Clinical trial · Interventional
Proton Therapy for Recurrent Nasopharyngeal Carcinoma
A Prospective Phase II Clinical Study of Proton Therapy for Recurrent Nasopharyngeal Carcinoma
- 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)
The above studies show that most of the supportive evidence for the reduction of toxicity and improvement of efficacy of proton therapy for recurrent Nasopharyngeal carcinoma(NPC) comes from various observational and retrospective studies, lacking high-level evidence-based medical evidence. The conduct of this study will explore the safety and efficacy of intensity-modulated proton radiotherapy for recurrent NPC and provide more high-quality evidence-based medical evidence for proton therapy of recurrent cancer.
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 |
|---|---|---|---|
| Recurrent Nasopharyngeal Carcinoma | Nasopharyngeal Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Proton radiation therapy | Device | — | UNRESOLVED |
| Proton therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Proton therapy group
- description
- All patients received proton therapy, with a prescribed dose of 60-66 Gy in 30-33 fractions, 5 days per week, for a total of 6-6.5 weeks.
- interventionNames
- Radiation: Proton therapy
- Device: Proton radiation therapy
Primary outcomes (1)
- measure
- Incidence of severe late complications
- timeFrame
- From enrollment to the three-year follow-up period
- description
- The proportion of subjects whose toxicity reaction is level 3 during the clinical trial period. The researchers record AE that appeared during the clinical trial cycle and grade it according to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Secondary outcomes (3)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Non-metastatic squamous cell carcinoma of the nasopharynx with biopsy confirmation, at stage ≥ T2b and/or with positive lymph nodes, (2) Pathological type WHO I-III 2. PS score (according to Eastern Cooperative Oncology Group (ECOG) standard) 0-1. Age ≥ 18 years. 3. Expected survival period ≥ 6 months 4. Before treatment, evaluate the tumor range and size of the patient. 5. Nutritional and general physical condition must be able to tolerate the recommended radiotherapy and chemotherapy. Exclusion Criteria: 1. Evidence of distant metastasis in stage IVc 2. Patients with isolated recurrence of cervical lymph nodes; 3. Patients have participated in other interventional trials for tumors 4. Having suffered from other malignant tumors within 5 years (excluding melanoma skin cancer) or tumors originating from the head and neck region Untreated active infections
References
Publications (0)
Data not yet available