ThymomaPhase 2NCT00818090
Paclitaxel and Cisplatin for Thymic Neoplasm
A Phase 2 study testing paclitaxel and cisplatin in people with Thymoma and Thymic Carcinoma, run by Korean Cancer Study Group at 1 site in South Korea.
Trial summary
To assess the efficacy and safety of the regimen in previously untreated, unresectable invasive thymoma or thymic carcinoma Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thymoma, Thymic Carcinoma
- What is being tested?
- paclitaxel and cisplatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteSouth Korea
- Study dates
- Sep 2008to Nov 2011
- 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 or cytologically confirmed invasive thymoma or thymic carcinoma
- unresectable tumor: by either local invasion, distant metastasis, or recurred (assessed by investigator)
- no previous systemic treatment for invasive thymoma or thymic carcinoma
- at least one measurable lesion by RECIST criteria
- 18 years old or older
- ECOG performance status 0, 1, 2
- adequate lab. findings neutrophil ≥ 1.5 x 10^9/L platelet ≥ 75 x 10^9/L hemoglobin ≥ 9.0 g/dL bilirubin ≤ 1.5 x upper normal limit AST, ALT ≤ 2.5 x upper normal limit Alkaline phosphatase ≤ 2.5 x upper normal limit (if liver metastasis, ≤ 5 x upper normal limit) serum creatinine ≤ 1.0 x upper normal limit if serum creatinine > 1.0 x upper normal limit, creatinine clearance ≥ 60 mL/min
- patient who agree to written, informed consent
Who cannot join
- other malignancy (exception: non-melanoma skin cancer, cervical carcinoma in situ, cancer without evidence more than 5 years since curative resection)
- active bacterial infection
- history of clinical trial with investigational drug within 30 days
- radiotherapy to thoracic or mediastinal area (other area radiotherapy is permitted)
- pregnant, or lactating women
- patient with organ transplantation
Show all 9Show fewer
- peripheral neuropathy, grade 2 or greater
- severe, medical condition unstable cardiac disease despite of adequate management myocardial infarction within 6 months active ulcer disease refractory to medication chronic obstructive lung disease requiring admission treatment within 1 year
- uncontrolled seizure, cerebral nervous system disorder, psychiatric problem which decrease treatment compliance
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase II Study of Paclitaxel and Cisplatin in Previously Untreated, Unresectable Invasive Thymoma or Thymic Carcinoma
To assess the efficacy and safety of the regimen in previously untreated, unresectable invasive thymoma or thymic carcinoma
- Conditions
- Thymoma, Thymic Carcinoma
- Being tested
- paclitaxel and cisplatin
- Keywords
- thymic epithelial tumor, paclitaxel, cisplatin, thymic carcinoma, invasive thymoma
- Medical subject headings
- Thymoma, Thymic epithelial tumor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
paclitaxel and cisplatinDrug
paclitaxel and cisplatin every 3 weeks
| Study group | Role | What they receive |
|---|---|---|
| TP | Experimental | paclitaxel and cisplatin every 3 weeks Receives: Drug: paclitaxel and cisplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response rate
Measured: 6 weeks, 12 weeks, 18 weeks
Secondary outcomes (4)
toxicity
Measured: start of medication to 4 weeks since the last medication
progression-free survival
Measured: till progression
duration of response
Measured: till progression
overall survival
Measured: till death, last follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2009 (estimated)
- Study startSep 2008
- Primary completionNov 2011
- Study completionNov 2011
Why it stopped: marginal statistical significance
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ThymomaStudies 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Korean Cancer Study Group
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Se-Hoon Lee, Korean Cancer Study Group
- Investigators
- Dae Seog Heo, MD, PhD, Principal investigator, Seoul National University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00818090
- Sponsor's protocol ID
- KCSG-LU08-03; CRCST-L-0003
- Status last verified
- Sep 2012
- First submitted
- 5 Jan 2009
- Last updated
- 12 Apr 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Paclitaxel and Cisplatin in Previously Untreated, Unresectable Invasive Thymoma or Thymic Carcinoma
- ClinicalTrials.gov ID
- NCT00818090
- Acronym / sponsor ID
- KCSG-LU08-03; CRCST-L-0003
- Conditions
- Thymoma, Thymic Carcinoma
- Keywords
- thymic epithelial tumor, paclitaxel, cisplatin, thymic carcinoma, invasive thymoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: marginal statistical significance
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Korean Cancer Study GroupUniversity, hospital or other
- Study start
- Sep 2008
- Primary completion
- Nov 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 7 Jan 2009 (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 efficacy and safety of the regimen in previously untreated, unresectable invasive thymoma or thymic carcinoma
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TP | Experimental | Drug: paclitaxel and cisplatinpaclitaxel and cisplatin every 3 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- histologically or cytologically confirmed invasive thymoma or thymic carcinoma
- unresectable tumor: by either local invasion, distant metastasis, or recurred (assessed by investigator)
- no previous systemic treatment for invasive thymoma or thymic carcinoma
- at least one measurable lesion by RECIST criteria
- 18 years old or older
Key exclusion criteria (9 listed)
- other malignancy (exception: non-melanoma skin cancer, cervical carcinoma in situ, cancer without evidence more than 5 years since curative resection)
- active bacterial infection
- history of clinical trial with investigational drug within 30 days
- radiotherapy to thoracic or mediastinal area (other area radiotherapy is permitted)
- pregnant, or lactating women
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 |
|---|---|---|
| paclitaxel and cisplatinpaclitaxel and cisplatin every 3 weeks | Drug | TP |
Primary outcome
Response rate
Time frame: 6 weeks, 12 weeks, 18 weeks
4 secondary outcomes
toxicity
Time frame: start of medication to 4 weeks since the last medication
progression-free survival
Time frame: till progression
duration of response
Time frame: till progression
overall survival
Time frame: till death, last follow-up
Results and safety
The study was stopped early (reason given: marginal statistical significance). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2013.
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STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
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A Pilot Study to Investigate the Safety and Clinical Activity of Avelumab (MSB0010718C) in Thymoma and Thymic Carcinoma After Progression on Platinum-Based Chemotherapy
Thymoma, Thymic Carcinoma
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A Study of Safety and Efficacy of KFA115 Alone and in Combo With Pembrolizumab in Patients With Select Advanced Cancers
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RecruitingPhase 2
PT-112 in Subjects With Thymoma and Thymic Carcinoma
Thymic Epithelial Tumor, Recurrent Thymoma
Not yet recruitingPhase 2
Phase II Trial of Hypofractionated Radiotherapy Guided by Optical Surface Imaging and Fan-beam CT for Thymoma With Pleural Metastasis
Thymoma and Thymic Carcinoma, Pleural Metastasis
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.
Dae Seog Heo, MD, PhD principal investigator
Seoul National 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 paclitaxel and cisplatin in people with Thymoma and Thymic Carcinoma, run by Korean Cancer Study Group 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 8 inclusion and 9 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: stopped early, as of the sponsor's last update on 12 Apr 2013. 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 was stopped early (reason given: marginal statistical significance). Results are not available in the source record.
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?
Response rate (time frame: 6 weeks, 12 weeks, 18 weeks). 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 12 Apr 2013.