Individualized Elective Neck Irradiation in NPC Patients

Status Recruiting

Clinical Trial 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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

Nasopharyngeal Carcinoma

Clinical Trial Details

NCT number	NCT06241612
Study type	Interventional
Source	Sun Yat-sen University
Contact	Ling-Long Tang, Prof
Phone	02087343840
Email	tangll@sysucc.org.cn
Status	Recruiting
Phase	Phase 3
Start date	April 16, 2024
Completion date	March 2031

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT05979961` - Phase III Trial of Concurrent Chemotherapy Alone in Patients With Low-risk Nasopharyngeal Carcinoma	Phase 3
Active, not recruiting	`NCT04242199` - Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of INCB099280 in Participants With Advanced Solid Tumors	Phase 1
Recruiting	`NCT05415098` - Study of Safety, Pharmacokinetic and Efficacy of APG-5918 in Advanced Solid Tumors or Lymphomas	Phase 1
Recruiting	`NCT06055816` - Gemcitabine Combined With Endostar and Envafolimab in Elderly Patients With Locally Advanced Nasopharyngeal Carcinoma	Phase 2
Recruiting	`NCT05547971` - Development of Intelligent Model for Radioactive Brain Damage of Nasopharyngeal Carcinoma Based on Radio-metabolomics
Not yet recruiting	`NCT05020925` - SHR-1701 in Combination With Famitinib in Patients With Recurrent/Metastatic Nasopharyngeal Carcinoma	Phase 1/Phase 2
Not yet recruiting	`NCT04548271` - Camrelizumab Combined With Apatinib in Patients With PD-1 Antagonists Resistant Recurrent/Metastatic Nasopharyngeal Carcinoma	Phase 2
Not yet recruiting	`NCT04547088` - Camrelizumab Combined With Apatinib in Patients With First-line Platinum-resistant Recurrent/Metastatic Nasopharyngeal Carcinoma	Phase 2
Recruiting	`NCT02795169` - Trail Evaluating Carbon Ion Radiotherapy With Concurrent Chemotherapy for Locally Recurrent Nasopharyngeal Carcinoma	Phase 1/Phase 2
Terminated	`NCT02569788` - Trail Evaluating Carbon Ion Radiotherapy for Locally Recurrent Nasopharyngeal Carcinoma	Phase 1/Phase 2
Terminated	`NCT02801487` - Trial Evaluating Carbon Ion Radiotherapy With Concurrent Chemotherapy for Locally Recurrent Nasopharyngeal Carcinoma	Phase 1/Phase 2
Completed	`NCT02237924` - Endostar Combined With Intensity-modulated Radiotherapy Compare With Chemoradiation for Nasopharyngeal Carcinoma	Phase 2
Recruiting	`NCT02044562` - Dietary Nitrate on Plasma Nitrate Levels for Nasopharyngeal Carcinoma Patients	N/A
Terminated	`NCT01694576` - NPC Staged N2-3M0:Adjuvant Chemotherapy or Just Observation After Concurrent Chemoradiation	Phase 2
Recruiting	`NCT01462903` - A Study of Adoptive Immunotherapy With Autologous Tumor Infiltrating Lymphocytes in Solid Tumors	Phase 1
Completed	`NCT01271439` - Study of Chemoradiotherapy Combined With Cetuximab in Nasopharyngeal Carcinoma	Phase 2
Completed	`NCT00535795` - Phase III: Assess Conventional RT w/ Conventional Plus Accelerated Boost RT in the Treatment of Nasopharyngeal CA	Phase 3
Completed	`NCT00379262` - Therapeutic Gain by Induction-concurrent Chemoradiotherapy and/or Accelerated Fractionation for Nasopharyngeal Carcinoma	Phase 3
Completed	`NCT03398980` - Late Sequelae of Childhood and Adolescent Nasopharyngeal Carcinoma Survivors After Radiotherapy	N/A
Completed	`NCT01309633` - Study Evaluating Two Loading Regimens of Sunitinib or Bevacizumab Alternating With Cisplatin and Gemcitabine as Induction Therapy for Locally Advanced Nasopharyngeal Carcinoma (NPC)	Phase 2