Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
120 participants
OBSERVATIONAL
2016-04-30
2018-07-31
Brief Summary
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Detailed Description
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◦◦Source data is compared to external data sources medical records, either paper or electronic case report forms.
* NCI CTCAE v5.0 for AE records
* Patient recruitment according to inclusion criteria: 1. Newly diagnosed locally head and neck squamous cell carcinoma; 2. Apply for primary chemoradiation or adjuvant chemoradiation; 3. Signed informed consent
* Sample size assessment: 60 subjects will be included in one year for total 120 subjects
* Missing data to address situations where variables are reported as missing, unavailable, "non-reported," uninterpretable, or considered missing because of data inconsistency or out-of-range results
* Fisher's exact test is for category comparison. Kaplan-Meier analysis is for survival analysis. AE grades will be analyzed according to NCI guideline. Two-side p \< 0.05 is suggested significant.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* Newly diagnosed head and neck squamous cell carcinoma
* Tissue proved
* Signed informed consent
* Suitable for chemoradiation
Exclusion Criteria
* Allergy to chemotherapy
* Uncontrolled skin diseases or mucosa diseases
* Previously radiation therapy over head and neck
* Combined with other cancer currently
21 Years
70 Years
ALL
No
Sponsors
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Taipei Veterans General Hospital, Taiwan
OTHER_GOV
Responsible Party
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Principal Investigators
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Ling-Wei Wang, MD
Role: PRINCIPAL_INVESTIGATOR
Cancer Center, Taipei Veterans General Hospital
Locations
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Cancer Center, Taipei Veterans General Hospital
Taipei, , Taiwan
Countries
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Central Contacts
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Other Identifiers
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2016-03-008AC
Identifier Type: -
Identifier Source: org_study_id
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