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Nasopharyngeal Carcinoma (NPC)NCT06796270

Hypofractionated Radiotherapy for Nasopharyngeal Carcinoma

A study testing Hypofractionated radiotherapy in people with Nasopharyngeal Carcinoma (NPC), run by The Second Affiliated Hospital of Hainan Medical University at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The purpose of this study was to evaluate the efficacy and safety of large fractionation radiotherapy in nasopharyngeal carcinoma patients, and to analyze whether Hypofractionated radiotherapy is not inferior to conventional radiotherapy. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Nasopharyngeal Carcinoma (NPC)
What is being tested?
Hypofractionated radiotherapy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
24 participants
Where
1 siteChina
Study dates
20 Feb 2026to 31 Dec 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

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 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age 18-75 years, male or female;
  • Performance status ≤ 2 ;
  • Nasopharyngeal cancer patients diagnosed by pathology (including histology or cytology) , of nasopharyngeal non-keratonic carcinoma (differentiated or undifferentiated, whether TNM staging);
  • Have at least one evaluable lesion (according to Recist1.1 criteria)
  • Expected survival ≥6 months.
  • The main organs are functioning normally and meet the following standards: (1) Blood routine examination must meet the following criteria: (no blood transfusion within 14 days) a. HB ≥ 100g/L, b. WBC ≥3×10^9/L c. ANC≥1.5×10^9/L, d. PLT ≥100×10^9/L; (2) Biochemical examination must meet the following standards: a. BIL<1.5 times the upper limit of normal value (ULN), b. ALT and AST<2.5ULN, GPT ≤1.5×ULN; c. Serum Cr≤1 ULN, endogenous creatinine clearance rate>60ml/min (Cockcroft Gault formula);(3).Good coagulation function: defined as International standardized ratio (INR) or prothrombin time (PT) ≤1.5×ULN;(4).The myocardial enzyme spectra were in the normal range.
  • Patients willing and able to give signed informed consent and, in the opinion of the Investigator, to comply with the Clinical Investigation Plan tests and procedures.

Who cannot join

  • Pregnant or lactating women
  • As determined by the investigators, there were severe comorbidities that could not tolerate or complete radiation therapy.
  • There are contraindications in MRI;
  • Second primary malignancy exists;
  • Patients with severe complications,such as hypertension, coronary heart disease,mental disease or patients who had any allergies before;
  • Received any other research in the past 4 weeks before enrollment.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

yuecan zeng, doctor contact

19946610752

wellyy2005@hainmc.edu.cn

junnv xu, doctor contact

18208946196

xujunnv@sina.com

China1 site, 1 recruiting
  • The Second Affiliated Hospital of Hainan Medical University

    Haikou, Hainan, 570311

    yuecan zeng, 19946610752, wellyy2005@hainmc.edu.cn

    junnv xu, 18208946196, xujunnv@sina.com

    Recruiting

Other trials in China

About this study

Official title: Efficacy and Safety of Hypofractionated Radiotherapy for Nasopharyngeal Carcinoma

The purpose of this study was to evaluate the efficacy and safety of large fractionation radiotherapy in nasopharyngeal carcinoma patients, and to analyze whether Hypofractionated radiotherapy is not inferior to conventional radiotherapy.

Read the detailed description

Nasopharyngeal carcinoma (NPC) is a type of head and neck malignancies with uneven geographic distribution. According to the World Health Organization, about 40 percent of nasopharyngeal cancer cases occur in China, especially in southern China. Because of the anatomical location, pathological type and biological behavior of nasopharyngeal carcinoma, radiotherapy is the most important treatment method for nasopharyngeal carcinoma. There are four main factors that affect the effect of radiotherapy: (1) repair of radiation damage, (2) repopulation or reproliferation of tumor cells, (3) reoxygenation of hypoxic tumor cells, and (4) redistribution of cell cycle. Reproliferation of surviving tumor cells is one of the important reasons for local failure of conventional frit radiotherapy. The key to improve local control of tumor cells is to overcome the accelerated reproliferation of tumor cells.

Under the conditions of conventional radiotherapy techniques, the organs can be exposed to a large range of radiation, serious damage, difficult to achieve the target dose, and lead to some acute and late toxicity, which may have a negative impact on the patient's quality-of-life (QoL). The conventional segmentation course is too long and the treatment time is too long, thus creating conditions for the accelerated reproliferation of tumor cells, which is not conducive to local control, and has a certain impact on patients in physiological, psychological and economic aspects.

Clinical studies have shown that a variety of human tumors have accelerated reproliferation after conventional radiotherapy, and this reproliferation is closely related to the potential doubling time of tumors. Hypofractionated radiotherapy , also known as low segmentation radiotherapy, refers to the dose segmentation mode with a single radiotherapy dose >2Gy. It can shorten radiotherapy on the premise that the biological effect dose of conventional dose segmentation radiotherapy is equivalent to or increased. It has been widely used in the treatment of a variety of tumors, and is a safe, effective and short course of radiotherapy mode. This method can increase the single dose and shorten the course of treatment, considering the reproliferation of tumor cells and the protection of normal tissues, which is in line with the principle of radiobiology. When the time factor of doubling time days was added, the large segmentation radiotherapy was higher than that of conventional radiotherapy and was consistent with clinical results. Recently, many scholars have made clinical exploration on the technique of Hypofractionated radiotherapy, which provides a new model for radiotherapy. Compared with conventional segmentation, Hypofractionated radiotherapy can give a higher bioeffective dose to the tumor, effectively improve the tumor control rate, shorten the average radiotherapy time by one week, and reduce the reproliferation of tumor cells.

In recent years, with the increasingly detailed optimization of precision radiotherapy technology and the development of radiobiology, Hypofractionated radiotherapy has achieved good therapeutic effects in prostate cancer, lung cancer, liver cancer and breast cancer. Long Bin et al. found that in patients with recurrent nasopharyngeal carcinoma, the duration of Hypofractionated radiotherapy is significantly shorter than that of conventional fractionated radiotherapy, which reduces part of the radiation damage reaction, increases the equivalent biological dose, and can significantly increase the Tumor Control Probability (TCP), with good short-term and long-term efficacy. High gain ratio and good safety were obtained. At present, there is no research on Hypofractionated radiotherapy in nasopharyngeal carcinoma patients at home and abroad. At present, conventional segmentation is still advocated, and the conventional mode is 70Gy/35F/7W. However, this dose segmentation mode has negative factors such as multiple patient trips and high medical costs. Radiobiology and a large number of clinical studies have shown that there is accelerated proliferation of tumor cells after radiotherapy, and this accelerated reproliferation is the main reason for radiotherapy failure, thus challenging whether conventional fractionated radiotherapy is the best scheme. A variety of unconventional fractionated radiotherapy schemes such as hyperfractionation, Hypofractionated radiotherapy and late accelerated fractionation have been proposed to improve the therapeutic effect of cancer.

Therefore, we initiated a non-inferior, non-randomized controlled clinical trial to evaluate whether mafrit is comparable to conventional radiotherapy in nasopharyngeal carcinoma patients with a view to further improving the prognosis and quality of life of nasopharyngeal carcinoma patients.

Being tested
Hypofractionated radiotherapy
Keywords
Nasopharyngeal Carcinoma (NPC), Hypofractionated 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.

  • Hypofractionated radiotherapyRadiation

    The patients with nasopharyngeal carcinoma were given the dose of large segmentation radiotherapy, 2.64Gy/ time, 5 times/week, a total of 25 times, a total of 66Gy/5 weeks.

Study groups in NCT06796270
Study groupRoleWhat they receive
Hypofractionated radiotherapyExperimentalThe patients with nasopharyngeal carcinoma were given the dose of large segmentation radiotherapy, 2.64Gy/ time, 5 times/week, a total of 25 times, a total of 66Gy/5 weeks.
Receives: Radiation: Hypofractionated radiotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Objective response rate (ORR)

    overall response rate (ORR) in patients with nasopharyngeal carcinoma treated with Hypofractionated radiotherapy

    Measured: 3 months, 6 months,12 months,24 months,36 months,60 months

Secondary outcomes (6)
  1. Overall survival (months)

    This is defined as the number of months participants survived from completion date of radiation therapy until the date of death. If a participant is alive, the participant censored at the date of last documentation of the patient being alive.

    Measured: 3 months, 6 months,12 months,24 months,36 months,60 months

  2. Progress-free survival (months)

    This is defined as the number of months participants experienced no locoregional recurrence or distant metastasis from completion date of radiation therapy until the date of progression. The date of progression will be defined as the date of initial suspicion for progression by physical exam or imaging studies.Evaluation of Incidence of Treatment-Emergent Adverse Events Patients will be educated and instructed to report any adverse events

    Measured: 3 months, 6 months,12 months,24 months,36 months,60 months

  3. Number acute toxicities

    Number of acute toxicities associated with radiation experienced by participants based on the follow-up assessments at 1-2 weeks, 3 months, 6 months following radiation therapy completion

    Measured: 1-2 weeks, 3 months, 6 months

  4. Number of chronic toxicities

    Number of chronic toxicities associated with radiation experienced by participants based on the follow-up assessments completed at 2 weeks, 3 months, 6 months and 12 months following radiation therapy

    Measured: 2 weeks, 3 months, 6 months and 12 months

  5. Patient reported Health related quality of life (HRQoL)

    Patient reported health related quality of life is captured through a questionnaire the Generic European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30. It is a core scale applicable to all cancer patients. It contains a total of 30 items, items 1 to 28 are divided into 4 grades and scored 1 to 4 points, items 29 and 30 are divided into 7 grades and scored 1 to 7 points. The 30 entries are divided into 15 domains, including 5 functional domains (i.e., somatic, role, cognitive, emotional, and social), 3 symptom domains (i.e., fatigue, pain, nausea, and vomiting), 1 quality of life domain, and 6 single entries/domains. A high score on functional or global health status scale represents a high/healthy level of functioning

    Measured: 2 months

  6. Tolerance and compliance

    The number of patients who received the full course of Hypofractionated radiotherapy.

    Measured: 2 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Jan 2025
  2. Study start20 Feb 2026 (estimated)
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion31 Dec 2028 (estimated)

Resources

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
24 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06796270
Sponsor's protocol ID
2024-K52-01
Status last verified
Jan 2025
First submitted
14 Jan 2025
Last updated
28 Jan 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Hypofractionated radiotherapy in people with Nasopharyngeal Carcinoma (NPC), run by The Second Affiliated Hospital of Hainan 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 7 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 28 Jan 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact yuecan zeng, doctor (19946610752, wellyy2005@hainmc.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective response rate (ORR) (time frame: 3 months, 6 months,12 months,24 months,36 months,60 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 28 Jan 2025.

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