Clinical trial · Interventional
Individualized Carbon-Ion Radiotherapy for Patients With Locally Recurrent Nasopharyngeal Carcinoma
Predictive-Model Based Individualized Carbon-Ion Radiotherapy for Patients With Locally Recurrent Nasopharyngeal Carcinoma: A Phase 2 Randomized Trial
- 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 a randomized phase 2 trial with 2 groups (control group vs experimental group). Patients with locally recurrent nasopharyngeal carcinoma (LR-NPC) assigned to the control group will receive standardized carbon-ion radiotherapy (CIRT). For patients assigned to the experimental group, a predictive model will be used to predict the chance of developing mucosal necrosis after salvage carbon-ion radiotherapy, and individualized dose prescription will be given. The primary endpoint of the study is to compare the 2-year progression-free survival (PFS) between 2 groups.
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 |
|---|---|---|---|
| Locally Recurrent Nasopharyngeal Carcinoma | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Individualized CIRT | Radiation | — | UNRESOLVED |
| Standardized CIRT | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Standardized CIRT
- description
- Patients will receive standardized CIRT with a dose of 63 GyE/21 fx.
- interventionNames
- Radiation: Standardized CIRT
- type
- EXPERIMENTAL
- label
- Individualized CIRT
- description
- A previously predictive model will be used to predict the chance of developing mucosal necrosis after salvage carbon-ion radiotherapy, and individualized dose prescription will be given. A dose of 60 GyE/20 fx, 63 GyE/21 fx and 66 GyE/22 fx will be given to patients with high, moderate and low risk of developing mucosal necrosis, respectively.
- interventionNames
- Radiation: Individualized CIRT
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Aged between 17-70 years. * Pathologically diagnosed as WHO type 2/3 nasopharyngeal carcinoma. * Failed previous definitive radiotherapy at least 6 months ago. * Only had 1 previous course of radiotherapy. * Eastern Cooperative Oncology Group score: 0-1. * Adequate laboratory values within 30 dyas of enrollment to study defined as follows: 1) neutrophil \> 2000/mm\^3; 2) platelet \> 100,000/mm\^3; 3) total bilirubin \< 1.5mg/dl; 4) alanine aminotransferase/aspartate aminotransferase \< 1.5 upper limit of normal; 5) SCr \< 1.5mg/dl; creatinine clearance rate \> 60ml/min. * Willing to accept adequate contraception for women with childbearing potential. * Willing to sign the written informed consent; Informed consent must be signed before the enrollment in the trial. Exclusion Criteria: * Presence of distant metastasis. * Without measurable lesion. * Previous history of malignant tumor (within 5 years) or simultaneous existence of multiple primary tumors. * Accompanied with severe major organ dysfunction. * Presence of mental disease that may influence the understanding of informed consent.
References
Publications (0)
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