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Trial Title:
Clincal Study of Reduced Target Radiotherapy in Nasopharyngeal Carcinoma
NCT ID:
NCT05741008
Condition:
Toxicity Due to Radiotherapy
Nasopharyngeal Carcinoma
Conditions: Official terms:
Carcinoma
Nasopharyngeal Carcinoma
Conditions: Keywords:
Reduced target
Nasopharyngeal Carcinoma
Radiotherapy
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Radiation
Intervention name:
Target range
Description:
Compared with conventional radiotherapy, the target dose is unchanged and the CTV2 volume
is reduced.
Arm group label:
Reduced target radiotherapy
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.
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
65 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
First Affiliated Hospital of Kunming Medical University
Address:
City:
Kunming
Zip:
650032
Country:
China
Status:
Recruiting
Contact:
Last name:
Zhiqiang Wang, MD
Phone:
15887085161
Email:
wangzhiqiang@ydyy.cn
Start date:
January 31, 2023
Completion date:
December 31, 2024
Lead sponsor:
Agency:
First Affiliated Hospital of Kunming Medical University
Agency class:
Other
Source:
First Affiliated Hospital of Kunming Medical University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05741008
