Toxicity Due to RadiotherapyNCT05741008
Clincal Study of Reduced Target Radiotherapy in Nasopharyngeal Carcinoma
A study testing Target range in people with Toxicity Due to Radiotherapy and Nasopharyngeal Carcinoma, run by First Affiliated Hospital of Kunming Medical University at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Toxicity Due to Radiotherapy, Nasopharyngeal Carcinoma
- What is being tested?
- Target range
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2023to 25 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
First Affiliated Hospital of Kunming Medical University
Kunming, Yunnan, 650032
About this study
Official title: Clincal Study of Reduced Target Radiotherapy Based on The Law and Distribution Characteristics of Cervical Lymph Nodes Metastasis 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.
- Being tested
- Target range
- Keywords
- Reduced target, Nasopharyngeal Carcinoma, Radiotherapy
- Medical subject headings
- Nasopharyngeal Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Target rangeRadiation
Compared with conventional radiotherapy, the target dose is unchanged and the CTV2 volume is reduced.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Radiation: Target range |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: up to 6 months
Secondary outcomes (5)
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
Measured: up to 1 year
Distant metastasis-free survival
The time from date of treatment until date of death due to any cause, assessed up to 1 years.
Measured: up to 1 years
Overall survival
The time from date of treatment until date of death due to any cause, assessed up to 1 years.
Measured: up to 1 years
Progress Free Survival
The time from date of treatment until date of death due to any cause, assessed up to 1 years.
Measured: up to 1 years
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.
Measured: up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2023
- Study start1 Jan 2023
- Primary completion25 Mar 2025
- Study completion25 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Toxicity Due to RadiotherapyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital of Kunming Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhiqiang, Wang, First Affiliated Hospital of Kunming Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05741008
- Sponsor's protocol ID
- 2021BS005
- Status last verified
- Feb 2023
- First submitted
- 11 Feb 2023
- Last updated
- 27 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clincal Study of Reduced Target Radiotherapy Based on The Law and Distribution Characteristics of Cervical Lymph Nodes Metastasis in Nasopharyngeal Carcinoma
- ClinicalTrials.gov ID
- NCT05741008
- Acronym / sponsor ID
- 2021BS005
- Keywords
- Reduced target, Nasopharyngeal Carcinoma, Radiotherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- First Affiliated Hospital of Kunming Medical UniversityUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 25 Mar 2025 (actual)
- Study completion
- 25 Mar 2025 (actual)
- First posted
- 23 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Reduced target radiotherapy | Experimental | Radiation: Target rangeAccording 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). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (9 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Target rangeCompared with conventional radiotherapy, the target dose is unchanged and the CTV2 volume is reduced. | Radiation | Reduced target radiotherapy |
Primary outcome
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
5 secondary outcomes
locoregional recurrence-free survival
Time frame: up to 1 year
Distant metastasis-free survival
Time frame: up to 1 years
Overall survival
Time frame: up to 1 years
Progress Free Survival
Time frame: up to 1 years
Acute radiation toxicity
Time frame: up to 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Target range in people with Toxicity Due to Radiotherapy and Nasopharyngeal Carcinoma, run by First Affiliated Hospital of Kunming Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
incidence of acute mucosal ulcers with a toxicity grade 3 or above (time frame: up to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2025.