Reduction of Postoperative Radiotherapy in Head and Neck Squamous Cell Carcinoma

Trial Title: Reduction of Postoperative Radiotherapy in Head and Neck Squamous Cell Carcinoma

NCT ID: NCT06630780

Condition: Head and Neck Squamous Cell Carcinoma (HNSCC)

Conditions: Official terms:
Carcinoma
Carcinoma, Squamous Cell
Squamous Cell Carcinoma of Head and Neck

Conditions: Keywords:
HNSCC
Post-radical surgery
Adjuvant Radiotherapy
Radiation dose reduction
Quality of life

Study type: Interventional

Study phase: N/A

Overall status: Not yet recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Intervention model description: Phase II trial

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Radiation
Intervention name: Head and Neck Cancers
Description: 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.
Arm group label: Trial Group

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.

Detailed description: In order to understand whether it can better protect normal tissues such as pharyngeal constriction muscles, thyroid, parotid glands, and submandibular glands without affecting the efficacy of tumors, and reduce the negative impact of radiotherapy on immunotherapy, the investigators plan to conduct a prospective phase II study to explore the control rate and quality of life of patients with late head and neck squamous cell carcinoma who have obtained postoperative pCR after cervical lymph node surgery with neoadjuvant chemotherapy combined with immunotherapy.

Criteria for eligibility:
Criteria:
Inclusion Criteria: - Preoperative pathologically confirmed initial treatment of head and neck squamous cell carcinoma - Receive neoadjuvant chemotherapy combined with PD-1 monoclonal antibody immunotherapy, and meet one of the following conditions: Preoperative clinical stage was T3-T4 or N2-N3 (AJCC 8th edition). Patients with oral cancer/oropharyngeal cancer had positive lymph nodes in the IV/V region with imaging diagnosis or biopsy confirmation before surgery. HPV/ P16-positive oropharyngeal cancer patients with clinical lymph node invasion (ENE), one positive cervical lymph node > 3cm or multiple positive cervical lymph nodes before surgery - The pathology of at least one cervical lymph node was determined by pCR； - Karnofsky's physical status score ≥70 points； - Age: 18 ~ 70 years old； - Laboratory examination results within 1 week before enrollment met the following conditions: neutrophils (ANC) ≥1.5×109/L, platelets (PLT) ≥ 75×109/L - Patients participate voluntarily and sign informed consent forms. Exclusion Criteria: - Previous head and neck radiation treatment - Severe complications； - Pregnant or lactating women - Who were deemed unsuitable for inclusion by the researchers.

Gender: All

Minimum age: 18 Years

Maximum age: 70 Years

Healthy volunteers: No

Start date: October 20, 2024

Completion date: December 31, 2029

Lead sponsor:
Agency: Sun Yat-sen University
Agency class: Other

Source: Sun Yat-sen University

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06630780