Trial Title:
Reduced Volume of Neck Prophylactic Irradiation in Nasopharyngeal Carcinoma
NCT ID:
NCT05780372
Condition:
Nasopharyngeal Carcinoma
Radiotherapy; Complications
Conditions: Official terms:
Carcinoma
Nasopharyngeal Carcinoma
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Radiation
Intervention name:
Intensity Modulated Radiation Therapy
Description:
All target volumes will be outlined slice by slice on the axial contrast-enhanced CT with
MR fusion images in the treatment planning system. The target volumes are defined in
accordance with the International Commission on Radiation Units and Measurements Reports
83. The prescribed dose is 70-72 Gy to PTVp (Planning target volume of the primary
tumor), 64-70 Gy to PTVn (Planning target volume of the lymph node),60- 64Gy to PTV1
(High-risk planning target volume), and 54-58 Gy to PTV2 (Low-risk planning target
volume) in 30-32 fractions. The details of dose limits for organs at risk are based on
the study 0225 from The Radiation Therapy Oncology Group (RTOG 0225).
Arm group label:
Conventional CTVn2
Arm group label:
Reduced CTVn2
Other name:
IMRT
Intervention type:
Drug
Intervention name:
Chemotherapy
Description:
Chemotherapy will be arranged by the physician-in-charge according to the NCCN guideline,
patient's stage and physical condition.
Arm group label:
Conventional CTVn2
Arm group label:
Reduced CTVn2
Summary:
This is a multi-center, non-inferiority, open-label, randomized controlled phase III
clinical trial in primary diagnosed nasopharyngeal carcinoma (NPC) patients without
distant metastasis. The purpose of this study is to evaluate the efficacy of reduced neck
prophylactic radiotherapy versus conventional neck prophylactic radiotherapy, and compare
the radiotherapy-related adverse events and quality of life in two groups.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Newly histologic diagnosis of nasopharyngeal non-keratinizing carcinoma (WHO
II/III);
- All genders, range from 18-70 years old;
- ECOG score 0-1;
- Clinical stage I-IVa (AJCC/UICC 8th);
- Not received radiotherapy, chemotherapy and other anti-tumor treatment (including
immunotherapy);
- No contraindications to chemotherapy or radiotherapy;
- Adequate organ function: white blood cell count ≥ 4×109/L, neutrophile granulocyte
count ≥ 1.5×109/L, hemoglobin ≥ 9g/L, platelet count ≥ 100×109/L; alanine
aminotransferase or aspartate aminotransferase < 2.5×upper limit of normal; blood
urea nitrogen or creatinine ≤ 1.5×upper limit of normal or endogenous creatinine
clearance ≥ 60ml/min (Cockcroft-Gault formula);
- Sign the consent form.
Exclusion Criteria:
- Neck lymph nodes exist skipping metastasis;
- Distant metastases;
- Keratinized squamous cell carcinoma or basal cell like squamous cell carcinoma;
- Have or are suffering from other malignant tumors;
- Participating in other clinical trials;
- Pregnancy or lactation;
- Have uncontrolled cardiovascular disease;
- Severe complication, eg, uncontrolled hypertension;
- Mental disorder;
- Drug or alcohol addition;
- Do not have full capacity for civil acts.
Gender:
All
Minimum age:
18 Years
Maximum age:
70 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Chongqing Cancer Hospital
Address:
City:
Chongqing
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Ying Wang, MD
Facility:
Name:
Dongguan People Hospital
Address:
City:
Dongguan
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Zhigang Liu, MD, PhD
Facility:
Name:
Sun Yat-sen University Cancer Center
Address:
City:
Guangzhou
Zip:
510060
Country:
China
Status:
Recruiting
Contact:
Last name:
Chong Zhao, MD, PhD
Email:
zhaochong@sysucc.org.cn
Facility:
Name:
Liuzhou Worker's Hospital
Address:
City:
Liuzhou
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Ying Lu, MD
Facility:
Name:
The First Affiliated Hospital of Guangxi Medical University
Address:
City:
Nanning
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Rensheng Wang, MD
Facility:
Name:
Jiangxi Cancer Hospital of Nanchang University
Address:
City:
Nanchang
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Jingao Li, MD, PhD
Facility:
Name:
Zhejiang Cancer Hospital
Address:
City:
Hangzhou
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Xiaozhong Chen, MD, PhD
Start date:
August 8, 2023
Completion date:
August 2029
Lead sponsor:
Agency:
Sun Yat-sen University
Agency class:
Other
Collaborator:
Agency:
Jiangxi Provincial Cancer Hospital
Agency class:
Other
Collaborator:
Agency:
Zhejiang Cancer Hospital
Agency class:
Other
Collaborator:
Agency:
Chongqing University Cancer Hospital
Agency class:
Other
Collaborator:
Agency:
Dongguan People's Hospital
Agency class:
Other
Collaborator:
Agency:
LiuZhou People's Hospital
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/NCT05780372
http://www.sysucc.org.cn
