KCT0003330
Recruiting
未知
Phase II trial of paclitaxel (T) vs Irinotecan(I) in patients with previously Etoposide/platinum (EP) treated, extensive disease (ED) small cell lung cancer (SCLC) as 2nd line chemotherapy
Chung-Ang Univerisity Hospital0 sites136 target enrollmentTBD
ConditionsNeoplasms
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Neoplasms
- Sponsor
- Chung-Ang Univerisity Hospital
- Enrollment
- 136
- Status
- Recruiting
- Last Updated
- 7 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\) Histologically or cytologically diagnosed dilated stage small cell lung cancer patient
- •2\) Patients who were treated with etoposide / platinum combination therapy as a first\-line treatment and who had more than partial response (PR) and sustained more than 90 days. However, it is a rule to keep it for more than 90 days, but it is also possible to register patients who are kept for more than 60 days.
- •3\) In the presence of brain metastases with neurological symptoms, previous radiation therapy or surgical treatment for brain metastases was neurologically stable (no progressive neurological symptoms, and steroid therapy was discontinued). Radiation therapy The researcher has determined that the toxicity of
- •4\) When radiation therapy is applied to areas other than the brain, it can be selected when the scope of irradiation does not include target lesions
- •5\) Appropriate bone marrow, liver, new function
- •Serum creatinine ? Normal upper limit of each organ (UNL)
- •Serum transaminase \= UNL x 2\.0 (if there is liver damage ? UNL x 5
- •Serum bilirubin ? UNL x 1\.5
- •neutrophil count ? 1,500 / uL, platelets ? 100,000 / uL
- •6\) If there is more than one measurable lesion based on RECIST criteria
Exclusion Criteria
- •1\) Patients with brain metastases whose symptoms are not adequately controlled
- •2\) Patients with significant infectious disease to which parenteral antibiotics should be administered
- •3\) diarrhea patients whose symptoms are not adequately controlled
- •4\) Chronic inflammatory bowel disease whose symptoms are not adequately controlled
- •5\) Patients with bowel obstruction, bowel obstruction
- •6\) Patients with interstitial pneumonia or pulmonary fibrosis
- •7\) Patients with dialysis
- •8\) Pregnant or potentially pregnant women and lactating women
- •9\) Patients receiving Atazanavir Sulfate
- •10\) Patients who have a history of hypersensitivity reactions to xylitol or its components. Patients with a history of severe hypersensitivity to other drugs containing Cremophor® EL (polyoxyethylated castor oil)
Outcomes
Primary Outcomes
Not specified
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