Reduction of Postoperative Radiotherapy in Head and Neck Squamous Cell Carcinoma

Not Applicable

Recruiting

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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Trial Group	Head 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. (1) Tumor bed (CTVtb): It was delineated based on the tumor extent shown in laryngoscopy, enhanced CT/MRI, or PET CT before induction therapy49. For patients with significant anatomical changes due to tumor regression, the CTVtb was adjusted, taking into account the patient's anatomy after induction chemotherapy and the initial state of the tumor; if a cavity appeared due to tumor regression, it was adjusted according to natural anatomical boundaries.(2) High-risk clinical target volume (CTV1): CTVtb plus a 5-10mm margin, with a prescribed dose of at least 60Gy in 30 fractions. (3) Low-risk clinical target volume (CTV2): CTV1 plus a 5-10mm margin. For hypo

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.
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.
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).

Locations (1): Sun Yat-sen University Cancer Center
🇨🇳
Guangzhou, Guangdong, China