Nasopharyngeal CarcinomaPhase 3PROTECT-NPCNCT06752239
Prophylactic Radiotherapy Optimization for Enhanced Thyroid Function Protection in NPC
A Phase 3 study testing Modified delineation and Standard delineation in people with Nasopharyngeal Carcinoma and Quality of Life, run by Jiangxi Provincial Cancer Hospital at 1 site in China.
Trial summary
This study is a multicenter, non-inferiority, open-label, randomized controlled Phase III clinical trial. It aims to compare the efficacy of modified delineation radiotherapy (experimental group) versus standard delineation radiotherapy (control group) in the prophylactic irradiation of neck lymphatic drainage areas… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Nasopharyngeal Carcinoma, Quality of Life, Thyroid Diseases
- What is being tested?
- Modified delineation and Standard delineation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 474 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2025to 31 Dec 2031
- 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
- 1. Male or female, aged 18-70 years; 2. Pathologically confirmed nasopharyngeal carcinoma; 3. No positive lymph nodes in unilateral or bilateral regions III and IVa; 4. Clinical stage I-IVa (AJCC/UICC 8th edition), with no evidence of distant metastasis; 5. Normal thyroid function; 6. ECOG performance status of 0-1; 7. Treatment-naïve patients who have not received any prior antitumor therapy; 6. No contraindications to radiotherapy or chemotherapy; 9. Adequate organ function, meeting the following criteria: Hematologic criteria: WBC ≥ 4.0 × 10⁹/L, ANC ≥ 1.5 × 10⁹/L, PLT ≥ 100 × 10⁹/L, HGB ≥ 90 g/L (no transfusion, blood products, or hematopoietic growth factors used within the past 7 days); Biochemical criteria: ALT and AST < 1.5 × ULN, ALP < 2.5 × ULN, total bilirubin < ULN, BUN and creatinine ≤ 1.5 × ULN or creatinine clearance rate ≥ 60 mL/min (calculated using the Cockcroft-Gault formula).
- 10. Voluntarily agreed to participate in the study, signed the informed consent form, demonstrated good compliance, and agreed to follow-up.
Who cannot join
- History of other malignant tumors (excluding basal cell carcinoma/squamous cell carcinoma of the skin or cervical carcinoma in situ);
- History of radiotherapy (excluding radiotherapy outside the planned target area for conditions such as melanoma);
- History of neck surgery;
- Any severe comorbidities that may pose risks to the study or affect compliance, such as unstable heart disease requiring treatment, kidney disease, chronic hepatitis, poorly controlled diabetes (fasting blood glucose > 1.5 × ULN), or psychiatric disorders;
- History of hyperthyroidism, hypothyroidism, or immune-related thyroid disorders;
- Other family or social factors, as judged by the investigator, may force the study's early termination, compromise patient safety, or affect the collection of trial data.
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
Jiangxi Cancer Hospital
Nanchang, Jiangxi, 330029
Jingao Li, PhD, 15270186250, ndzhlyy0005@ncu.edu
Xiaochang Gong, M.D.
About this study
Official title: Prophylactic Radiotherapy Optimization for Enhanced Thyroid Function Protection in Nasopharyngeal Carcinoma (PROTECT-NPC): A Multicenter, Non-Inferiority, Open-Label, Randomized Controlled Phase III Clinical Trial
This study is a multicenter, non-inferiority, open-label, randomized controlled Phase III clinical trial. It aims to compare the efficacy of modified delineation radiotherapy (experimental group) versus standard delineation radiotherapy (control group) in the prophylactic irradiation of neck lymphatic drainage areas III/IVa in nasopharyngeal carcinoma. The study evaluates the incidence of primary hypothyroidism, quality of life, and adverse events between the two groups.
- Conditions
- Nasopharyngeal Carcinoma, Quality of Life, Thyroid Diseases, Radiotherapy Side Effect, Radiotherapy
- Being tested
- Modified delineation, Standard delineation
- Keywords
- Nasopharyngeal Carcinoma, Quality of Life, Thyroid Function Protection, Radiotherapy
- Medical subject headings
- Nasopharyngeal Carcinoma, Thyroid Diseases, Radiation Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modified delineationRadiation
Also called MD
Modified delineation (MD) of cervical lymphatic drainage areas, sparing the common carotid artery within the clinical target volume (CTV)
Standard delineationRadiation
Standard delineation
| Study group | Role | What they receive |
|---|---|---|
| Standard delineation | Active comparator | The medial edge of the level III-IVa lymphatic drainage areas was the medial edge to encompass the common carotid artery. And the anterior boundary of the level III-IVa drainage area as the anterior edge of the common carotid artery or posterior edge of the thyrohyoid muscle rather than the anterior edge of the sternocleidomastoid muscle or the posterior third of the thyrohyoid muscle, to reduce thyroid radiation exposure Receives: Radiation: Standard delineation |
| Modified delineation | Experimental | The medial edge of the level III-IVa lymphatic drainage areas was redefined to the lateral edge of the common carotid artery, sparing the common carotid artery area. The anterior boundary of the level III-IVa drainage area as the anterior edge of the common carotid artery or posterior edge of the thyrohyoid muscle, rather than the anterior edge of the sternocleidomastoid muscle or the posterior third of the thyrohyoid muscle, to reduce thyroid radiation exposure. Receives: Radiation: Modified delineation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Regional Recurrence-free Survival
Regional Recurrence-Free Survival (RRFS) is defined as the time interval from the date of randomization to the date of lymph node failure in the cervical lymphatic drainage area or the last follow-up date.
Measured: 3 years
Secondary outcomes (5)
Overall Survival
Overall Survival (OS) is defined as the time interval from the date of randomization to the date of death from any cause or the last follow-up date.
Measured: 3 years
Disease-free Survival
Disease-Free Survival (DFS) is defined as the time interval from the date of randomization to the date of tumor recurrence or death from any cause.
Measured: 3 years
Hypothyroidism-Free Survival
Hypothyroidism-free survival is defined as the time interval from the date of randomization to the date of the first occurrence of hypothyroidism or the last follow-up date.
Measured: 3 years
Clinical Hypothyroidism-Free Survival
Clinical hypothyroidism-free survival is defined as the time interval from the date of randomization to the date of the first occurrence of clinical hypothyroidism or the last follow-up date.
Measured: 3 years
Global Health Status
The quality of life of patients in the two groups will be assessed using the EORTC QLQ-C30 (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30).
Measured: 1year, 2 year and 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2024
- Study start1 Jan 2025
- Primary completion31 Dec 2030 (estimated)
- Study completion31 Dec 2031 (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.
- 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
- Jiangxi Provincial Cancer Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jingao Li, Jiangxi Provincial Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06752239
- Sponsor's protocol ID
- PROTECT-NPC
- Acronym
- PROTECT-NPC
- Status last verified
- Apr 2025
- First submitted
- 21 Dec 2024
- Last updated
- 10 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prophylactic Radiotherapy Optimization for Enhanced Thyroid Function Protection in Nasopharyngeal Carcinoma (PROTECT-NPC): A Multicenter, Non-Inferiority, Open-Label, Randomized Controlled Phase III Clinical Trial
- ClinicalTrials.gov ID
- NCT06752239
- Acronym / sponsor ID
- PROTECT-NPC / PROTECT-NPC
- Conditions
- Nasopharyngeal Carcinoma, Quality of Life, Thyroid Diseases, Radiotherapy Side Effect, Radiotherapy
- Keywords
- Nasopharyngeal Carcinoma, Quality of Life, Thyroid Function Protection, Radiotherapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 474 participants (estimated)
- Lead sponsor
- Jiangxi Provincial Cancer HospitalUniversity, hospital or other
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 31 Dec 2030 (estimated)
- Study completion
- 31 Dec 2031 (estimated)
- First posted
- 30 Dec 2024 (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.
This study is a multicenter, non-inferiority, open-label, randomized controlled Phase III clinical trial. It aims to compare the efficacy of modified delineation radiotherapy (experimental group) versus standard delineation radiotherapy (control group) in the prophylactic irradiation of neck lymphatic drainage areas III/IVa in nasopharyngeal carcinoma. The study evaluates the incidence of primary hypothyroidism, quality of life, and adverse events between the two groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard delineation | Active comparator | Radiation: Standard delineationThe medial edge of the level III-IVa lymphatic drainage areas was the medial edge to encompass the common carotid artery. And the anterior boundary of the level III-IVa drainage area as the anterior edge of the common carotid artery or posterior edge of the thyrohyoid muscle rather than the anterior edge of the sternocleidomastoid muscle or the posterior third of the thyrohyoid muscle, to reduce thyroid radiation exposure |
| Modified delineation | Experimental | Radiation: Modified delineationThe medial edge of the level III-IVa lymphatic drainage areas was redefined to the lateral edge of the common carotid artery, sparing the common carotid artery area. The anterior boundary of the level III-IVa drainage area as the anterior edge of the common carotid artery or posterior edge of the thyrohyoid muscle, rather than the anterior edge of the sternocleidomastoid muscle or the posterior third of the thyrohyoid muscle, to reduce thyroid radiation exposure. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 1. Male or female, aged 18-70 years; 2. Pathologically confirmed nasopharyngeal carcinoma; 3. No positive lymph nodes in unilateral or bilateral regions III and IVa; 4. Clinical stage I-IVa (AJCC/UICC 8th edition), with no evidence of distant metastasis; 5. Normal thyroid function; 6. ECOG performance status of 0-1; 7. Treatment-naïve patients who have not received any prior antitumor therapy; 6. No contraindications to radiotherapy or chemotherapy; 9. Adequate organ function, meeting the following criteria: Hematologic criteria: WBC ≥ 4.0 × 10⁹/L, ANC ≥ 1.5 × 10⁹/L, PLT ≥ 100 × 10⁹/L, HGB ≥ 90 g/L (no transfusion, blood products, or hematopoietic growth factors used within the past 7 days); Biochemical criteria: ALT and AST < 1.5 × ULN, ALP < 2.5 × ULN, total bilirubin < ULN, BUN and creatinine ≤ 1.5 × ULN or creatinine clearance rate ≥ 60 mL/min (calculated using the Cockcroft-Gault formula).
- 10. Voluntarily agreed to participate in the study, signed the informed consent form, demonstrated good compliance, and agreed to follow-up.
Key exclusion criteria (6 listed)
- History of other malignant tumors (excluding basal cell carcinoma/squamous cell carcinoma of the skin or cervical carcinoma in situ);
- History of radiotherapy (excluding radiotherapy outside the planned target area for conditions such as melanoma);
- History of neck surgery;
- Any severe comorbidities that may pose risks to the study or affect compliance, such as unstable heart disease requiring treatment, kidney disease, chronic hepatitis, poorly controlled diabetes (fasting blood glucose > 1.5 × ULN), or psychiatric disorders;
- History of hyperthyroidism, hypothyroidism, or immune-related thyroid disorders;
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 |
|---|---|---|
| Modified delineationAlso: MDModified delineation (MD) of cervical lymphatic drainage areas, sparing the common carotid artery within the clinical target volume (CTV) | Radiation | Modified delineation |
| Standard delineationStandard delineation | Radiation | Standard delineation |
Primary outcome
Regional Recurrence-free Survival
Time frame: 3 years
Regional Recurrence-Free Survival (RRFS) is defined as the time interval from the date of randomization to the date of lymph node failure in the cervical lymphatic drainage area or the last follow-up date.
5 secondary outcomes
Overall Survival
Time frame: 3 years
Disease-free Survival
Time frame: 3 years
Hypothyroidism-Free Survival
Time frame: 3 years
Clinical Hypothyroidism-Free Survival
Time frame: 3 years
Global Health Status
Time frame: 1year, 2 year and 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 10 Apr 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Modified delineation and Standard delineation in people with Nasopharyngeal Carcinoma and Quality of Life, run by Jiangxi Provincial Cancer Hospital 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 2 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 10 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.
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 Xiaochang Gong, MD (8613970020755, gxcanddw@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Regional Recurrence-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 10 Apr 2025.