Clinical trial NCT06630780: Reduction of Postoperative Radiotherapy in Head and Neck Squamous Cell Carcinoma
Official title: A Prospective Phase II Clinical Trial on the Reduction of Postoperative Radiotherapy in Head and Neck Squamous Cell Carcinoma
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Head and Neck Squamous Cell Carcinoma (HNSCC)
Keywords: HNSCC
Post-radical surgery
Adjuvant Radiotherapy
Radiation dose reduction
Quality of life
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2024-10-08
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Phase II trial
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: 2-year region-free recurrence survival (RRFS)
timeFrame: 2-year
Secondary outcomes:
measure: Progression-free survival (PFS)
timeFrame: 2-year
measure: Distant metastasis-free survival (DMFS)
timeFrame: 2-year
measure: Overall survival (OS)
timeFrame: 2-year
measure: Local recurrence-free survival (LRFS)
timeFrame: 2-year
measure: Acute and Late Radiation Injuries
timeFrame: Day 1 of radiotherapy to 2 years post-treatment
measure: Quality of life assessment
timeFrame: 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.
measure: Quality of life assessment
timeFrame: 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.
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-sen University Cancer Center
state: Guangdong
Study officials:
affiliation: The Ethics Committee of the Center for Cancer Prevention and Treatment, Sun Yat-sen University
name: Liu-Wei Tang
role: STUDY_DIRECTOR
References: