Clinical trial · Interventional
To Study the Feasibility and Quality of Life of Medial Group Retropharyngeal Node Sparing in Nasopharyngeal Carcinoma
Prospective Randomised Controlled Non-inferior Trial Studying the Feasibility and Potential Quality of Life Benefits of Medial Group Retropharyngeal Node Sparing in Nasopharyngeal Carcinoma
NCT03346109CI-TRIAL-00057613unknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is an randomized, controlled, phase 3 clinical trial. The purpose of this study is to evaluate whether medial group retropharyngeal node (MRLN) sparing could reduce the incidence of radiation-caused dysphagia and improve patients' quality of life without compromising survival rate.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Nasopharyngeal Carcinoma | Nasopharyngeal Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| medial group retropharyngeal node(MRLN) sparing | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- MRLN sparing group
- description
- Patients in medial group retropharyngeal node(MRLN) sparing group will not routinely receive MRLN irradiation to 56Gy/33Fr
- interventionNames
- Radiation: medial group retropharyngeal node(MRLN) sparing
- type
- NO_INTERVENTION
- label
- MRLN prophylactic irradiation group
- description
- Patients in MRLN prophylactic irradiation group will always receive MRLN irradiation to 56Gy/33Fr
Primary outcomes (1)
- measure
- Local replase-free survival rate
- timeFrame
- 3 Year
- description
- Local failure-free survival is calculated from randomization to the first local failure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients without medial group retropharyngeal node metastasis; 2. Patients with newly histologically confirmed non-keratinizing (according to WHO histologically type); 3. Tumor staged as T1-4N0-3(according to the 8th AJCC edition); 4. No evidence of distant metastasis (M0); 5. Satisfactory performance status: Karnofsky scale (KPS) ≥ 70; 6. Patients must be informed of the investigational nature of this study and give written informed consent. Exclusion Criteria: 1. Patients with medial group retropharyngeal node metastasis; 2. Aged \> 65 or \< 18; 3. Treatment with palliative intent; 4. Prior malignancy except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer; 5. Pregnancy or lactation (consider pregnancy test in women of child-bearing age and emphasize effective contraception during the treatment period); 6. With history of previous RT (except for non-melanomatous skin cancers outside intended RT treatment volume); 7. Prior chemotherapy or surgery (except diagnostic) to primary tumor or nodes; 8. Any severe intercurrent disease, which may bring unacceptable risk or affect the compliance of the trial.
References
Publications (2)
- DERIVEDWang SX, Tao YL, Gao TS, Zhang N, Zhou GQ, Xie FY, Zhang Y, Guo R, Yang Y, Li YJ, Liang SQ, Zeng YC, Lin L, Li WF, Liu X, Xu C, Chen YP, Lv JW, Liu LZ, Li HJ, Li JB, Wen HM, Sun Y, Tang LL, Liang XY, Ma J, Mao YP. Medial retropharyngeal nodal region sparing radiotherapy in nasopharyngeal carcinoma: five year analysis of open label, non-inferiority, multicentre, randomised phase 3 trial. BMJ. 2026 Mar 31;392:e086050. doi: 10.1136/bmj-2025-086050. PMID 41916649
- DERIVEDMao YP, Wang SX, Gao TS, Zhang N, Liang XY, Xie FY, Zhang Y, Zhou GQ, Guo R, Luo WJ, Li YJ, Liang SQ, Lin L, Li WF, Liu X, Xu C, Chen YP, Lv JW, Huang SH, Liu LZ, Li JB, Tang LL, Chen L, Sun Y, Ma J. Medial retropharyngeal nodal region sparing radiotherapy versus standard radiotherapy in patients with nasopharyngeal carcinoma: open label, non-inferiority, multicentre, randomised, phase 3 trial. BMJ. 2023 Feb 6;380:e072133. doi: 10.1136/bmj-2022-072133. PMID 36746459