Идёт набор NCT06630780

Reduction of Postoperative Radiotherapy in Head and Neck Squamous Cell Carcinoma

Без фазы С лечением Head and Neck Squamous Cell Carcinoma (HNSCC)

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: Head and Neck Cancers.
Кому может быть актуально: Состояния в реестре: Head and Neck Squamous Cell Carcinoma (HNSCC). Базовые параметры: 18 лет — 70 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Китай
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

A Prospective Phase II Clinical Trial on the Reduction of Postoperative Radiotherapy in Head and Neck Squamous Cell Carcinoma

Обзор

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.

Подробное описание

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.

Вмешательства

Лучевая терапия 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.

Первичные конечные точки

2-year region-free recurrence survival (RRFS) [Срок оценки: 2-year]

Вторичные конечные точки (7)

Progression-free survival (PFS) [Срок оценки: 2-year]
Distant metastasis-free survival (DMFS) [Срок оценки: 2-year]
Overall survival (OS) [Срок оценки: 2-year]
Local recurrence-free survival (LRFS) [Срок оценки: 2-year]
Acute and Late Radiation Injuries [Срок оценки: Day 1 of radiotherapy to 2 years post-treatment]
Quality of life assessment [Срок оценки: 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 [Срок оценки: 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.]

Критерии участия

Критерии включения

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.