Clincal Study of Reduced Target Radiotherapy in Nasopharyngeal Carcinoma

NCT05741008 | Completed DMC

• 1 other identifier: 2021BS005
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Toxicity Due to Radiotherapy; Nasopharyngeal Carcinoma

Keywords

Reduced target; Nasopharyngeal Carcinoma; Radiotherapy

Outcome Measures

Primary Outcomes (1)

• 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 (5)

• locoregional recurrence-free survival

  up to 1 year

• Distant metastasis-free survival

  up to 1 years

• Overall survival

  up to 1 years

• Progress Free Survival

  up to 1 years

• Acute radiation toxicity

  up to 3 months

Study Arms (1)

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

Target range RADIATION

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

Reduced target radiotherapy

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• First Affiliated Hospital of Kunming Medical University: lead

Study Sites (1)

First Affiliated Hospital of Kunming Medical University

Kunming, Yunnan, 650032, China

Location

MeSH Terms

Conditions

Nasopharyngeal Carcinoma

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Nasopharyngeal Neoplasms; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD,Phd

Study Record Dates

• First Submitted: February 11, 2023
• First Posted: February 23, 2023
• Study Start: January 1, 2023
• Primary Completion: March 25, 2025
• Study Completion: March 25, 2025
• Last Updated: April 27, 2025

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)