ALDH2 Mutation in Taiwanese Head and Neck Cancer

• Conditions: Dermatitis; Mucositis

• Registration Number: NCT02761408
• Lead Sponsor: Taipei Veterans General Hospital, Taiwan

Brief Summary

The purpose of this study is to evaluate the effect of ALDH2 mutation in radiation associating dermatitis or mucositis in head and neck cancer patients who accept chemoradiation therapy

Detailed Description

* One-site audit. The enrolled subject is confirmed by PIs

◦◦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.

Study Timeline

• Status Verified: 2016-04
• Study Start: 2016-04
• Study First Submitted: 2016-04-26
• Study First Submitted QC: 2016-05-02
• Last Update Submitted: 2016-05-02
• Study First Posted: 2016-05-04
• Last Update Posted: 2016-05-04
• Primary Completion: 2018-04
• Study Completion: 2018-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• Age >20, <70
• Newly diagnosed head and neck squamous cell carcinoma
• Tissue proved
• Signed informed consent
• Suitable for chemoradiation

Exclusion Criteria

• Uncontrolled underlying diseases
• Allergy to chemotherapy
• Uncontrolled skin diseases or mucosa diseases
• Previously radiation therapy over head and neck
• Combined with other cancer currently

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of participants with treatment-related adverse events assessed by CTCAEv5.0	6 months after the end of the study	The side effects of each participant will be recorded accoiding to CTCAEv5.0 during the whole course of chemoradiation, by indicated physicians regularly

Trial Locations

Locations (1)

Cancer Center, Taipei Veterans General Hospital; 🇨🇳 Taipei, Taiwan