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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00818090
Other study ID # KCSG-LU08-03; CRCST-L-0003
Secondary ID
Status Terminated
Phase Phase 2
First received January 5, 2009
Last updated April 11, 2013
Start date September 2008
Est. completion date November 2011

Study information

Verified date September 2012
Source Korean Cancer Study Group
Contact n/a
Is FDA regulated No
Health authority Korea: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

To assess the efficacy and safety of the regimen in previously untreated, unresectable invasive thymoma or thymic carcinoma


Recruitment information / eligibility

Status Terminated
Enrollment 39
Est. completion date November 2011
Est. primary completion date November 2011
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- 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

Exclusion Criteria:

- 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

- 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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
paclitaxel and cisplatin
paclitaxel and cisplatin every 3 weeks

Locations

Country Name City State
Korea, Republic of Seoul National University Hospital Seoul

Sponsors (1)

Lead Sponsor Collaborator
Korean Cancer Study Group

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary Response rate 6 weeks, 12 weeks, 18 weeks No
Secondary toxicity start of medication to 4 weeks since the last medication Yes
Secondary progression-free survival till progression No
Secondary duration of response till progression No
Secondary overall survival till death, last follow-up No
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