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Trial Title:
Individualized Elective Neck Irradiation in NPC Patients
NCT ID:
NCT06241612
Condition:
Nasopharyngeal Carcinoma
Conditions: Official terms:
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:
Individualized Elective Neck Irradiation
Description:
Individualized Elective Neck Irradiation
Arm group label:
Experimental group
Arm group label:
Standard group
Summary:
To evaluate whether individualized elective neck irradiation for nasopharyngeal carcinoma
based on the vertebral level of metastatic lymph nodes can reduce the incidence of
radiation-related adverse effects and improve patients' quality of life，without reducing
survival.
Detailed description:
A multicenter phase III noninferiority randomized trial (NCT02642107) showed that
upper-neck irradiation at the uninvolved neck resulted in comparable regional control and
survival rate to standard whole-neck irradiation in NPC, reduced late toxicity of
hypothyroidism, dysphagia, and neck tissue damage, and improved quality of life,
including fatigue and swallowing.
However, the vertical range of the upper neck is extensive, necessitating further
reduction in the scope of prophylactic irradiation. By integrating MRI and PET-CT to
accurately assess metastatic lymph nodes and their corresponding vertebral levels, the
investigators identified a pattern of sequential lymph node metastasis descending along
the vertebral body in the vertical direction. Further correlative analysis revealed that
nodal metastasis at any one of the vertebral levels strongly and positively correlated
with metastasis at two adjacent vertebral levels, including one level above and one
below.
Considering this, the investigators propose the following scientific hypothesis:
individualized elective neck irradiation for nasopharyngeal carcinoma based on the
vertebral level of metastatic lymph nodes can reduce the incidence of radiation-related
adverse effects and improve patients' quality of life, without reducing survival. The
investigators thus conduct a multicenter randomized phase 3 trial to verify their
hypothesis.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- The eligibility criteria are: newly diagnosed, untreated, non-distant metastatic,
and non-keratinizing NPC; nodes are diagnosed with PET/CT and MRI; staged as
T1-4N0-2 or N3 category of non-bilateral lower node metastasis; aged between 18 and
70 years; Karnofsky performance-status score > 70; adequate haematological function,
with a leucocyte count > 4 × 109/L, haemoglobin > 90 g/L, and a thrombocyte count >
100×109/L
Exclusion Criteria:
- The exclusion criteria include: previous chemotherapy treatment, surgery (except
diagnostic) or radiotherapy to the neck or nasopharyngeal regions; previous
malignancy; lactation or pregnancy; or severe coexisting illness.
Gender:
All
Minimum age:
18 Years
Maximum age:
70 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Sun Yat-sen University Cancer Center
Address:
City:
Guangzhou
Zip:
510060
Country:
China
Status:
Recruiting
Contact:
Last name:
Ling-Long Tang, Prof
Phone:
02087343840
Email:
tangll@sysucc.org.cn
Start date:
April 16, 2024
Completion date:
March 2031
Lead sponsor:
Agency:
Sun Yat-sen University
Agency class:
Other
Collaborator:
Agency:
First People's Hospital of Foshan
Agency class:
Other
Collaborator:
Agency:
Sichuan Cancer Hospital and Research Institute
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/NCT06241612
