NSCLCPhase 2NCT00172380
Phase II Study of Docetaxel Plus CDDP for NSCLC Stage III
A Phase 2 study testing Docetaxel Plus CDDP in people with NSCLC, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
To assess the overall response rate to docetaxel plus CDDP as neoadjuvant chemotherapy prior to surgery, followed by adjuvant docetaxel plus CDDP in chemonaive patients NSCLC Stage IIIa and IIIb. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- NSCLC
- What is being tested?
- Docetaxel Plus CDDP
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteTaiwan
- Study dates
- Feb 2005to Mar 2010
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically or cytologically confirmed NSCLC, respectable NSCLC stage IIIa T1-2 N2 or or unresectable stage IIIb 2.KPS>70% 3.Hb>10g/dl,ANC>2.0x109/L,Plt.>100x109/L4.T-bil.<1xULN,creatinine<1xULN,creatinine clearance >60 ml/min,GPT/GOT<2.5xULN,ALP<5xULN
Who cannot join
- 1.Brain meta.2..Prior surgery,R/T, C/t or immunotherapy for NSCLC
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Department of Internal Medicine, National Taiwan University Hospital
Taipei, 100
About this study
Official title: Phase II Study Evaluating Docetaxel and CDDP as Neoadjuvant Chemotherapy Prior to Surgery, Followed by Adjuvant Docetaxel Plus CDDP in Chemonaive Patients With NSCLC Stage III
To assess the overall response rate to docetaxel plus CDDP as neoadjuvant chemotherapy prior to surgery, followed by adjuvant docetaxel plus CDDP in chemonaive patients NSCLC Stage IIIa and IIIb.
- Conditions
- NSCLC
- Being tested
- Docetaxel Plus CDDP
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Docetaxel Plus CDDPDrug
docetaxel 36mg/m2 and cisplatin 75mg/m2
| Study group | Role | What they receive |
|---|---|---|
| docetaxel and cisplatin | Experimental | docetaxel 36mg/m2 and cisplatin 75mg/m2 Receives: Drug: Docetaxel Plus CDDP |
What is being measured
The primary outcome is the main question the study is designed to answer.
overall response rate
Measured: every cycle during 2nd-6th cycles
Secondary outcomes (3)
resectability
Measured: resectability after treatment
progression free survival
Measured: progression free survival after 1 year
overall survival
Measured: overall survival at 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2005 (estimated)
- Study startFeb 2005
- Primary completionJan 2010
- Study completionMar 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NSCLCStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chong-Jen Yu, M.D,Ph.D., Principal investigator, Department of Internal Medicine, National Taiwan University hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00172380
- Sponsor's protocol ID
- 930911
- Status last verified
- Dec 2012
- First submitted
- 12 Sep 2005
- Last updated
- 20 Dec 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study Evaluating Docetaxel and CDDP as Neoadjuvant Chemotherapy Prior to Surgery, Followed by Adjuvant Docetaxel Plus CDDP in Chemonaive Patients With NSCLC Stage III
- ClinicalTrials.gov ID
- NCT00172380
- Acronym / sponsor ID
- 930911
- Conditions
- NSCLC
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Feb 2005
- Primary completion
- Jan 2010 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 15 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 assess the overall response rate to docetaxel plus CDDP as neoadjuvant chemotherapy prior to surgery, followed by adjuvant docetaxel plus CDDP in chemonaive patients NSCLC Stage IIIa and IIIb.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| docetaxel and cisplatin | Experimental | Drug: Docetaxel Plus CDDPdocetaxel 36mg/m2 and cisplatin 75mg/m2 |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Histologically or cytologically confirmed NSCLC, respectable NSCLC stage IIIa T1-2 N2 or or unresectable stage IIIb 2.KPS>70% 3.Hb>10g/dl,ANC>2.0x109/L,Plt.>100x109/L4.T-bil.<1xULN,creatinine<1xULN,creatinine clearance >60 ml/min,GPT/GOT<2.5xULN,ALP<5xULN
Key exclusion criteria (1 listed)
- 1.Brain meta.2..Prior surgery,R/T, C/t or immunotherapy for NSCLC
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 |
|---|---|---|
| Docetaxel Plus CDDPdocetaxel 36mg/m2 and cisplatin 75mg/m2 | Drug | docetaxel and cisplatin |
Primary outcome
overall response rate
Time frame: every cycle during 2nd-6th cycles
3 secondary outcomes
resectability
Time frame: resectability after treatment
progression free survival
Time frame: progression free survival after 1 year
overall survival
Time frame: overall survival at 1 year
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 20 Dec 2012.
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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.
Chong-Jen Yu, M.D,Ph.D. principal investigator
Department of Internal Medicine, National Taiwan University hospital
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 Docetaxel Plus CDDP in people with NSCLC, run by National Taiwan University Hospital at 1 site in Taiwan.
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 20 Dec 2012. 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 Taiwan. 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?
overall response rate (time frame: every cycle during 2nd-6th cycles). 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 20 Dec 2012.