameter
- No prior chemotherapy for NSCLC
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- Sufficient hematological parameter before start of therapy (leucocytes > 3.500/µl and platelets > 100.000/µl).
- Sufficient liver function (bilirubin < 1,6mg/dl)
- Sufficient renal function (creatinine < 1,5mg/dl and clearance > 60ml/min)
- Minimal estimated life expectancy > 3 months
- Written informed consent for study attendance
- Patient accessibility for therapy and follow up
- No attendance to an other study
Who cannot join
- Small-cell lung cancer oder tumors with small-cell fractions
- Local advanced irradiable stage III
- Previous chemotherapy because of other diseases, not longer than 3 years ago
- Simultaneous radiation of all present tumor manifestations
- Simultaneous or not longer than 3 years ago secondary malignancy, except carcinoma in situ of the cervix or dermal cancer, others than melanoma
- Respiratory insufficiency
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- Heart insufficiency NYHA III and IV
- Peripheral arteriosclerosis stage III and IV
- Neurological and psychiatric diseases, which affect understanding of the study concept and the possibility to keep conditions of the protocol
- Pregnancy, breastfeeding or not ensured contraception
- HIV-infection
- Active hepatitis B and C
- Manifest infectious diseases before start of therapy
- Minimal estimated life expectancy < 3 months
- No written informed consent of the patient for study attendance and storage and disclosure of disease data according to the protocol
Trial locations and contacts
1 site in 1 country.
About this study
This study wants to assess different intensive therapy sequences for the treatment of non-small-cell lung cancer.
It claims less on the efficacy of different chemotherapy combinations, than more on the comparison of different strategies of sequential single-agent, sequential double-agent or sequential triple-agent therapy.
- Conditions
- Non-Small-Cell Lung Carcinoma
- Being tested
- Gemcitabine, Navelbine, Carboplatin, Cisplatin, Mitomycin
- 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.
GemcitabineDrug
NavelbineDrug
CarboplatinDrug
CisplatinDrug
MitomycinDrug
IfosfamideDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
Secondary outcomes (2)
Event-free survival
Quality of live
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2005 (estimated)
- Study startJun 2002
- Study completionApr 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 CarcinomaStudies 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
- 280 participants
Sponsor and investigators
- Lead sponsor
- Aktion Bronchialkarzinom e.V.
- Sponsor type
- University, hospital or other
- Investigators
- Martin Wolf, MD, Study chair, Klinikum Kassel GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00148395
- Sponsor's protocol ID
- NSCLC 06/2001
- Status last verified
- Apr 2008
- First submitted
- 7 Sep 2005
- Last updated
- 22 Apr 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Phase III-Study in Stage IIIb and IV Non-Small-Cell Lung Cancer. Sequential Single-Agent vs. Double-Agent vs. Triple-Agent Therapy.
- ClinicalTrials.gov ID
- NCT00148395
- Acronym / sponsor ID
- NSCLC 06/2001
- Conditions
- Non-Small-Cell Lung Carcinoma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 280 participants
- Lead sponsor
- Aktion Bronchialkarzinom e.V.University, hospital or other
- Study start
- Jun 2002
- Study completion
- Apr 2008 (actual)
- First posted
- 8 Sep 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.
This study wants to assess different intensive therapy sequences for the treatment of non-small-cell lung cancer.
It claims less on the efficacy of different chemotherapy combinations, than more on the comparison of different strategies of sequential single-agent, sequential double-agent or sequential triple-agent therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Histological verified non-small cell lung cancer. Cytological diagnosis is accepted for doubtless results.
- Present stage IIIb with malignant pleural effusion or stage IV disease. Tumor dissemination should not be irradiable in one field
- Age between 18 and 75 years
- Karnofsky index 70 - 100%
- Measurable or evaluable tumor parameter
Key exclusion criteria (15 listed)
- Small-cell lung cancer oder tumors with small-cell fractions
- Local advanced irradiable stage III
- Previous chemotherapy because of other diseases, not longer than 3 years ago
- Simultaneous radiation of all present tumor manifestations
- Simultaneous or not longer than 3 years ago secondary malignancy, except carcinoma in situ of the cervix or dermal cancer, others than melanoma
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 |
|---|---|---|
| Gemcitabine | Drug | – |
| Navelbine | Drug | – |
| Carboplatin | Drug | – |
| Cisplatin | Drug | – |
| Mitomycin | Drug | – |
| Ifosfamide | Drug | – |
Primary outcome
Overall survival
2 secondary outcomes
Event-free survival
Quality of live
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 22 Apr 2008.
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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.
Martin Wolf, MD study chair
Klinikum Kassel GmbH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Gemcitabine, Navelbine and Carboplatin in people with Non-Small-Cell Lung Carcinoma, run by Aktion Bronchialkarzinom e.V. at 1 site 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 13 inclusion and 15 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 22 Apr 2008. 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 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.
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?
Overall survival. 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 22 Apr 2008.