Thymic Carcinoma, Thymoma
Conditions
Keywords
thymic epithelial tumor, paclitaxel, cisplatin, thymic carcinoma, invasive thymoma
Brief summary
To assess the efficacy and safety of the regimen in previously untreated, unresectable invasive thymoma or thymic carcinoma
Interventions
paclitaxel and cisplatin every 3 weeks
Sponsors
Korean Cancer Study Group
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response rate | 6 weeks, 12 weeks, 18 weeks |
Secondary
| Measure | Time frame |
|---|---|
| toxicity | start of medication to 4 weeks since the last medication |
| progression-free survival | till progression |
| duration of response | till progression |
| overall survival | till death, last follow-up |
Countries
South Korea
Outcome results
None listed