Clincal Study of Reduced Target Radiotherapy in Nasopharyngeal Carcinoma

Nasopharyngeal Carcinoma Clinical Trial

Official title:

Clincal Study of Reduced Target Radiotherapy Based on The Law and Distribution Characteristics of Cervical Lymph Nodes Metastasis in Nasopharyngeal Carcinoma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05741008
• Other study ID #: 2021BS005
• Status: Recruiting
• Phase: N/A
• Start date: January 31, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: February 2023
• Source: First Affiliated Hospital of Kunming Medical University
• Contact: Zhiqiang Wang, MD
• Phone: 15887085161
• Email: wangzhiqiang[@]ydyy.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 25
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma
• Nasopharyngeal Carcinoma
• Toxicity Due to Radiotherapy

Intervention

Radiation:
• Target range
Compared with conventional radiotherapy, the target dose is unchanged and the CTV2 volume is reduced.

Locations

Country	Name	City	State
China	First Affiliated Hospital of Kunming Medical University	Kunming	Yunnan

Sponsors (1)

Lead Sponsor	Collaborator
First Affiliated Hospital of Kunming Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Regional recurrence-free survival	The time from date of treatment until date of first documented disease recurrence at a regional site, assessed up to 1 years.	up to 1 years
Secondary	Overall survival	The time from date of treatment until date of death due to any cause, assessed up to 1 years.	up to 1 years
Secondary	Distant metastasis-free survival	The time from date of treatment until date of death due to any cause, assessed up to 1 years.	up to 1 years
Secondary	Progress Free Survival	The time from date of treatment until date of death due to any cause, assessed up to 1 years.	up to 1 years
Secondary	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.	up to 3 months