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NCT Number: NCT05741008

Clincal Study of Reduced Target Radiotherapy in Nasopharyngeal Carcinoma

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.

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Key information

Conditions

Toxicity Due to Radiotherapy Carcinoma Head and Neck Neoplasms Nasopharyngeal Carcinoma Nasopharyngeal Diseases Nasopharyngeal Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Otorhinolaryngologic Diseases Otorhinolaryngologic Neoplasms Pharyngeal Diseases Pharyngeal Neoplasms Stomatognathic Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

First Affiliated Hospital of Kunming Medical University

Kunming, Yunnan, 650032, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Target range

Radiation

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

Primary outcomes

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

    Time frame: up to 6 months

    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

Secondary outcomes

  1. locoregional recurrence-free survival

    Time frame: up to 1 year

    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

  2. Distant metastasis-free survival

    Time frame: up to 1 years

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

  3. Overall survival

    Time frame: up to 1 years

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

  4. Progress Free Survival

    Time frame: up to 1 years

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

  5. Acute radiation toxicity

    Time frame: up to 3 months

    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.

Sponsors and collaborators

Lead sponsor

First Affiliated Hospital of Kunming Medical University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Feb 23, 2023
Registry last updated
Apr 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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