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Brief Title: The Efficacy and Safety of De-escalated Postoperative Radiotherapy in Locally Advanced HNSCC With pCR/MPR
Official Title: De-escalation of Postoperative Radiotherapy in Locally Advanced Head and Neck Squamous Cell Carcinoma With Pathological Complete Response/Major Pathological Response: A Single-arm, Prospective Phase II Clinical Study
Study ID: NCT05854823
Brief Summary: 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.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Fifth Affiliated Hospital of Sun Yat-sen University, Zhuhai, Guangdong, China