Nasopharyngeal CarcinomaNCT06533267
Endoscopic Surgery vs. Intensity Modulated Radiotherapy for Stage I Nasopharyngeal Carcinoma.
A study testing Endoscopic nasopharyngectomy followed close follow-up and Intensity-modulated Radiotherapy in people with Nasopharyngeal Carcinoma and Intensity Modulated Radiotherapy, run by Sun Yat-sen University at 1 site in China.
Trial summary
The goal of this clinical trial is to compare the survival and adverse reactions differences between endoscopic surgery and intensity modulated radiotherapy for patients with newly diagnosed stage Ⅰ nasopharyngeal carcinoma, aiming to verifying the efficacy and safety of endoscopic surgery for stage Ⅰ nasopharyngeal… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Nasopharyngeal Carcinoma, Intensity Modulated Radiotherapy, Surgery
- What is being tested?
- Endoscopic nasopharyngectomy followed close follow-up and Intensity-modulated Radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 442 participants
- Where
- 1 siteChina
- Study dates
- 25 Mar 2024to 25 Mar 2034
- 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
- Karnofsky score >70.
- Non-keratinized carcinoma of the nasopharynx (differentiated or undifferentiated, i.e., WHO type II or III) or carcinoma in situ confirmed histologically and/or cytologically.
- According to the eighth edition of UICC/AJCC staging, the patient was defined as T1N0M0 stage I.
- The maximum short diameters of retropharyngeal lymph nodes and cervical lymph nodes were not more than 0.4cm and 0.6cm respectively, or retropharyngeal lymph nodes and cervical lymph nodes were 0.4-0.5cm and 0.6-1.0cm respectively but PET/CT showed negative.
- Informed Concent signed with willingness to obey the follow-up, treatment, examination and any other programs according to the research protocol.
Who cannot join
- MRI showed that the primary tumor diameter >1.5cm, or internal carotid artery vascular malformation which would seriously affect the operation.
- 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 operation or radiotherapy.
- Unable to cooperate with regular follow-up due to psychological, social, domestic or geological reasons.
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 Fifth Affiliated Hospital of Sun Yat-sen University
Zhuhai, Guangdong, 519000
Youping Liu, MD, +8613751763276, liuyp78@email.sysu.edu.cn
About this study
Official title: Endoscopic Surgery Compared With Intensity Modulated Radiotherapy for Stage I Nasopharyngeal Carcinoma : A Multicenter, Randomized Controlled Clinical Trial.
The goal of this clinical trial is to compare the survival and adverse reactions differences between endoscopic surgery and intensity modulated radiotherapy for patients with newly diagnosed stage Ⅰ nasopharyngeal carcinoma, aiming to verifying the efficacy and safety of endoscopic surgery for stage Ⅰ nasopharyngeal carcinoma.
Read the detailed description
The newly diagnosed non-metastatic nasopharyngeal carcinoma has shown satisfactory therapeutic effect under the intensity modulated radiation. The 5-year survival rate of the newly diagnosed Ⅰ nasopharyngeal carcinoma was more than 95%. However, mos 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 primary lesion confined to nasopharyngeal mucosa and without regional lymph node metastasis, in theory, the primary lesion can be removed by minimally invasive surgery without need of preventive treatment of cervical lymph nodes according to the prior study.
Based on our previous research results, we stratified the nasopharyngeal primary tumor diameter of stage Ⅰ nasopharyngeal carcinoma by whether the short diameter of retropharyngeal lymph nodes and neck lymph nodes was smaller than 0.4cm and 0.6cm respectively, and the tumor diameter of nasopharyngeal primary tumor was ≤ 1.5cm. This study evaluated the efficacy and safety of endoscopic minimally invasive surgery compared to conventional intensity-modulated radiotherapy for these stage Ⅰ nasopharyngeal carcinoma.
In this study, the stage Ⅰ patients in the experimental group only received endoscopic nasopharynx resection and were followed up closely to monitor the recurrence and distant metastasis of the tumor.
The patients in the control group received conventional intensity-modulated radiotherapy and regular follow-up. The target area and dose of radiotherapy were as follows: GTVnx: primary lesion of the nasopharynx; CTV1: high-risk area and the entire nasopharynx; CTV2: low-risk area. The recommended intensity-modulated radiotherapy dose is GTVnx(69.96 Gy/33 Fr/2.12 Gy); CTV1(60.60 Gy/33 Fr/1.82 Gy); CTV2(54.12 Gy/33 Fr/1.64 Gy).
- Being tested
- Endoscopic nasopharyngectomy followed close follow-up, Intensity-modulated 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.
Endoscopic nasopharyngectomy followed close follow-upProcedure or surgery
Radical resection of primary lesion using nasal endoscopy.
After the treatment, the electronic nasal endoscopy was reviewed every two weeks to determine the healing of the wound, whether there was tumor recurrence, until the surgical wound was completely healed. The patients were followed up at least once every three months from the first year to the third year, at least once every six months from the fourth year to the fifth year, and at least once every year after five years.
Intensity-modulated RadiotherapyRadiation
GTVnx (nasopharyngeal lesions): 69.96Gy/33Fr/2.12Gy CTV1: 60.60Gy/33Fr/1.82Gy CTV2: 54.12Gy/33Fr/1.64Gy.
After treatment, patients were followed up every 3-6 months from the first year to the third year, every 6-12 months from the fourth year to the fifth year, and at least once a year after five years.
| Study group | Role | What they receive |
|---|---|---|
| Surgery plus close follow-up | Experimental | Surgery:
Endoscopic Nasopharyngectomy: Radical resection of the primary lesion using nasal endoscopy. Receives: Procedure: Endoscopic nasopharyngectomy followed close follow-up |
| Intensity modulated radiotherapy | Active comparator | Radiotherapy:
Intensity-modulated Radiotherapy:
GTVnx: 69.96Gy/33Fr/2.12Gy CTV1: 59.4Gy/33Fr/1.8Gy CTV2: 54.12Gy/33Fr/1.64Gy Receives: Radiation: Intensity-modulated Radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival (OS)
Defined as the time interval from randomization to death due to any cause.
Measured: 5 years
Incidence of ≥3 grade adverse events
The proportion of patients with ≥3 grade adverse events according to CTCAE 5.0/RTOG criteria.
Measured: 5 years
Secondary outcomes (7)
Local Regional Relapse-Free Survival (LRRFS)
Defined as the time from randomisation to the date of first locoregional relapse.
Measured: 5 years
Distant Metastasis-Free Survival (DMFS)
Defined as the time interval from randomisation to the date of first distant metastases.
Measured: 5 years
Progress-Free Survival (PFS)
Defined as time from randomization to locoregional or distant metastasis relapse or death from any cause, whichever occurred first.
Measured: 5 years
The proportion of patients with treatment related complications
The proportion of patients with treatment related complications according to NCI-CTC5.0 criteria and RTOG criteria.
Measured: 5 years
Objective response rate (ORR)
Objective response rate (ORR) is defined as the proportion of patients with a complete response or partial response to treatment. (according to tumor imaging examinations 3 months after the end of treatment/supplementary treatment)
Measured: 3 months
Score of survival quality according to the EORTC Quality of Life Questionnaire (QLQ)-C30 (V3.0)
Score of survival quality according to the EORTC Quality of Life Questionnaire (QLQ)-C30 (V3.0) before treatment, during treatment, after treatment.
Measured: 5 years
Score of survival quality according to the EORTC Quality of Life Questionnaire Head and Neck (The QLQ-H&N35)
Score of survival quality according to the EORTC Quality of Life Questionnaire Head and Neck (The QLQ-H\&N35) before treatment, during treatment, after treatment.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2024
- Study start25 Mar 2024
- Primary completion25 Mar 2034 (estimated)
- Study completion25 Mar 2034 (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 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
- 442 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Collaborators
- Fifth Affiliated Hospital, Sun Yat-Sen University, Fifth Affiliated Hospital of Guangzhou Medical University, Huazhong University of Science and Technology Union Shenzhen Hospital, First Affiliated Hospital, Sun Yat-Sen University, Nanfang Hospital, Southern Medical University, First People's Hospital of Foshan, Zhongshan People's Hospital, Guangdong, China
- Responsible party
- Principal investigator, Ming-Yuan Chen, Sun Yat-sen University
- Investigators
- Ming-Yuan Chen, MD,PhD, Principal investigator, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06533267
- Sponsor's protocol ID
- SYSUCC-CMY-2024-02-24
- Status last verified
- Jul 2024
- First submitted
- 24 Jul 2024
- Last updated
- 1 Aug 2024
- 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 1 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endoscopic Surgery Compared With Intensity Modulated Radiotherapy for Stage I Nasopharyngeal Carcinoma : A Multicenter, Randomized Controlled Clinical Trial.
- ClinicalTrials.gov ID
- NCT06533267
- Acronym / sponsor ID
- SYSUCC-CMY-2024-02-24
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 442 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Collaborators
- Fifth Affiliated Hospital, Sun Yat-Sen University, Fifth Affiliated Hospital of Guangzhou Medical University, Huazhong University of Science and Technology Union Shenzhen Hospital, First Affiliated Hospital, Sun Yat-Sen University, Nanfang Hospital, Southern Medical University, First People's Hospital of Foshan, Zhongshan People's Hospital, Guangdong, China
- Study start
- 25 Mar 2024 (actual)
- Primary completion
- 25 Mar 2034 (estimated)
- Study completion
- 25 Mar 2034 (estimated)
- First posted
- 1 Aug 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 survival and adverse reactions differences between endoscopic surgery and intensity modulated radiotherapy for patients with newly diagnosed stage Ⅰ nasopharyngeal carcinoma, aiming to verifying the efficacy and safety of endoscopic surgery for stage Ⅰ nasopharyngeal carcinoma.
Detailed description
The newly diagnosed non-metastatic nasopharyngeal carcinoma has shown satisfactory therapeutic effect under the intensity modulated radiation. The 5-year survival rate of the newly diagnosed Ⅰ nasopharyngeal carcinoma was more than 95%. However, mos 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 primary lesion confined to nasopharyngeal mucosa and without regional lymph node metastasis, in theory, the primary lesion can be removed by minimally invasive surgery without need of preventive treatment of cervical lymph nodes according to the prior study.
Based on our previous research results, we stratified the nasopharyngeal primary tumor diameter of stage Ⅰ nasopharyngeal carcinoma by whether the short diameter of retropharyngeal lymph nodes and neck lymph nodes was smaller than 0.4cm and 0.6cm respectively, and the tumor diameter of nasopharyngeal primary tumor was ≤ 1.5cm. This study evaluated the efficacy and safety of endoscopic minimally invasive surgery compared to conventional intensity-modulated radiotherapy for these stage Ⅰ nasopharyngeal carcinoma.
In this study, the stage Ⅰ patients in the experimental group only received endoscopic nasopharynx resection and were followed up closely to monitor the recurrence and distant metastasis of the tumor.
The patients in the control group received conventional intensity-modulated radiotherapy and regular follow-up. The target area and dose of radiotherapy were as follows: GTVnx: primary lesion of the nasopharynx; CTV1: high-risk area and the entire nasopharynx; CTV2: low-risk area. The recommended intensity-modulated radiotherapy dose is GTVnx(69.96 Gy/33 Fr/2.12 Gy); CTV1(60.60 Gy/33 Fr/1.82 Gy); CTV2(54.12 Gy/33 Fr/1.64 Gy).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Surgery plus close follow-up | Experimental | Procedure: Endoscopic nasopharyngectomy followed close follow-upSurgery: Endoscopic Nasopharyngectomy: Radical resection of the primary lesion using nasal endoscopy. |
| Intensity modulated radiotherapy | Active comparator | Radiation: Intensity-modulated RadiotherapyRadiotherapy: Intensity-modulated Radiotherapy: GTVnx: 69.96Gy/33Fr/2.12Gy CTV1: 59.4Gy/33Fr/1.8Gy CTV2: 54.12Gy/33Fr/1.64Gy |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Karnofsky score >70.
- Non-keratinized carcinoma of the nasopharynx (differentiated or undifferentiated, i.e., WHO type II or III) or carcinoma in situ confirmed histologically and/or cytologically.
- According to the eighth edition of UICC/AJCC staging, the patient was defined as T1N0M0 stage I.
- The maximum short diameters of retropharyngeal lymph nodes and cervical lymph nodes were not more than 0.4cm and 0.6cm respectively, or retropharyngeal lymph nodes and cervical lymph nodes were 0.4-0.5cm and 0.6-1.0cm respectively but PET/CT showed negative.
- Informed Concent signed with willingness to obey the follow-up, treatment, examination and any other programs according to the research protocol.
Key exclusion criteria (4 listed)
- MRI showed that the primary tumor diameter >1.5cm, or internal carotid artery vascular malformation which would seriously affect the operation.
- 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 operation or radiotherapy.
- Unable to cooperate with regular follow-up due to psychological, social, domestic or geological reasons.
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 followed close follow-upRadical resection of primary lesion using nasal endoscopy. After the treatment, the electronic nasal endoscopy was reviewed every two weeks to determine the healing of the wound, whether there was tumor recurrence, until the surgical wound was completely healed. The patients were followed up at least once every three months from the first year to the third year, at least once every six months from the fourth year to the fifth year, and at least once every year after five years. | Procedure or surgery | Surgery plus close follow-up |
| Intensity-modulated RadiotherapyGTVnx (nasopharyngeal lesions): 69.96Gy/33Fr/2.12Gy CTV1: 60.60Gy/33Fr/1.82Gy CTV2: 54.12Gy/33Fr/1.64Gy. After treatment, patients were followed up every 3-6 months from the first year to the third year, every 6-12 months from the fourth year to the fifth year, and at least once a year after five years. | Radiation | Intensity modulated radiotherapy |
Primary outcome
Overall Survival (OS)
Time frame: 5 years
Defined as the time interval from randomization to death due to any cause.
Incidence of ≥3 grade adverse events
Time frame: 5 years
The proportion of patients with ≥3 grade adverse events according to CTCAE 5.0/RTOG criteria.
7 secondary outcomes
Local Regional Relapse-Free Survival (LRRFS)
Time frame: 5 years
Distant Metastasis-Free Survival (DMFS)
Time frame: 5 years
Progress-Free Survival (PFS)
Time frame: 5 years
The proportion of patients with treatment related complications
Time frame: 5 years
Objective response rate (ORR)
Time frame: 3 months
Score of survival quality according to the EORTC Quality of Life Questionnaire (QLQ)-C30 (V3.0)
Time frame: 5 years
Score of survival quality according to the EORTC Quality of Life Questionnaire Head and Neck (The QLQ-H&N35)
Time frame: 5 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 1 Aug 2024.
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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 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 Endoscopic nasopharyngectomy followed close follow-up and Intensity-modulated Radiotherapy in people with Nasopharyngeal Carcinoma and Intensity Modulated Radiotherapy, 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 5 inclusion and 4 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 1 Aug 2024. 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 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?
Overall Survival (OS) (time frame: 5 years). The study lists 2 primary outcomes in all. 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 1 Aug 2024.