Clinical trial NCT05741008: Clincal Study of Reduced Target Radiotherapy in Nasopharyngeal Carcinoma
Official title: Clincal Study of Reduced Target Radiotherapy Based on The Law and Distribution Characteristics of Cervical Lymph Nodes Metastasis in Nasopharyngeal Carcinoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Toxicity Due to Radiotherapy
Nasopharyngeal Carcinoma
Keywords: Reduced target
Nasopharyngeal Carcinoma
Radiotherapy
Lead sponsor: First Affiliated Hospital of Kunming Medical University
Sponsor class: OTHER
First posted: 2023-02-23
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To determine whether subtractive radiotherapy can significantly reduce the acute side effects of radiotherapy and improve the quality of life of patients on the basis of ensuring the existing curative effect.


Eligibility criteria: Inclusion Criteria:

1. Histopathologically confirmed nasopharyngeal nonkeratologic carcinoma (differentiated or undifferentiated, i.e., WHO type II or Type III).
2. The clinical stage is TanyN2-3M0, III-IVa (AJCC 8th edition stage).
3. Patients who have not received radiation therapy before.
4. After induction chemotherapy, CR or PR were evaluated by radiography.
5. Age 18-65 years old.
6. ECOG score of 0-1.
7. Good organ function
8. The patient has signed an informed letter and is willing and able to comply with the planned visits, treatment plans, laboratory tests and other research programs.

Exclusion Criteria:

1. Patients with keratinizing squamous cell carcinoma account for only about 5% of the total pathological types, and the sensitivity of radiotherapy is poor compared with the other two types heterogeneous, so nasopharyngeal carcinoma with pathology of keratinizing squamous cells (WHO type I) is excluded.
2. Patients with relapsed and distant metastases.
3. The metastatic lymph nodes are located in the target area (Ib zone, the lateral group of the retropharyngeal lymphatic drainage area (VII), and the cervical lymphatic rainage area The medial border moves from top to bottom from the medial border of the common carotid artery to the lateral border, from the annular cartilage to the superior sternal border, sternoclavicular.The triangular area between the anterior and posterior edges of the medial mastoid muscle and the anterior and lateral border of the jugular arteriovenous sheath and lateral border of the thyroid glanddomain).
4. Nasopharyngeal primary tumor or retropharyngeal metastatic lymph node invasion of oropharynx.
5. Severe heart disease, lung dysfunction, heart function, lung function lower than grade 3 (including grade 3).
6. Those whose laboratory test values do not meet the relevant criteria within 7 days before enrollment.
7. Those who have participated in clinical trials of other drugs within 3 months before treatment.
8. Pregnant or lactating women.
9. Patients assessed by investigators to be unable to cooperate with regular follow-up due to psychological, social, family and geographical reasons.

Primary outcomes:
measure: incidence of acute mucosal ulcers with a toxicity grade 3 or above
timeFrame: up to 6 months
Secondary outcomes:
measure: locoregional recurrence-free survival
timeFrame: up to 1 year
measure: Distant metastasis-free survival
timeFrame: up to 1 years
measure: Overall survival
timeFrame: up to 1 years
measure: Progress Free Survival
timeFrame: up to 1 years
measure: Acute radiation toxicity
timeFrame: up to 3 months
Other outcomes:
Locations:
city: Kunming
country: China
facility: First Affiliated Hospital of Kunming Medical University
state: Yunnan
Study officials:
References: