Nasopharyngeal CarcinomaNCT03346109
To Study the Feasibility and Quality of Life of Medial Group Retropharyngeal Node Sparing in Nasopharyngeal Carcinoma
A study testing medial group retropharyngeal node（MRLN） sparing in people with Nasopharyngeal Carcinoma, run by Sun Yat-sen University at 1 site in China.
Trial summary
This is an randomized, controlled, phase 3 clinical trial. The purpose of this study is to evaluate whether medial group retropharyngeal node （MRLN） sparing could reduce the incidence of radiation-caused dysphagia and improve patients' quality of life without compromising survival rate. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Nasopharyngeal Carcinoma
- What is being tested?
- medial group retropharyngeal node（MRLN） sparing
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 568 participants
- Where
- 1 siteChina
- Study dates
- 16 Nov 2017to 30 Dec 2022
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients without medial group retropharyngeal node metastasis;
- Patients with newly histologically confirmed non-keratinizing (according to WHO histologically type);
- Tumor staged as T1-4N0-3(according to the 8th AJCC edition);
- No evidence of distant metastasis (M0);
- Satisfactory performance status: Karnofsky scale (KPS) ≥ 70;
- Patients must be informed of the investigational nature of this study and give written informed consent.
Who cannot join
- Patients with medial group retropharyngeal node metastasis;
- Aged > 65 or < 18;
- Treatment with palliative intent;
- Prior malignancy except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer;
- Pregnancy or lactation (consider pregnancy test in women of child-bearing age and emphasize effective contraception during the treatment period);
- With history of previous RT (except for non-melanomatous skin cancers outside intended RT treatment volume);
- Prior chemotherapy or surgery (except diagnostic) to primary tumor or nodes;
- Any severe intercurrent disease, which may bring unacceptable risk or affect the compliance of the trial.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Randomised Controlled Non-inferior Trial Studying the Feasibility and Potential Quality of Life Benefits of Medial Group Retropharyngeal Node Sparing in Nasopharyngeal Carcinoma
This is an randomized, controlled, phase 3 clinical trial. The purpose of this study is to evaluate whether medial group retropharyngeal node （MRLN） sparing could reduce the incidence of radiation-caused dysphagia and improve patients' quality of life without compromising survival rate.
Read the detailed description
In this study, patients with non-keratinizing stage T1-4 N0-3 M0 NPC(UICC/AJCC 8th edition), except for patients with MRLN metastasis, are randomly assigned to receive MRLN sparing or prophylactic irradiation . Patients in MRLN sparing group will not routinely receive MRLN irradiation to 56Gy/33Fr; while patients in MRLN prophylactic irradiation group will always receive MRLN irradiation to 56Gy/33Fr. Our primary endpoint is local relapse-free survival (LRFS). Secondary end points include overall survival (OS), incidence of out-field recurrence rate, toxic effects, and quality of life (QOL).All efficacy analyses are conducted in the intention-to treat population, and the safety population include only patients who receive their randomly assigned treatment.
- Conditions
- Nasopharyngeal Carcinoma
- Being tested
- medial group retropharyngeal node（MRLN） sparing
- Keywords
- Nasopharyngeal Carcinoma, medial group retropharyngeal node
- Medical subject headings
- Nasopharyngeal Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
medial group retropharyngeal node（MRLN） sparingRadiation
Patients in MRLN sparing group will not routinely receive MRLN irradiation; while patients in MRLN prophylactic irradiation group will always receive MRLN irradiation to 56Gy/33Fr.
| Study group | Role | What they receive |
|---|---|---|
| MRLN sparing group | Experimental | Patients in medial group retropharyngeal node（MRLN） sparing group will not routinely receive MRLN irradiation to 56Gy/33Fr Receives: Radiation: medial group retropharyngeal node（MRLN） sparing |
| MRLN prophylactic irradiation group | No intervention | Patients in MRLN prophylactic irradiation group will always receive MRLN irradiation to 56Gy/33Fr |
What is being measured
The primary outcome is the main question the study is designed to answer.
Local replase-free survival rate
Local failure-free survival is calculated from randomization to the first local failure
Measured: 3 Year
Secondary outcomes (4)
Incidence of acute and late toxicity
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Measured: 1 year
Incidence of out-field recurrence rate
Number of participants with out-field recurrence
Measured: 3 Year
Dysphagia related quality of life
Quality of life (QOL) as assessed by EORTC quality of life questionnaire(QLQ)-HN35
Measured: 1 year
Overall survival
Overall survival is calculated from randomization to death from any cause
Measured: 3 Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2017
- Study start16 Nov 2017
- Primary completion5 Dec 2021
- Study completion30 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Nasopharyngeal CarcinomaStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 568 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jun Ma, MD, Sun Yat-sen University
- Investigators
- Jun Ma, M.D., Study chair, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03346109
- Sponsor's protocol ID
- 2017-FXY-114
- Status last verified
- Apr 2022
- First submitted
- 15 Nov 2017
- Last updated
- 6 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Wang SX, Tao YL, Gao TS, Zhang N, Zhou GQ, Xie FY, Zhang Y, Guo R, Yang Y, Li YJ, Liang SQ, Zeng YC, Lin L, Li WF, Liu X, Xu C, Chen YP, Lv JW, Liu LZ, Li HJ, Li JB, Wen HM, Sun Y, Tang LL, Liang XY, Ma J, Mao YP. Medial retropharyngeal nodal region sparing radiotherapy in nasopharyngeal carcinoma: five year analysis of open label, non-inferiority, multicentre, randomised phase 3 trial. BMJ. 2026 Mar 31;392:e086050. doi: 10.1136/bmj-2025-086050.
PubMed 41916649Mao YP, Wang SX, Gao TS, Zhang N, Liang XY, Xie FY, Zhang Y, Zhou GQ, Guo R, Luo WJ, Li YJ, Liang SQ, Lin L, Li WF, Liu X, Xu C, Chen YP, Lv JW, Huang SH, Liu LZ, Li JB, Tang LL, Chen L, Sun Y, Ma J. Medial retropharyngeal nodal region sparing radiotherapy versus standard radiotherapy in patients with nasopharyngeal carcinoma: open label, non-inferiority, multicentre, randomised, phase 3 trial. BMJ. 2023 Feb 6;380:e072133. doi: 10.1136/bmj-2022-072133.
PubMed 36746459
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomised Controlled Non-inferior Trial Studying the Feasibility and Potential Quality of Life Benefits of Medial Group Retropharyngeal Node Sparing in Nasopharyngeal Carcinoma
- ClinicalTrials.gov ID
- NCT03346109
- Acronym / sponsor ID
- 2017-FXY-114
- Conditions
- Nasopharyngeal Carcinoma
- Keywords
- Nasopharyngeal Carcinoma, medial group retropharyngeal node
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 568 participants (actual)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 16 Nov 2017 (actual)
- Primary completion
- 5 Dec 2021 (actual)
- Study completion
- 30 Dec 2022 (estimated)
- First posted
- 17 Nov 2017 (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 is an randomized, controlled, phase 3 clinical trial. The purpose of this study is to evaluate whether medial group retropharyngeal node （MRLN） sparing could reduce the incidence of radiation-caused dysphagia and improve patients' quality of life without compromising survival rate.
Detailed description
In this study, patients with non-keratinizing stage T1-4 N0-3 M0 NPC(UICC/AJCC 8th edition), except for patients with MRLN metastasis, are randomly assigned to receive MRLN sparing or prophylactic irradiation . Patients in MRLN sparing group will not routinely receive MRLN irradiation to 56Gy/33Fr; while patients in MRLN prophylactic irradiation group will always receive MRLN irradiation to 56Gy/33Fr. Our primary endpoint is local relapse-free survival (LRFS). Secondary end points include overall survival (OS), incidence of out-field recurrence rate, toxic effects, and quality of life (QOL).All efficacy analyses are conducted in the intention-to treat population, and the safety population 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 |
|---|---|---|
| MRLN sparing group | Experimental | Radiation: medial group retropharyngeal node（MRLN） sparingPatients in medial group retropharyngeal node（MRLN） sparing group will not routinely receive MRLN irradiation to 56Gy/33Fr |
| MRLN prophylactic irradiation group | No intervention | –Patients in MRLN prophylactic irradiation group will always receive MRLN irradiation to 56Gy/33Fr |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients without medial group retropharyngeal node metastasis;
- Patients with newly histologically confirmed non-keratinizing (according to WHO histologically type);
- Tumor staged as T1-4N0-3(according to the 8th AJCC edition);
- No evidence of distant metastasis (M0);
- Satisfactory performance status: Karnofsky scale (KPS) ≥ 70;
Key exclusion criteria (8 listed)
- Patients with medial group retropharyngeal node metastasis;
- Aged > 65 or < 18;
- Treatment with palliative intent;
- Prior malignancy except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer;
- Pregnancy or lactation (consider pregnancy test in women of child-bearing age and emphasize effective contraception during the treatment period);
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 |
|---|---|---|
| medial group retropharyngeal node（MRLN） sparingPatients in MRLN sparing group will not routinely receive MRLN irradiation; while patients in MRLN prophylactic irradiation group will always receive MRLN irradiation to 56Gy/33Fr. | Radiation | MRLN sparing group |
Primary outcome
Local replase-free survival rate
Time frame: 3 Year
Local failure-free survival is calculated from randomization to the first local failure
4 secondary outcomes
Incidence of acute and late toxicity
Time frame: 1 year
Incidence of out-field recurrence rate
Time frame: 3 Year
Dysphagia related quality of life
Time frame: 1 year
Overall survival
Time frame: 3 Year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2022.
- Derived from this study: PubMed 41916649Wang SX, Tao YL, Gao TS, Zhang N, Zhou GQ, Xie FY, Zhang Y, Guo R, Yang Y, Li YJ, Liang SQ, Zeng YC, Lin L, Li WF, Liu X, Xu C, Chen YP, Lv JW, Liu LZ, Li HJ, Li JB, Wen HM, Sun Y, Tang LL, Liang XY, Ma J, Mao YP. Medial retropharyngeal nodal region sparing radiotherapy in nasopharyngeal carcinoma: five year analysis of open label, non-inferiority, multicentre, randomised phase 3 trial. BMJ. 2026 Mar 31;392:e086050. doi: 10.1136/bmj-2025-086050.
- Derived from this study: PubMed 36746459Mao YP, Wang SX, Gao TS, Zhang N, Liang XY, Xie FY, Zhang Y, Zhou GQ, Guo R, Luo WJ, Li YJ, Liang SQ, Lin L, Li WF, Liu X, Xu C, Chen YP, Lv JW, Huang SH, Liu LZ, Li JB, Tang LL, Chen L, Sun Y, Ma J. Medial retropharyngeal nodal region sparing radiotherapy versus standard radiotherapy in patients with nasopharyngeal carcinoma: open label, non-inferiority, multicentre, randomised, phase 3 trial. BMJ. 2023 Feb 6;380:e072133. doi: 10.1136/bmj-2022-072133.
- Individual participant dataSharing planned: Undecided
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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.
Jun Ma, M.D. study chair
Sun Yat-sen 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 medial group retropharyngeal node（MRLN） sparing in people with Nasopharyngeal Carcinoma, run by Sun Yat-sen 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 6 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 6 Apr 2022. 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?
Results are not available in the source record.
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?
Local replase-free survival rate (time frame: 3 Year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03346109, which also lists 2 linked publications.
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 6 Apr 2022.