Nasopharyngeal CarcinomaPhase 3NCT06775756
Reducing Dose and Irradiated Volume in Cervical Prophylactic Irradiation for Nasopharyngeal Cancer
A Phase 3 study testing IMRT with reduced-dose and reduced-volume cervical prophylactic irradiation in people with Nasopharyngeal Carcinoma, run by Fujian Cancer Hospital.
Trial summary
The purpose of this study is to investigate whether reducing both the dose and the irradiated volume of cervical prophylactic irradiation in patients with nasopharyngeal cancer can maintain efficacy while decreasing toxicity. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Nasopharyngeal Carcinoma
- What is being tested?
- IMRT with reduced-dose and reduced-volume cervical prophylactic irradiation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 474 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2025to 1 Apr 2030
- Phase
- Phase 3
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pathologic diagnosis (pathologically confirmed by nasopharyngeal biopsy) was nasopharyngeal carcinoma;
- No distant metastatic;
- Patients with baseline MRI date of nasopharynx and neck, and completed the first course of treatment in our hospital;
- Eastern Cooperative Oncology Group (ECOG) score of 0 or 1;
- Signing informed consent;
- Follow up regularly and comply with test requirements.
Who cannot join
- Disease progression during IMRT;
- Previous malignancy or other concomitant malignant diseases;
- The evaluation information of tumor efficacy can not be obtained;
- Receive blind treatment in other clinical research;
- Have or are suffering from other malignant tumors within 5 years (except non- melanoma skin cancer or pre-invasive cervical cancer);
- Serious complications, such as uncontrolled hypertension, coronary heart disease, diabetes, heart failure, etc;
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- Active systemic infection;
- No or limited capacity for civil conduct;
- The patient has a physical or mental disorder, and the researcher considers that the patient is unable to fully or fully understand the possible complications of this study;
- Pregnancy or lactation period;
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Phase 3, Prospective, Randomized, Open-Label Study on Simultaneously Reducing Both the Dose and the Irradiated Volume of Cervical Prophylactic Irradiation in Nasopharyngeal Cancer
The purpose of this study is to investigate whether reducing both the dose and the irradiated volume of cervical prophylactic irradiation in patients with nasopharyngeal cancer can maintain efficacy while decreasing toxicity. This will be achieved through a comparison of standard cervical prophylactic irradiation with a reduced-dose and reduced-volume approach.
Read the detailed description
Patients with non-metastatic nasopharyngeal cancer who are candidates for receiving definitive IMRT are randomly assigned to receive either standard cervical prophylactic irradiation or a reduced-dose and reduced-volume approach. The standard arm receives the conventional dose and volume of irradiation, while the experimental arm receives a lower dose and a smaller irradiated volume. Both groups will undergo intensity-modulated radiotherapy (IMRT) to the primary tumor and involved lymph nodes. The primary endpoint of this study is regional-control (RC), and secondary endpoints include overall survival (OS), local control (LC), distant metastasis-free survival (DMFS), and toxicity. All efficacy analyses will be conducted in the intention-to-treat population, and the safety population will include only patients who receive their randomly assigned treatment.
- Conditions
- Nasopharyngeal Carcinoma
- Being tested
- IMRT with reduced-dose and reduced-volume cervical prophylactic irradiation
- Medical subject headings
- Nasopharyngeal Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IMRT with reduced-dose and reduced-volume cervical prophylactic irradiationRadiation
For N0 disease, only cover bilateral RPN and level II. For N1 disease, cover ipsilateral involved level plus subsequent level downword, and cover contralateral level RPN and level II. For N2 disease, cover ipsilateral involved level plus subsequent level downword. For N3 disease, cover ipsilateral involved level plus subsequent level downword, and ensuring a 2cm margin below GTVn if GTVn reach or near the sternoclavicular joint. Notably, for unilateral N3, the contralateral neck would only include RPN and level II. Prescribing dose for CTVn2 was 50Gy/33Fx.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | The experimental arm receives IMRT to the primary tumor and involved lymph nodes, with a reduced dose and volume of cervical prophylactic irradiation. Receives: Radiation: IMRT with reduced-dose and reduced-volume cervical prophylactic irradiation |
| Control Group | No intervention | The standard arm receives IMRT to the primary tumor and involved lymph nodes, with conventional cervical prophylactic irradiation according to 2024 CSCO guideline. Prescribing dose for CTVn2 was 56Gy/33Fx. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Regional failure-free survival
The regional relapse-free survival rate will be estimated using Kaplan-Meier method for each arm from the date of randomization to the date of nodal relapse or death from any cause, whichever occurred first. Their differences will be compared between treatment arms using the log-rank test.
Measured: 3 years
Secondary outcomes (5)
Overall Survival
time from the date of the start of chemotherapy to death due to any cause
Measured: 3 years
Local failure-free survival (LFFS)
The duration of time to LFFS was calculated from the date of histological diagnosis until documented treatment local failure or death from any cause.
Measured: 3 years
Distant metastasis-free survival
The distant metastasis-free survival rate will be estimated using Kaplan-Meier
Measured: 3 years
Number of participants with adverse events
Measured: 3 years
Incidence of acute and late toxicity
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2025
- Study start1 Apr 2025 (estimated)
- Primary completion1 Apr 2027 (estimated)
- Study completion1 Apr 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nasopharyngeal CarcinomaStudies of the same condition, open and under way.
- More trials run by Fujian Cancer HospitalThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 474 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fujian Cancer Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Shaojun Lin, DR, Study chair, Fujian Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06775756
- Sponsor's protocol ID
- CerviReduce
- Status last verified
- Jan 2025
- First submitted
- 10 Jan 2025
- Last updated
- 15 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 3, Prospective, Randomized, Open-Label Study on Simultaneously Reducing Both the Dose and the Irradiated Volume of Cervical Prophylactic Irradiation in Nasopharyngeal Cancer
- ClinicalTrials.gov ID
- NCT06775756
- Acronym / sponsor ID
- CerviReduce
- Conditions
- Nasopharyngeal Carcinoma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 474 participants (estimated)
- Lead sponsor
- Fujian Cancer HospitalOther government
- Study start
- 1 Apr 2025 (estimated)
- Primary completion
- 1 Apr 2027 (estimated)
- Study completion
- 1 Apr 2030 (estimated)
- First posted
- 15 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 is to investigate whether reducing both the dose and the irradiated volume of cervical prophylactic irradiation in patients with nasopharyngeal cancer can maintain efficacy while decreasing toxicity. This will be achieved through a comparison of standard cervical prophylactic irradiation with a reduced-dose and reduced-volume approach.
Detailed description
Patients with non-metastatic nasopharyngeal cancer who are candidates for receiving definitive IMRT are randomly assigned to receive either standard cervical prophylactic irradiation or a reduced-dose and reduced-volume approach. The standard arm receives the conventional dose and volume of irradiation, while the experimental arm receives a lower dose and a smaller irradiated volume. Both groups will undergo intensity-modulated radiotherapy (IMRT) to the primary tumor and involved lymph nodes. The primary endpoint of this study is regional-control (RC), and secondary endpoints include overall survival (OS), local control (LC), distant metastasis-free survival (DMFS), and toxicity. All efficacy analyses will be conducted in the intention-to-treat population, and the safety population will include only patients who receive their randomly assigned treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Radiation: IMRT with reduced-dose and reduced-volume cervical prophylactic irradiationThe experimental arm receives IMRT to the primary tumor and involved lymph nodes, with a reduced dose and volume of cervical prophylactic irradiation. |
| Control Group | No intervention | –The standard arm receives IMRT to the primary tumor and involved lymph nodes, with conventional cervical prophylactic irradiation according to 2024 CSCO guideline. Prescribing dose for CTVn2 was 56Gy/33Fx. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Pathologic diagnosis (pathologically confirmed by nasopharyngeal biopsy) was nasopharyngeal carcinoma;
- No distant metastatic;
- Patients with baseline MRI date of nasopharynx and neck, and completed the first course of treatment in our hospital;
- Eastern Cooperative Oncology Group (ECOG) score of 0 or 1;
- Signing informed consent;
Key exclusion criteria (10 listed)
- Disease progression during IMRT;
- Previous malignancy or other concomitant malignant diseases;
- The evaluation information of tumor efficacy can not be obtained;
- Receive blind treatment in other clinical research;
- Have or are suffering from other malignant tumors within 5 years (except non- melanoma skin cancer or pre-invasive cervical cancer);
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 |
|---|---|---|
| IMRT with reduced-dose and reduced-volume cervical prophylactic irradiationFor N0 disease, only cover bilateral RPN and level II. For N1 disease, cover ipsilateral involved level plus subsequent level downword, and cover contralateral level RPN and level II. For N2 disease, cover ipsilateral involved level plus subsequent level downword. For N3 disease, cover ipsilateral involved level plus subsequent level downword, and ensuring a 2cm margin below GTVn if GTVn reach or near the sternoclavicular joint. Notably, for unilateral N3, the contralateral neck would only include RPN and level II. Prescribing dose for CTVn2 was 50Gy/33Fx. | Radiation | Experimental Group |
Primary outcome
Regional failure-free survival
Time frame: 3 years
The regional relapse-free survival rate will be estimated using Kaplan-Meier method for each arm from the date of randomization to the date of nodal relapse or death from any cause, whichever occurred first. Their differences will be compared between treatment arms using the log-rank test.
5 secondary outcomes
Overall Survival
Time frame: 3 years
Local failure-free survival (LFFS)
Time frame: 3 years
Distant metastasis-free survival
Time frame: 3 years
Number of participants with adverse events
Time frame: 3 years
Incidence of acute and late toxicity
Time frame: 3 years
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 15 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.
Shaojun Lin, DR study chair
Fujian Cancer Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing IMRT with reduced-dose and reduced-volume cervical prophylactic irradiation in people with Nasopharyngeal Carcinoma, run by Fujian Cancer Hospital.
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 6 inclusion and 10 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: opening soon, as of the sponsor's last update on 15 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Shaojun Lin, DR (13860603879, linshaojun@yeah.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Regional failure-free survival (time frame: 3 years). 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 15 Jan 2025.