Nasopharyngeal CarcinomaNCT06688760
Surgery Alone Verus Sugery Combined with Dose-reduced Radiotherapy for Newly Diagnosed Stage I Nasopharyngeal Carcinoma
A study testing Endoscopic nasopharyngectomy combine Retropharyngeal lymphadenectomy and Low Dose Radiotherapy and Endoscopic nasopharyngectomy combine Retropharyngeal lymphadenectomy and Double upper neck lymph node dissection in people with Nasopharyngeal Carcinoma and Surgery, run by Ming-Yuan Chen at 2 sites in China.
Trial summary
The goal of this clinical trial is to compare the efficacy and safety of endoscopic nasopharyngectomy combined with retropharyngeal lymph nodes dissection plus bilateral upper neck lymph node dissection or plus postoperative low-dose radiotherapy in newly diagnosed stage Ⅰ nasopharyngeal carcinoma. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Nasopharyngeal Carcinoma, Surgery, Radiotherapy
- What is being tested?
- Endoscopic nasopharyngectomy combine Retropharyngeal lymphadenectomy and Low Dose Radiotherapy and Endoscopic nasopharyngectomy combine Retropharyngeal lymphadenectomy and Double upper neck lymph node dissection
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 2 sitesChina
- Study dates
- 1 Nov 2023to 1 Nov 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Performance Status Score 0-1 points.
- Non-keratinized carcinoma of the nasopharynx (differentiated or undifferentiated, i.e., WHO type II or III) confirmed histologically and/or cytologically.
- According to the UICC/AJCC eighth edition staging, the patient is defined as T1N0M0 stage I.
- Adequate organ function: WBC ≥ 4×10^9 /L, NEUT ≥ 2×10^6 /L, HGB ≥ 9 g/dL, PLT count ≥ 100×10^9/L, TBIL ≤1.5 ULN, ALT ≤3 ULN, AST ≤3 ULN, ALP ≤3 ULN, ALB ≥ 3 g/dL, INR or APTT≤1.5 ULN, Scr ≤1.5 ULN or Ccr ≥ 60 mL/min.
- Informed Concent signed with willingness to obey the follow-up, treatment, examination and any other programs according to the research protocol.
Who cannot join
- Diagnosed as recurrent or distant metastatic nasopharyngeal carcinoma or together with any other malignancy.
- Suffering severe organ dysfunction or physical disorder which could not tolerate surgery or radiotherapy.
- Unable to cooperate with regular follow-up due to psychological, social, domestic or geological reasons.
- During pregnancy or lactation.
- Other patients that the chief physician considered as illegal for this trial.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
The Fifth Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, 516000
Mingyuan Chen, PhD., +8613903052650, chmingy@mail.sysu.edu.cn
- Recruiting
The Fifth Affiliated Hospital of Sun Yat-sen University
Zhuhai, Guangdong, 519000
Youping Liu, PhD., +8613751763276, liuyp78@email.sysu.edu.cn
About this study
Official title: Endoscopic Nasopharyngectomy Combined with Retropharyngeal Lymph Node Dissection Plus Low-dose Radiotherapy Versus Bilateral Upper Neck Dissection for Newly Diagnosed Stage I Nasopharyngeal Carcinoma: a Randomized Controlled Clinical Trial
The goal of this clinical trial is to compare the efficacy and safety of endoscopic nasopharyngectomy combined with retropharyngeal lymph nodes dissection plus bilateral upper neck lymph node dissection or plus postoperative low-dose radiotherapy in newly diagnosed stage Ⅰ nasopharyngeal carcinoma.
Read the detailed description
At present, the newly diagnosed non metastatic nasopharyngeal carcinoma has achieved good therapeutic effect under the treatment scheme of intensity modulated radiotherapy. The 5-year survival rate of the newly diagnosed stage Ⅰ nasopharyngeal carcinoma was more than 95%. But at the same time, all patients receiving radical radiotherapy will experience different degrees of acute or chronic radiation injury, which will affect the quality of life of patients to varying degrees. For stage Ⅰ nasopharyngeal carcinoma with the primary lesion confined to the nasopharyngeal mucosa and without regional lymph node metastasis, in theory, the primary lesion can be removed by minimally invasive surgery without preventive treatment of cervical lymph nodes.
Our previous research results showed that endoscopic surgery could achieved similar survival outcomes but less adverse events than radiotherapy for Stage Ⅰ nasopharyngeal carcinoma with short diameter of retropharyngeal lymph nodes<0.4cm or short diameter of cervical lymph nodes<0.6 and negative PET/CT findings. However, if there is the same results for all stage I NPC patients is still unclear. Therefore, this study aims to compare the efficacy and safety of endoscopic nasopharyngectomy combined with retropharyngeal lymph node dissection combined with low-dose radiotherapy or bilateral upper neck lymph node dissection compared with conventional intensity-modulated radiotherapy.
When the patients participated in this study, the stage ⅠNPC patient of experimental group 1 received endoscopic nasopharyngectomy combined with retropharyngeal lymph node dissection and low-dose radiotherapy. Low dose radiotherapy target area: CTV1 (tumor bed area); For the primary lesion with negative margin but less than 3mm, the margin area should be included; For patients with extracapsular invasion of lymph nodes, the extracapsular invasion area should be included; It should also include all cervical lymph nodes located above the cricoid cartilage detected by CT/MRI, regardless of size; CTV2: low risk infiltration area. The prescription dose of intensity modulated radiotherapy: CTV1:36.00gy/15fr/2.40gy; CTV2:30.00gy/15fr/2.00gy. The patients in the stage Ⅰ in the experimental group 2 underwent endoscopic nasopharynx resection combined with retropharyngeal lymph node resection and bilateral upper neck lymph node dissection, without radiotherapy or chemotherapy after surgery.
- Conditions
- Nasopharyngeal Carcinoma, Surgery, Radiotherapy
- Being tested
- Endoscopic nasopharyngectomy combine Retropharyngeal lymphadenectomy and Low Dose Radiotherapy, Endoscopic nasopharyngectomy combine Retropharyngeal lymphadenectomy and Double upper neck lymph node dissection
- Medical subject headings
- Nasopharyngeal Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic nasopharyngectomy combine Retropharyngeal lymphadenectomy and Low Dose RadiotherapyProcedure or surgery
in experimental arm 1
Endoscopic nasopharyngectomy combine Retropharyngeal lymphadenectomy and Double upper neck lymph node dissectionProcedure or surgery
in experimental arm 2
| Study group | Role | What they receive |
|---|---|---|
| Surgery plus low dose radiotherapy | Experimental | Surgery:
Endoscopic Nasopharyngectomy: Radical resection of primary lesion using nasal endoscopy.
Retropharyngeal Lymphadenectomy: Radical retropharyngeal LNs resection using nasal endoscopy.
Radiotherapy:
Low Dose Raiotherapy:
Low dose radiotherapy target area: CTV1: tumor bed area; For cases where the margin of the primary lesion is negative but less than 3mm, the margin area should be included; It should also include all cervical lymph nodes located above the cricoid cartilage detected by CT/MRI, regardless of size; CTV2: Low risk infiltration area.
Intensity modulated radiation therapy prescription dose: CTV1: 36.00Gy/15Fr/2.40Gy; CTV2: 30.00Gy/15Fr/2.00Gy. Receives: Procedure: Endoscopic nasopharyngectomy combine Retropharyngeal lymphadenectomy and Low Dose Radiotherapy |
| Surgery | Experimental | Endoscopic Nasopharyngectomy: Radical resection of primary lesion using nasal endoscopy.
Retropharyngeal Lymphadenectomy: Radical retropharyngeal LNs resection using nasal endoscopy.
Bilateral Upper Neck Lymph Node Dissection: the specific cleaning area is the lymph nodes upon the Hyoid bone regions. Receives: Procedure: Endoscopic nasopharyngectomy combine Retropharyngeal lymphadenectomy and Low Dose Radiotherapy; Procedure: Endoscopic nasopharyngectomy combine Retropharyngeal lymphadenectomy and Double upper neck lymph node dissection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Local Regional Relapse-Free Survival (LRRFS)
The LRRFS is evaluated and calculated from the date of random assignment until the day of first local regional relapse or until the date of the last follow-up visit.
Measured: 2 years
Secondary outcomes (7)
The incidence of serious complications
Common Adverse Event Evaluation Criteria (CTCAE) version 5.0 evaluates acute and late-stage subjective toxicity reactions.
Measured: 2 years
Overall Survival (OS)
The OS was defined as the duration from the date of random assignment to the date of death from any cause or censored at the date of the last follow-up.
Measured: 2 years
Distant Metastasis-Free Survival (DMFS)
The DMFS is evaluated and calculated from the date of random assignment until the day of first distant metastases or until the date of the last follow-up visit.
Measured: 2 years
Progression-Free Survival (PFS)
The PFS was defined as the duration from the date of random assignment to the date of disease progression or censored at the date of the last follow-up.
Measured: 2 years
Score of QLQ-C30
Score of survival quality according to the EORTC Quality of Life Questionnaire (QLQ-C30) before treatment, during treatment, after treatment and follow up.
Measured: 2 years
Score of H&N 35
Score of survival quality according to the EORTC Quality of Life Questionnaire (QLQ-C30 and H\&N 35) before treatment, during treatment, after treatment and follow up.
Measured: 2 years
Incidence of acute postoperative complications
The incidence of acute postoperative complications.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2024
- Study start1 Nov 2023
- Primary completion1 Nov 2028 (estimated)
- Study completion1 Nov 2028 (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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 86 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ming-Yuan Chen
- Sponsor type
- University, hospital or other
- Collaborators
- Fifth Affiliated Hospital, Sun Yat-Sen University, Sun Yat-Sen University Cancer Center, Fifth Affiliated Hospital of Guangzhou Medical University, Huazhong University of Science and Technology Union Shenzhen Hospital, Nanfang Hospital, Southern Medical University, First Affiliated Hospital, Sun Yat-Sen University, First People's Hospital of Foshan, Zhongshan People's Hospital, Guangdong, China
- Responsible party
- Sponsor-investigator, Ming-Yuan Chen, Sun Yat-sen University
- Investigators
- Ming-Yuan Chen, MD,PhD, Principal investigator, SUN yet-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06688760
- Sponsor's protocol ID
- SYSUCC-CMY-2024-02-25
- Status last verified
- Jul 2024
- First submitted
- 25 Jul 2024
- Last updated
- 14 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endoscopic Nasopharyngectomy Combined with Retropharyngeal Lymph Node Dissection Plus Low-dose Radiotherapy Versus Bilateral Upper Neck Dissection for Newly Diagnosed Stage I Nasopharyngeal Carcinoma: a Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT06688760
- Acronym / sponsor ID
- SYSUCC-CMY-2024-02-25
- Conditions
- Nasopharyngeal Carcinoma, Surgery, Radiotherapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 86 participants (estimated)
- Lead sponsor
- Ming-Yuan ChenUniversity, hospital or other
- Collaborators
- Fifth Affiliated Hospital, Sun Yat-Sen University, Sun Yat-Sen University Cancer Center, Fifth Affiliated Hospital of Guangzhou Medical University, Huazhong University of Science and Technology Union Shenzhen Hospital, Nanfang Hospital, Southern Medical University, First Affiliated Hospital, Sun Yat-Sen University, First People's Hospital of Foshan, Zhongshan People's Hospital, Guangdong, China
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 1 Nov 2028 (estimated)
- Study completion
- 1 Nov 2028 (estimated)
- First posted
- 14 Nov 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.
The goal of this clinical trial is to compare the efficacy and safety of endoscopic nasopharyngectomy combined with retropharyngeal lymph nodes dissection plus bilateral upper neck lymph node dissection or plus postoperative low-dose radiotherapy in newly diagnosed stage Ⅰ nasopharyngeal carcinoma.
Detailed description
At present, the newly diagnosed non metastatic nasopharyngeal carcinoma has achieved good therapeutic effect under the treatment scheme of intensity modulated radiotherapy. The 5-year survival rate of the newly diagnosed stage Ⅰ nasopharyngeal carcinoma was more than 95%. But at the same time, all patients receiving radical radiotherapy will experience different degrees of acute or chronic radiation injury, which will affect the quality of life of patients to varying degrees. For stage Ⅰ nasopharyngeal carcinoma with the primary lesion confined to the nasopharyngeal mucosa and without regional lymph node metastasis, in theory, the primary lesion can be removed by minimally invasive surgery without preventive treatment of cervical lymph nodes.
Our previous research results showed that endoscopic surgery could achieved similar survival outcomes but less adverse events than radiotherapy for Stage Ⅰ nasopharyngeal carcinoma with short diameter of retropharyngeal lymph nodes<0.4cm or short diameter of cervical lymph nodes<0.6 and negative PET/CT findings. However, if there is the same results for all stage I NPC patients is still unclear. Therefore, this study aims to compare the efficacy and safety of endoscopic nasopharyngectomy combined with retropharyngeal lymph node dissection combined with low-dose radiotherapy or bilateral upper neck lymph node dissection compared with conventional intensity-modulated radiotherapy.
When the patients participated in this study, the stage ⅠNPC patient of experimental group 1 received endoscopic nasopharyngectomy combined with retropharyngeal lymph node dissection and low-dose radiotherapy. Low dose radiotherapy target area: CTV1 (tumor bed area); For the primary lesion with negative margin but less than 3mm, the margin area should be included; For patients with extracapsular invasion of lymph nodes, the extracapsular invasion area should be included; It should also include all cervical lymph nodes located above the cricoid cartilage detected by CT/MRI, regardless of size; CTV2: low risk infiltration area. The prescription dose of intensity modulated radiotherapy: CTV1:36.00gy/15fr/2.40gy; CTV2:30.00gy/15fr/2.00gy. The patients in the stage Ⅰ in the experimental group 2 underwent endoscopic nasopharynx resection combined with retropharyngeal lymph node resection and bilateral upper neck lymph node dissection, without radiotherapy or chemotherapy after surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Surgery plus low dose radiotherapy | Experimental | Procedure: Endoscopic nasopharyngectomy combine Retropharyngeal lymphadenectomy and Low Dose RadiotherapySurgery: Endoscopic Nasopharyngectomy: Radical resection of primary lesion using nasal endoscopy. Retropharyngeal Lymphadenectomy: Radical retropharyngeal LNs resection using nasal endoscopy. Radiotherapy: Low Dose Raiotherapy: Low dose radiotherapy target area: CTV1: tumor bed area; For cases where the margin of the primary lesion is negative but less than 3mm, the margin area should be included; It should also include all cervical lymph nodes located above the cricoid cartilage detected by CT/MRI, regardless of size; CTV2: Low risk infiltration area. Intensity modulated radiation therapy prescription dose: CTV1: 36.00Gy/15Fr/2.40Gy; CTV2: 30.00Gy/15Fr/2.00Gy. |
| Surgery | Experimental | Procedure: Endoscopic nasopharyngectomy combine Retropharyngeal lymphadenectomy and Low Dose Radiotherapy, Procedure: Endoscopic nasopharyngectomy combine Retropharyngeal lymphadenectomy and Double upper neck lymph node dissectionEndoscopic Nasopharyngectomy: Radical resection of primary lesion using nasal endoscopy. Retropharyngeal Lymphadenectomy: Radical retropharyngeal LNs resection using nasal endoscopy. Bilateral Upper Neck Lymph Node Dissection: the specific cleaning area is the lymph nodes upon the Hyoid bone regions. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Performance Status Score 0-1 points.
- Non-keratinized carcinoma of the nasopharynx (differentiated or undifferentiated, i.e., WHO type II or III) confirmed histologically and/or cytologically.
- According to the UICC/AJCC eighth edition staging, the patient is defined as T1N0M0 stage I.
- Adequate organ function: WBC ≥ 4×10^9 /L, NEUT ≥ 2×10^6 /L, HGB ≥ 9 g/dL, PLT count ≥ 100×10^9/L, TBIL ≤1.5 ULN, ALT ≤3 ULN, AST ≤3 ULN, ALP ≤3 ULN, ALB ≥ 3 g/dL, INR or APTT≤1.5 ULN, Scr ≤1.5 ULN or Ccr ≥ 60 mL/min.
- Informed Concent signed with willingness to obey the follow-up, treatment, examination and any other programs according to the research protocol.
Key exclusion criteria (5 listed)
- Diagnosed as recurrent or distant metastatic nasopharyngeal carcinoma or together with any other malignancy.
- Suffering severe organ dysfunction or physical disorder which could not tolerate surgery or radiotherapy.
- Unable to cooperate with regular follow-up due to psychological, social, domestic or geological reasons.
- During pregnancy or lactation.
- Other patients that the chief physician considered as illegal for this trial.
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 |
|---|---|---|
| Endoscopic nasopharyngectomy combine Retropharyngeal lymphadenectomy and Low Dose Radiotherapyin experimental arm 1 | Procedure or surgery | Surgery, Surgery plus low dose radiotherapy |
| Endoscopic nasopharyngectomy combine Retropharyngeal lymphadenectomy and Double upper neck lymph node dissectionin experimental arm 2 | Procedure or surgery | Surgery |
Primary outcome
Local Regional Relapse-Free Survival (LRRFS)
Time frame: 2 years
The LRRFS is evaluated and calculated from the date of random assignment until the day of first local regional relapse or until the date of the last follow-up visit.
7 secondary outcomes
The incidence of serious complications
Time frame: 2 years
Overall Survival (OS)
Time frame: 2 years
Distant Metastasis-Free Survival (DMFS)
Time frame: 2 years
Progression-Free Survival (PFS)
Time frame: 2 years
Score of QLQ-C30
Time frame: 2 years
Score of H&N 35
Time frame: 2 years
Incidence of acute postoperative complications
Time frame: 2 weeks
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 14 Nov 2024.
- 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.
Ming-Yuan Chen, MD,PhD principal investigator
SUN yet-sen University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endoscopic nasopharyngectomy combine Retropharyngeal lymphadenectomy and Low Dose Radiotherapy and Endoscopic nasopharyngectomy combine Retropharyngeal lymphadenectomy and Double upper neck lymph node dissection in people with Nasopharyngeal Carcinoma and Surgery, run by Ming-Yuan Chen at 2 sites 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 5 inclusion and 5 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 14 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 Ming-Yuan Chen, MD,PhD (+8613903052650, chmingy@email.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Local Regional Relapse-Free Survival (LRRFS) (time frame: 2 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 14 Nov 2024; AzTrials last refreshed its copy on 7 Nov 2026.