RecruitingNot ApplicableNCT06630780

Reduction of Postoperative Radiotherapy in Head and Neck Squamous Cell Carcinoma

A Prospective Phase II Clinical Trial on the Reduction of Postoperative Radiotherapy in Head and Neck Squamous Cell Carcinoma

Sponsor

Sun Yat-sen University

Enrollment

50 participants

Start Date

Sep 26, 2024

Study Type

INTERVENTIONAL

Conditions

Head and Neck Squamous Cell Carcinoma (HNSCC)

Summary

To explore the control rate and quality of life of participants with late head and neck squamous cell carcinoma who have obtained postoperative pCR after cervical lymph node surgery with neoadjuvant chemotherapy combined with immunotherapy, and the cervical lymph node removal prophylactic irradiation ENI in the low-risk area.

Eligibility

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study is investigating whether patients with head and neck squamous cell carcinoma (a type of throat or mouth cancer) who have had a very strong response to pre-surgery chemotherapy and immunotherapy can safely receive less radiation therapy after surgery — reducing side effects without sacrificing cancer control. **You may be eligible if...** - You have confirmed head and neck squamous cell carcinoma - You have received chemotherapy combined with a PD-1 immunotherapy drug before surgery - At least one lymph node in your neck showed a complete pathologic response (no remaining cancer cells after chemo/immunotherapy) - You are between 18 and 70 years old - Your overall health score is good **You may NOT be eligible if...** - You have had prior radiation to the head and neck area - You are pregnant or breastfeeding - You have severe health complications that the researchers feel make enrollment unsafe Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

RADIATIONHead and Neck Cancers

All patients received intensity-modulated conformal radiotherapy (IMRT). To ensure study quality, all IMRT plans were reviewed by the research team at Sun Yat-sen University Cancer Center. The delineation principles for the radiotherapy target volume of the primary tumor bed and normal tissues followed the consensus guidelines.