Clincal Study of Reduced Target Radiotherapy in Nasopharyngeal Carcinoma

First Affiliated Hospital of Kunming Medical University20 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Toxicity Due to Radiotherapy Nasopharyngeal Carcinoma

Interventions

Target rangeRADIATION

Compared with conventional radiotherapy, the target dose is unchanged and the CTV2 volume is reduced.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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.

Locations (1)

First Affiliated Hospital of Kunming Medical University

Kunming, Yunnan, China

Outcomes

Primary Outcomes

incidence of acute mucosal ulcers with a toxicity grade 3 or above

incidence of acute mucosal ulcers (including those in the oral cavity and pharyngeal wall mucosa) with a toxicity grade 3 or above within 6 months after radiotherapy (that is, between the initiation of radiotherapy to 3 months postradiotherapy) among patients with no recurrence in the reduced-target area

Time frame: up to 6 months

Secondary Outcomes

locoregional recurrence-free survival

which was defined as the time from enrollment to the occurrence of locoregional recurrence, with the last tumor assessment date serving as the censoring time in the absence of locoregional recurrence

Time frame: up to 1 year

Distant metastasis-free survival

The time from date of treatment until date of death due to any cause, assessed up to 1 years.

Time frame: up to 1 years

Overall survival

The time from date of treatment until date of death due to any cause, assessed up to 1 years.

Time frame: up to 1 years

Progress Free Survival

The time from date of treatment until date of death due to any cause, assessed up to 1 years.

Time frame: up to 1 years

Acute radiation toxicity

The injuries after the beginning of radiotherapy include skin, mucosa, pharynx and esophagus, eyes, ears, nervous system, blood system and other organs and tissues，assessed up to 3 months.

Time frame: up to 3 months

Data from ClinicalTrials.gov

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