Individualized Elective Neck Irradiation in NPC Patients
Individualized Elective Neck Irradiation Based on the Lymph Node Metastasis Pattern in NPC Patients
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Estimated)
Phase
- Phase 3
Contacts and Locations
Study Contact
- Name: Ling-Long Tang, Prof
- Phone Number: 02087343840
- Email: tangll@sysucc.org.cn
Study Locations
-
-
Guangdong
-
Guangzhou, Guangdong, China, 510060
- Recruiting
- Sun Yat-sen University Cancer Center
-
Contact:
- Ling-Long Tang, Prof
- Phone Number: 02087343840
- Email: tangll@sysucc.org.cn
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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-neck 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Standard group
Upper-neck irradiation at the uninvolved neck
|
Individualized Elective Neck Irradiation
|
|
Experimental: Experimental group
The low-risk clinical target volume would be reduced to two vertebral levels below the vertebral level of the metastatic level II-V nodes.
|
Individualized Elective Neck Irradiation
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Regional relapse-free survival
Time Frame: 3 years
|
The regional relapse-free survival rate will be estimated using Kaplan-Meier method for each arm from the date of randomization to the date of nodal relapse or death from any cause, whichever occurred first.
Their differences will be compared between treatment arms using the log-rank test.
|
3 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Radiation-related toxicity
Time Frame: Within 3 month after radiotherapy for acute toxicity; long term for late toxicity
|
Acute and late toxicity will be documented according to RTOG/EORTC System and the CTCAE(Common Terminology Criteria for Adverse Events).
Toxicity will be summarized using descriptive statistics.
|
Within 3 month after radiotherapy for acute toxicity; long term for late toxicity
|
|
Overall survival
Time Frame: 3 years
|
The overall survival rate will be estimated using Kaplan-Meier method for each arm from the date of randomization to death from any cause.
Their differences will be compared between treatment arms using the log-rank test.
|
3 years
|
|
Local relapse-free survival
Time Frame: 3 years
|
The local relapse-free survival rate will be estimated using Kaplan-Meier method for each arm from the date of randomization to documented local relapse or death from any cause.
Their differences will be compared between treatment arms using the log-rank test.
|
3 years
|
|
Distant metastasis-free survival
Time Frame: 3 years
|
The distant metastasis-free survival rate will be estimated using Kaplan-Meier method for each arm from the date of randomization to documented distant metastasis or death from any cause.
Their differences will be compared between treatment arms using the log-rank test.
|
3 years
|
|
Patient's quality-of-life: global health status
Time Frame: 3 years
|
European Organization for Research and Treatment of Cancer Quality-of-Life Core 30 items (QLQ-C30) version 1.0 questionnaires will be used to assess quality-of-life.
All items pointing to this domain are averaged and then transformed to a scale of 0-100 according to the EORTC scoring manual.
Higher scores on global health status suggest better health.
|
3 years
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Stomatognathic Diseases
- Neoplasms by Site
- Neoplasms
- Neoplasms by Histologic Type
- Head and Neck Neoplasms
- Neoplasms, Glandular and Epithelial
- Carcinoma
- Otorhinolaryngologic Diseases
- Pharyngeal Neoplasms
- Otorhinolaryngologic Neoplasms
- Nasopharyngeal Diseases
- Pharyngeal Diseases
- Nasopharyngeal Neoplasms
- Nasopharyngeal Carcinoma
Other Study ID Numbers
- B2023-651-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.