This is an open-label, single-arm, phase II clinical trial to explore the efficacy and safety of de-escalation of postoperative radiotherapy in locally advanced head and neck squamous cell carcinoma with pathological complete response/major pathological response to neoadjuvant therapy. The eligible patients are scheduled to administered postoperative radiotherapy, PTV 50Gy/25F, instead of the standard dose of 60Gy. The overall primary study hypothesis is that reducing the dose of postoperative radiotherapy in the specific population does not affect DFS but significantly reduces treatment related adverse events.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
23
Patients receive 50Gy/25F, 2Gy/F QD, five days a week for 5 weeks
Fifth Affiliated Hospital of Sun Yat-sen University
Zhuhai, Guangdong, China
RECRUITINGDisease Free Survival (DFS)
2-year disease free survival rate
Time frame: from the first day of treatment to the follow up of 2 years
Overall Survival (OS)
2-year overall survival rate
Time frame: from the first day of treatment to the follow up of 2 years
Local Relapse Free Survival (LRFS)
2-year local relapse free survival rate
Time frame: from the first day of treatment to the follow up of 2 years
Distant Metastasis Free Survival (DMFS)
2-year distant metastasis free survival rate
Time frame: from the first day of treatment to the follow up of 2 years
EORTC QLQ-C30
Quality of life evaluation
Time frame: from 1 week before treatment to the follow up of 2 years
EORTC HN35
Quality of life evaluation
Time frame: from 1 week before treatment to the follow up of 2 years
RTOG/EORTC late radiation morbidity scoring scheme
Toxicity criteria of RTOG/EORTC
Time frame: from 1 week before treatment to the follow up of 2 years
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