Head and Neck Squamous Cell Carcinoma (HNSCC)
Conditions
Keywords
HNSCC, Post-radical surgery, Adjuvant Radiotherapy, Radiation dose reduction, Quality of life
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.
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.
Sponsors
Sun Yat-sen University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Phase II trial
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 the Head and Neck Cancer Module (QLQ-H\&N35) version 1.0. |
Countries
China
Contacts
CONTACTChun-Yan Chen
CONTACTYa-Ni Zhang
STUDY_DIRECTORLiu-Wei Tang
The Ethics Committee of the Center for Cancer Prevention and Treatment, Sun Yat-sen University
Outcome results
None listed