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RECRUITING
NCT05854823
NA

The Efficacy and Safety of De-escalated Postoperative Radiotherapy in Locally Advanced HNSCC With pCR/MPR

Sponsor: Fifth Affiliated Hospital, Sun Yat-Sen University

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

23

Start Date

2023-04-10

Completion Date

2027-04-09

Last Updated

2023-05-11

Healthy Volunteers

No

Interventions

RADIATION

dose-reduced radiotherapy

Patients receive 50Gy/25F, 2Gy/F QD, five days a week for 5 weeks

Locations (1)

Fifth Affiliated Hospital of Sun Yat-sen University

Zhuhai, Guangdong, China