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.
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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
50
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.
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
RECRUITING2-year region-free recurrence survival (RRFS)
Time to confirmed diagnosis of documented recurrence of cervical lymph nodes or death from any cause
Time frame: 2-year
Progression-free survival (PFS)
Defined as documented treatment progression or death from any cause.
Time frame: 2-year
Distant metastasis-free survival (DMFS)
Defined as documented distant metastases or death from any cause
Time frame: 2-year
Overall survival (OS)
Defined as a documented death due to any cause or last follow-up; regional recurrence pattern; and acute and late toxicity.
Time frame: 2-year
Local recurrence-free survival (LRFS)
Defined as documented primary tumor recurrence or death from any cause
Time frame: 2-year
Acute and Late Radiation Injuries
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.
Time frame: Day 1 of radiotherapy to 2 years post-treatment
Quality of life assessment
The Quality of Life (QoL) was assessed at baseline and during follow-up using the European Organization for the Head and Neck Cancer Module (QLQ-H\&N35) version 1.0.
Time frame: 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.
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Quality of life assessment
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).
Time frame: 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.