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.
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.
China1 site, 1 recruiting
- 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
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.
- Conditions
- Nasopharyngeal Carcinoma (NPC)
- 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 group | Role | What they receive |
|---|---|---|
| Hypofractionated radiotherapy | Experimental | 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. Receives: Radiation: Hypofractionated radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
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
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
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
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
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
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.
- First posted28 Jan 2025
- Study start20 Feb 2026 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nasopharyngeal Carcinoma (NPC)Studies 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
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Second Affiliated Hospital of Hainan Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- yuecan zeng, doctor, Study director, The Second Affiliated Hospital of Hainan Medical University
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
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Hypofractionated Radiotherapy for Nasopharyngeal Carcinoma
- ClinicalTrials.gov ID
- NCT06796270
- Acronym / sponsor ID
- 2024-K52-01
- Conditions
- Nasopharyngeal Carcinoma (NPC)
- Keywords
- Nasopharyngeal Carcinoma (NPC), Hypofractionated radiotherapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- The Second Affiliated Hospital of Hainan Medical UniversityUniversity, hospital or other
- Study start
- 20 Feb 2026 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 28 Jan 2025 (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.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hypofractionated radiotherapy | Experimental | Radiation: Hypofractionated radiotherapyThe 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (6 listed)
- 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;
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 |
|---|---|---|
| Hypofractionated radiotherapyThe 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. | Radiation | Hypofractionated radiotherapy |
Primary outcome
Objective response rate (ORR)
Time frame: 3 months, 6 months,12 months,24 months,36 months,60 months
overall response rate (ORR) in patients with nasopharyngeal carcinoma treated with Hypofractionated radiotherapy
6 secondary outcomes
Overall survival (months)
Time frame: 3 months, 6 months,12 months,24 months,36 months,60 months
Progress-free survival (months)
Time frame: 3 months, 6 months,12 months,24 months,36 months,60 months
Number acute toxicities
Time frame: 1-2 weeks, 3 months, 6 months
Number of chronic toxicities
Time frame: 2 weeks, 3 months, 6 months and 12 months
Patient reported Health related quality of life (HRQoL)
Time frame: 2 months
Tolerance and compliance
Time frame: 2 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2025.
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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.
yuecan zeng, doctor study director
The Second Affiliated Hospital of Hainan Medical University
1 site in 1 country: see every site and its status.
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.