Clincal Study of Reduced Target Radiotherapy in Nasophary... | NCT05741008

NCT05741008

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

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No data is available for this block.

Document Section

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No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Reduced target radiotherapy	Experimental	According to our institutional guidelines, GTVnx included the primary tumor volume and the enlarged retropharyngeal nodes, while GTVnd was the volume of involved gross cervical lymph nodes. The clinical tumor volume (CTV) includes the primary tumor with potential subclinical disease. The high-risk clinical target volume (CTV1) was defined as the GTVnx plus a 5-mm margin to encompass the high-risk sites of microscopic extension, the whole nasopharynx, retropharyngeal nodal regions and . The low-risk clinical target volume (CTV2) was defined as the whole neck area.(Ib, VIIb, and the commom carotid artery are not included).	Radiation: Target range

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Target range	Radiation	Compared with conventional radiotherapy, the target dose is unchanged and the CTV2 volume is reduced.	Reduced target radiotherapy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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	up to 6 months

Secondary Outcomes

Measure	Description	Time Frame
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	up to 1 year
Distant metastasis-free survival

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Histopathologically confirmed nasopharyngeal nonkeratologic carcinoma (differentiated or undifferentiated, i.e., WHO type II or Type III).
The clinical stage is TanyN2-3M0, III-IVa (AJCC 8th edition stage).
Patients who have not received radiation therapy before.
After induction chemotherapy, CR or PR were evaluated by radiography.
Age 18-65 years old.
ECOG score of 0-1.
Good organ function
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:

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.
Patients with relapsed and distant metastases.
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).
Nasopharyngeal primary tumor or retropharyngeal metastatic lymph node invasion of oropharynx.
Severe heart disease, lung dysfunction, heart function, lung function lower than grade 3 (including grade 3).
Those whose laboratory test values do not meet the relevant criteria within 7 days before enrollment.
Those who have participated in clinical trials of other drugs within 3 months before treatment.
Pregnant or lactating women.
Patients assessed by investigators to be unable to cooperate with regular follow-up due to psychological, social, family and geographical reasons.

ID	Term
D002277	Carcinoma
D009375	Neoplasms, Glandular and Epithelial
D009370	Neoplasms by Histologic Type
D009369	Neoplasms