To hear about similar clinical trials, please enter your email below
Trial Title:
Endoscopic Surgery vs. Intensity Modulated Radiotherapy for Stage I Nasopharyngeal Carcinoma.
NCT ID:
NCT06533267
Condition:
Nasopharyngeal Carcinoma
Intensity Modulated Radiotherapy
Surgery
Conditions: Official terms:
Carcinoma
Nasopharyngeal Carcinoma
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
Endoscopic nasopharyngectomy followed close follow-up
Description:
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.
Arm group label:
Surgery plus close follow-up
Intervention type:
Radiation
Intervention name:
Intensity-modulated Radiotherapy
Description:
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.
Arm group label:
Intensity modulated radiotherapy
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 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).
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
The Fifth Affiliated Hospital of Sun Yat-sen University
Address:
City:
Zhuhai
Zip:
519000
Country:
China
Status:
Recruiting
Contact:
Last name:
Youping Liu, MD
Phone:
+8613751763276
Email:
liuyp78@email.sysu.edu.cn
Start date:
March 25, 2024
Completion date:
March 25, 2034
Lead sponsor:
Agency:
Sun Yat-sen University
Agency class:
Other
Collaborator:
Agency:
Fifth Affiliated Hospital, Sun Yat-Sen University
Agency class:
Other
Collaborator:
Agency:
Fifth Affiliated Hospital of Guangzhou Medical University
Agency class:
Other
Collaborator:
Agency:
Huazhong University of Science and Technology Union ShenZhen Hospital (Nanshan Hospital)
Agency class:
Other
Collaborator:
Agency:
First Affiliated Hospital, Sun Yat-Sen University
Agency class:
Other
Collaborator:
Agency:
Nanfang Hospital, Southern Medical University
Agency class:
Other
Collaborator:
Agency:
First People's Hospital of Foshan
Agency class:
Other
Collaborator:
Agency:
Zhongshan People's Hospital, Guangdong, China
Agency class:
Other
Source:
Sun Yat-sen University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06533267
