Reduction of Postoperative Radiotherapy in Head and Neck Squamous Cell Carcinoma

Not Applicable

Recruiting

• Conditions: Head and Neck Squamous Cell Carcinoma (HNSCC)

• Registration Number: NCT06630780
• Lead Sponsor: Sun Yat-sen University

Brief 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.

Study Timeline

• Study First Submitted: 2024-09-17
• Status Verified: 2024-10
• Study First Submitted QC: 2024-10-07
• Study First Posted: 2024-10-08
• Study Start: 2024-10-20
• Last Update Submitted: 2025-01-04
• Last Update Posted: 2025-01-07
• Primary Completion: 2029-12-31
• Study Completion: 2029-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
2-year region-free recurrence survival (RRFS)	2-year	Time to confirmed diagnosis of documented recurrence of cervical lymph nodes or death from any cause

Secondary Outcome Measures

Name	Time	Method
Progression-free survival (PFS)	2-year	Defined as documented treatment progression or death from any cause.
Distant metastasis-free survival (DMFS)	2-year	Defined as documented distant metastases or death from any cause
Overall survival (OS)	2-year	Defined as a documented death due to any cause or last follow-up; regional recurrence pattern; and acute and late toxicity.
Quality of life assessment	Baseline, during radiotherapy, at the end of radiotherapy, 3 months after the end of radiotherapy, 6 months after the end of radiotherapy, and thereafter according to routine follow-up until 2 years.	The Quality of Life (QoL) was assessed at baseline and during follow-up using the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30).
Local recurrence-free survival (LRFS)	2-year	Defined as documented primary tumor recurrence or death from any cause
Acute and Late Radiation Injuries	Day 1 of radiotherapy to 2 years post-treatment	The acute radiation toxicity was assessed using the CTCAE 5.0 version, while the RTOG and EORTC late radiation toxicity scales were used to evaluate late toxicity.

Trial Locations

Locations (1)

Sun Yat-sen University Cancer Center; 🇨🇳 Guangzhou, Guangdong, China