JPRN-jRCTs042180119
Completed
Phase 2
A feasibility study of intensity modulated radiotherapy with chemotherapy for locally advanced non-small-cell lung cancer
Harada Hideyuki0 sites22 target enrollmentMarch 19, 2019
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Clinical stage 3 non-small-cell lung cancer
- Sponsor
- Harada Hideyuki
- Enrollment
- 22
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
The primary endpoint for tolerability of chemoradiotherapy with intensity-modulated radiotherapy could not be achieved. However, intensity-modulated radiotherapy could be completed in all but one case, demonstrating good survival and safety.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\)Non\-small cell lung cancer(NSCLC) diagnosed by cytological or histological examination
- •2\)Inoperable
- •3\)Clinical stage 3 NSCLC, possible for definitive radiotherapy
- •4\)No previous chemotherapy or radiotherapy
- •5\)Measurable lesions
- •6\)Age; 20 \-75 years old
- •7\)ECOG performance status:0\-1
- •8\)Ingestible
- •9\)Sufficient function in bone marrow, heart, lung, liver and kidney
- •10\)Written informed consent
Exclusion Criteria
- •1\)Active double cancer
- •2\)Severe infection or morbidity
- •3\)HBs antigen positive
- •4\)Previous thoracic radiotherapy
- •5\)Interstitial pneumonia or fibrosis on CT
- •6\)Severe emphysema or chronic bronchitis or asthma
- •7\)Severe drug allergy
- •8\)Severe diabetes
- •9\)Unstable angina or myocardial infarction within 6 months
- •10\)Febrile more than or equal to 38 degree
Outcomes
Primary Outcomes
Not specified
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