Lung CancerPhase 3NCT00144053
A Phase Ⅲ Randomized Study of Mitomycin/Vindesine/Cisplatin Versus Irinotecan/Carboplatin Versus Paclitaxel/Carboplatin With Concurrent Thoracic Radiotherapy for Unresectable Stage Ⅲ Non-Small-Cell Lung Cancer
A Phase 3 study testing Cisplatin+Vindesine+MMC/ concurrent radiation, Irinotecan+Carboplatin/concurrent radiation and Paclitaxel+Carboplatin/concurrent radiation in people with Lung Cancer, run by West Japan Thoracic Oncology Group.
Trial summary
To evaluate whether two weekly concurrent chemoradiotherapy regimens offer any advantage over concurrent chemoradiotherapy regimens with Cisplatin, Vindesine, Mitomycin for unresectable stage III NSCLC. Read more about this study
- Who is it for?
- Ages 20 to 74 years
- Conditions the study is for
- Lung Cancer
- What is being tested?
- Cisplatin+Vindesine+MMC/ concurrent radiation, Irinotecan+Carboplatin/concurrent radiation and Paclitaxel+Carboplatin/concurrent radiation
- How many people
- 450 participants
- Where
- No sites listed yet
- Study dates
- Apr 2001to not given
- 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 20 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients had histologically or cytologically confirmed locally advanced NSCLC. All patients must not have undergone any previous therapy for NSCLC. Patients had to have measurable disease, an Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1, and to be less than 75 years old. Adequate organ (bone marrow, renal, liver, heart, and lung) function was required. All patients gave written informed consent.
Who cannot join
- The exclusion criteria consisted of pulmonary fibrosis, pleural effusion, pregnancy, lactation, active concurrent malignancies, severe drug allergies, myocardial infarction, severe heart disease, uncontrollable diabetes mellitus, and infection. -
About this study
To evaluate whether two weekly concurrent chemoradiotherapy regimens offer any advantage over concurrent chemoradiotherapy regimens with Cisplatin, Vindesine, Mitomycin for unresectable stage III NSCLC.
- Conditions
- Lung Cancer
- Being tested
- Cisplatin+Vindesine+MMC/ concurrent radiation, Irinotecan+Carboplatin/concurrent radiation, Paclitaxel+Carboplatin/concurrent radiation
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cisplatin+Vindesine+MMC/ concurrent radiationDrug
Irinotecan+Carboplatin/concurrent radiationDrug
Paclitaxel+Carboplatin/concurrent radiationDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival
Secondary outcomes (1)
safety
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2005 (estimated)
- Study startApr 2001
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- 450 participants
Sponsor and investigators
- Lead sponsor
- West Japan Thoracic Oncology Group
- Sponsor type
- University, hospital or other
- Investigators
- Hisao Uejima, MD, Principal investigator, West Japan Thoracic Oncology Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00144053
- Sponsor's protocol ID
- WJTOG0105
- Status last verified
- Aug 2005
- First submitted
- 31 Aug 2005
- Last updated
- 6 Jan 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ⅲ Randomized Study of Mitomycin/Vindesine/Cisplatin Versus Irinotecan/Carboplatin Versus Paclitaxel/Carboplatin With Concurrent Thoracic Radiotherapy for Unresectable Stage Ⅲ Non-Small-Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT00144053
- Acronym / sponsor ID
- WJTOG0105
- Conditions
- Lung Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 450 participants
- Lead sponsor
- West Japan Thoracic Oncology GroupUniversity, hospital or other
- Study start
- Apr 2001
- First posted
- 2 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.
To evaluate whether two weekly concurrent chemoradiotherapy regimens offer any advantage over concurrent chemoradiotherapy regimens with Cisplatin, Vindesine, Mitomycin for unresectable stage III NSCLC.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 20 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patients had histologically or cytologically confirmed locally advanced NSCLC. All patients must not have undergone any previous therapy for NSCLC. Patients had to have measurable disease, an Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1, and to be less than 75 years old. Adequate organ (bone marrow, renal, liver, heart, and lung) function was required. All patients gave written informed consent.
Key exclusion criteria (1 listed)
- The exclusion criteria consisted of pulmonary fibrosis, pleural effusion, pregnancy, lactation, active concurrent malignancies, severe drug allergies, myocardial infarction, severe heart disease, uncontrollable diabetes mellitus, and infection. -
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+Vindesine+MMC/ concurrent radiation | Drug | – |
| Irinotecan+Carboplatin/concurrent radiation | Drug | – |
| Paclitaxel+Carboplatin/concurrent radiation | Drug | – |
Primary outcome
Survival
1 secondary outcome
safety
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 6 Jan 2006.
- Related InfoLink 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.
Hisao Uejima, MD principal investigator
West Japan Thoracic Oncology Group
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Cisplatin+Vindesine+MMC/ concurrent radiation, Irinotecan+Carboplatin/concurrent radiation and Paclitaxel+Carboplatin/concurrent radiation in people with Lung Cancer, run by West Japan Thoracic Oncology Group.
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 1 inclusion and 1 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 6 Jan 2006. Status can change between updates, so confirm with the study contact before making plans.
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. 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 6 Jan 2006.