Locally Advanced Stage III or IV Thymic CancerPhase 2NCT01312324
Neoadjuvant Chemotherapy for Locally Advanced Thymic Cancer
A Phase 2 study testing neoadjuvant docetaxel/cisplatin in people with Locally Advanced Stage III or IV Thymic Cancer, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
We try to evaluate whether neoadjuvant docetaxel plus cisplatin can increase the complete resection rate in advanced thymic carcinoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Locally Advanced Stage III or IV Thymic Cancer
- What is being tested?
- neoadjuvant docetaxel/cisplatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteSouth Korea
- Study dates
- Feb 2007to Mar 2016
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- histologically confirmed thymic carcinoma
- surgically inoperable Masaoka stage III or IV
- ECOG 0-2
- at least one measurable disease
Who cannot join
- previous myocardiac infarct history within 1 year before the enrollment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective, Phase II Trial of Induction Chemotherapy With Docetaxel/Cisplatin for Masaoka Stage III/IV Thymic Epithelial Tumors
We try to evaluate whether neoadjuvant docetaxel plus cisplatin can increase the complete resection rate in advanced thymic carcinoma.
- Being tested
- neoadjuvant docetaxel/cisplatin
- Keywords
- neoadjuvant chemotherapy, thymic cancer
- Medical subject headings
- Thymus Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
neoadjuvant docetaxel/cisplatinDrug
3 cycles of docetaxel plus cisplatin docetaxel 75mg/m2 D1 cisplatin 75mg/m2 D1 every 3 weeks
| Study group | Role | What they receive |
|---|---|---|
| neoadjuvant chemotherapy | Experimental | 3 cycles of docetaxel/cisplatin before operation Receives: Drug: neoadjuvant docetaxel/cisplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete resection rate
Measured: 4-8 weeks later after completion of neoadjuvant chemotherapy
Secondary outcomes (1)
the number of patients with adverse events
Measured: from enrollment to 6 months after completion of chemotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2011 (estimated)
- Study startFeb 2007
- Primary completionJul 2015
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locally Advanced Stage III or IV Thymic CancerStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe 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
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Keunchil Park, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01312324
- Sponsor's protocol ID
- 2007-01-040
- Status last verified
- Apr 2016
- First submitted
- 6 Mar 2011
- Last updated
- 20 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Phase II Trial of Induction Chemotherapy With Docetaxel/Cisplatin for Masaoka Stage III/IV Thymic Epithelial Tumors
- ClinicalTrials.gov ID
- NCT01312324
- Acronym / sponsor ID
- 2007-01-040
- Keywords
- neoadjuvant chemotherapy, thymic cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- Feb 2007
- Primary completion
- Jul 2015 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 10 Mar 2011 (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.
We try to evaluate whether neoadjuvant docetaxel plus cisplatin can increase the complete resection rate in advanced thymic carcinoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| neoadjuvant chemotherapy | Experimental | Drug: neoadjuvant docetaxel/cisplatin3 cycles of docetaxel/cisplatin before operation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- histologically confirmed thymic carcinoma
- surgically inoperable Masaoka stage III or IV
- ECOG 0-2
- at least one measurable disease
Key exclusion criteria (1 listed)
- previous myocardiac infarct history within 1 year before the enrollment.
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 |
|---|---|---|
| neoadjuvant docetaxel/cisplatin3 cycles of docetaxel plus cisplatin docetaxel 75mg/m2 D1 cisplatin 75mg/m2 D1 every 3 weeks | Drug | neoadjuvant chemotherapy |
Primary outcome
Complete resection rate
Time frame: 4-8 weeks later after completion of neoadjuvant chemotherapy
1 secondary outcome
the number of patients with adverse events
Time frame: from enrollment to 6 months after completion 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 20 Apr 2016.
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.
The record lists no contact. Use the official record to reach the sponsor.
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 neoadjuvant docetaxel/cisplatin in people with Locally Advanced Stage III or IV Thymic Cancer, run by Samsung Medical Center at 1 site in South Korea.
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 4 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 Apr 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 South Korea. 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?
Complete resection rate (time frame: 4-8 weeks later after completion of neoadjuvant chemotherapy). 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 Apr 2016; AzTrials last refreshed its copy on 6 Nov 2026.