A Phase I Study of Concurrent Chemotherapy using TS-1 with Involved Field Radiotherapy for Elderly Patients with Non-Small Cell Lung Cancer.
Phase 1
- Conditions
- on-Small Cell Lung Cancer
- Registration Number
- JPRN-UMIN000002162
- Lead Sponsor
- Hiroshima Radiation Oncology Study Group
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- All
- Target Recruitment
- 18
Inclusion Criteria
Not provided
Exclusion Criteria
1 patient with marked fever and suspected infection 2 patient has dreaded complication 3 concomittant active malignancy 4 needing teratment pleulal effusion and hydroperitoneum syndrome 5 patient of the pericardium water retension syndrome 6 patient has chicken pox 7 Serious neuropathy 8 Anarmnesis of drug allergy 9 Severe bone marrow suppression 10 serious renal function disturbance 11 serious liver function disturbance 12 taking other fluoropyrimidime 13 Under treatment with flucytosine 14 Not suitable for participating in the study for any othe reason
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To determine maximum tolerated dose and recommended dose of TS-1+RT for elderly patients of Non-small cell lung cancer.
- Secondary Outcome Measures
Name Time Method Adverse events for treatment (56days) or after 56days, Response rate (RR), Overall survival (OS), Disease control rate, Disease free survival (DFS)