Reduction of Postoperative Radiotherapy in Head and Neck Squamous Cell Carcinoma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Head and Neck Cancers.
- Who it may be relevant to
- Registry conditions: Head and Neck Squamous Cell Carcinoma (HNSCC). Basic parameters: 18 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Prospective Phase II Clinical Trial on the Reduction of Postoperative Radiotherapy in Head and Neck Squamous Cell Carcinoma
Overview
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
- Radiation 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.
Primary outcome measures
- 2-year region-free recurrence survival (RRFS) [Time frame: 2-year]
Secondary outcome measures (7)
- Progression-free survival (PFS) [Time frame: 2-year]
- Distant metastasis-free survival (DMFS) [Time frame: 2-year]
- Overall survival (OS) [Time frame: 2-year]
- Local recurrence-free survival (LRFS) [Time frame: 2-year]
- Acute and Late Radiation Injuries [Time frame: Day 1 of radiotherapy to 2 years post-treatment]
- Quality of life assessment [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.]
- Quality of life assessment [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.]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Sun Yat-sen University Cancer Center — Guangzhou
Identifiers
NCT: NCT06630780 · 2023-FXY-224