Pulmonary NeoplasmsPhase 2NCT00132639
Study of Preoperative Docetaxel or Cisplatin (CDDP) + Docetaxel for C-stage IB-II Non-Small Cell Lung Cancer (NSCLC)
A Phase 2 study testing Preoperative docetaxel-cisplatin combination chemotherapy and Preoperative docetaxel monotherapy in people with Pulmonary Neoplasms, run by Haruhiko Fukuda at 1 site in Japan.
Trial summary
The purpose of this study is to evaluate the safety and efficacy of the preoperative docetaxel and docetaxel-cisplatin combination in c-stage IB/II NSCLC, and select the optimal preoperative therapy for phase III trials. Read more about this study
- Who is it for?
- Ages 20 to 74 years
- Conditions the study is for
- Pulmonary Neoplasms
- What is being tested?
- Preoperative docetaxel-cisplatin combination chemotherapy and Preoperative docetaxel monotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteJapan
- Study dates
- Oct 2002to Nov 2008
- 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 20 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Newly diagnosed, pathologically documented NSCLC
- Clinical stages IB (T2N0M0), IIA (T1N1M0) or IIB (T2N1M0 or T3N0M0)
- Ages: 15-74 years old
- ECOG performance status 0 or 1
- Measurable disease
- Ample organ function
- Signed informed consent
Who cannot join
- Invasion to the first rib or more superior chest wall
- Metastasis to, or involvement of, mediastinal node
- Active concomitant malignancy
- Unstable angina, recent myocardial infarction, or heart failure
- Uncontrolled diabetes or hypertension
- Pregnant or lactating women
- Other severe complications
- Systemic use of corticosteroids
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Phase II Study of the Induction Chemotherapy With Docetaxel Alone vs CDDP + Docetaxel for C-stage IB-II Non-Small Cell Lung Cancer (JCOG 0204-MF)
The purpose of this study is to evaluate the safety and efficacy of the preoperative docetaxel and docetaxel-cisplatin combination in c-stage IB/II NSCLC, and select the optimal preoperative therapy for phase III trials.
Read the detailed description
Preoperative chemotherapy has substantial theoretical advantage. Several controlled trials are under way in early stage (clinical stage IB-II) nonsmall cell lung cancer (NSCLC). In each trial, platinum-based doublet chemotherapy is employed. Although platinum-based doublet is the treatment of choice for advanced NSCLC, risk/benefit balance might well be different in earlier stages. There have been no prospective randomized trials to choose an optimal preoperative chemotherapy in early stage NSCLC.
Comparison: Preoperative cisplatin-docetaxel combination versus docetaxel monotherapy in clinical stage IB/II NSCLC.
- Conditions
- Pulmonary Neoplasms
- Being tested
- Preoperative docetaxel-cisplatin combination chemotherapy, Preoperative docetaxel monotherapy
- Keywords
- pulmonary neoplasm, preoperative chemotherapy, cisplatin, docetaxel, randomized trial, clinical stage IB or II nonsmall cell lung cancer
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preoperative docetaxel-cisplatin combination chemotherapyDrug
Preoperative docetaxel-cisplatin combination chemotherapy
Preoperative docetaxel monotherapyDrug
Preoperative docetaxel monotherapy
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Preoperative docetaxel-cisplatin combination chemotherapy Receives: Drug: Preoperative docetaxel-cisplatin combination chemotherapy |
| 2 | Active comparator | Preoperative docetaxel monotherapy Receives: Drug: Preoperative docetaxel monotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
disease-free survival rate at 1 year
Measured: during the study conduct
Secondary outcomes (7)
overall survival
Measured: during the study conduct
disease-free survival
Measured: during the study conduct
treatment compliance
Measured: during the study conduct
response rate to chemotherapy
Measured: during the study conduct
pathologic complete response (CR) rate
Measured: during the study conduct
complete resection rate
Measured: during the study conduct
post-surgical morbidity/mortality
Measured: during the study conduct
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2005 (estimated)
- Study startOct 2002
- Primary completionNov 2008
- Study completionNov 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary NeoplasmsStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Haruhiko Fukuda
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, Labour and Welfare, Japan
- Responsible party
- Sponsor-investigator, Haruhiko Fukuda, Japan Clinical Oncology Group
- Investigators
- Harubumi Kato, MD, PhD, Study chair, Tokyo Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00132639
- Sponsor's protocol ID
- JCOG 0204-MF
- Other IDs
- C000000032
- Status last verified
- Sep 2016
- First submitted
- 19 Aug 2005
- Last updated
- 22 Sep 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Phase II Study of the Induction Chemotherapy With Docetaxel Alone vs CDDP + Docetaxel for C-stage IB-II Non-Small Cell Lung Cancer (JCOG 0204-MF)
- ClinicalTrials.gov ID
- NCT00132639
- Acronym / sponsor ID
- JCOG 0204-MF
- Conditions
- Pulmonary Neoplasms
- Keywords
- pulmonary neoplasm, preoperative chemotherapy, cisplatin, docetaxel, randomized trial, clinical stage IB or II nonsmall cell lung cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Haruhiko FukudaUniversity, hospital or other
- Collaborators
- Ministry of Health, Labour and Welfare, Japan
- Study start
- Oct 2002
- Primary completion
- Nov 2008 (actual)
- Study completion
- Nov 2008 (actual)
- First posted
- 22 Aug 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.
The purpose of this study is to evaluate the safety and efficacy of the preoperative docetaxel and docetaxel-cisplatin combination in c-stage IB/II NSCLC, and select the optimal preoperative therapy for phase III trials.
Detailed description
Preoperative chemotherapy has substantial theoretical advantage. Several controlled trials are under way in early stage (clinical stage IB-II) nonsmall cell lung cancer (NSCLC). In each trial, platinum-based doublet chemotherapy is employed. Although platinum-based doublet is the treatment of choice for advanced NSCLC, risk/benefit balance might well be different in earlier stages. There have been no prospective randomized trials to choose an optimal preoperative chemotherapy in early stage NSCLC.
Comparison: Preoperative cisplatin-docetaxel combination versus docetaxel monotherapy in clinical stage IB/II NSCLC.
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: Preoperative docetaxel-cisplatin combination chemotherapyPreoperative docetaxel-cisplatin combination chemotherapy |
| 2 | Active comparator | Drug: Preoperative docetaxel monotherapyPreoperative docetaxel monotherapy |
Who may qualify
- Ages
- 20 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Newly diagnosed, pathologically documented NSCLC
- Clinical stages IB (T2N0M0), IIA (T1N1M0) or IIB (T2N1M0 or T3N0M0)
- Ages: 15-74 years old
- ECOG performance status 0 or 1
- Measurable disease
Key exclusion criteria (8 listed)
- Invasion to the first rib or more superior chest wall
- Metastasis to, or involvement of, mediastinal node
- Active concomitant malignancy
- Unstable angina, recent myocardial infarction, or heart failure
- Uncontrolled diabetes or hypertension
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 |
|---|---|---|
| Preoperative docetaxel-cisplatin combination chemotherapyPreoperative docetaxel-cisplatin combination chemotherapy | Drug | 1 |
| Preoperative docetaxel monotherapyPreoperative docetaxel monotherapy | Drug | 2 |
Primary outcome
disease-free survival rate at 1 year
Time frame: during the study conduct
7 secondary outcomes
overall survival
Time frame: during the study conduct
disease-free survival
Time frame: during the study conduct
treatment compliance
Time frame: during the study conduct
response rate to chemotherapy
Time frame: during the study conduct
pathologic complete response (CR) rate
Time frame: during the study conduct
complete resection rate
Time frame: during the study conduct
post-surgical morbidity/mortality
Time frame: during the study conduct
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 Sep 2016.
- 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.
Harubumi Kato, MD, PhD study chair
Tokyo Medical University
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 Preoperative docetaxel-cisplatin combination chemotherapy and Preoperative docetaxel monotherapy in people with Pulmonary Neoplasms, run by Haruhiko Fukuda at 1 site in Japan.
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 8 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 Sep 2016. 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 Japan. 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?
disease-free survival rate at 1 year (time frame: during the study conduct). 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 Sep 2016; AzTrials last refreshed its copy on 7 Nov 2026.