Clinical trial · Interventional
Proton Versus Photon Radiotherapy for Nasopharyngeal Carcinoma
A Randomized Phase II Trial Evaluating Toxicity and Efficacy Between Proton and Photon for Nasopharyngeal Carcinoma
NCT04528394CI-TRIAL-00115756completedPhase 2ClinicalTrials.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)
The purpose of this study is to compare the toxicity and therapeutic efficacy of proton or photon combined with carbon ion radiotherapy for newly diagnosed nasopharyngeal carcinoma.Participants will be randomized to 2 arms. Arm 1, participants received photon combined with carbon ion radiotherapy group, Arm 2, participants received proton combined with carbon ion radiotherapy.
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 (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Carbon ion | Radiation | — | UNRESOLVED |
| Photon | Radiation | — | UNRESOLVED |
| Proton | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Photon combined with Carbon ion
- description
- The participants received photon: 56 Gy/28 Fx for high-risk area(CTVhigh), 50.4 Gy/28 Fx for lower neck low-risk area(CTVlow), plus carbon ion: 15-17.5 GyE/5 Fx for boost for visible tumors.
- interventionNames
- Radiation: Photon
- Radiation: Carbon ion
- type
- EXPERIMENTAL
- label
- Proton combined with Carbon ion
- description
- The participants received proton: 56 GyE/28 Fx for high-risk area(CTVhigh), 50.4 GyE/28 Fx for lower neck low-risk area(CTVlow), plus carbon ion: 15-17.5 GyE/5 Fx for boost for visible tumors.
- interventionNames
- Radiation: Proton
- Radiation: Carbon ion
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Pathologically confirmed Nasopharyngeal carcinoma(WHO II/III type). * Age ≥ 18 and ≤ 70 years of age. * 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. * Received radiotherapy for head and neck before. * Received surgery(except for biopsy) for primary lesion or cervical lymph node. * Previous history of malignant tumor (within 5 years) or simultaneous existence of multiple primary tumors. * Presence of diseases (such as Sjögren syndrome) that may interfere evaluation of xerostomia. * Accompanied with severe major organ dysfunction. * Presence of mental disease that may influence the understanding of informed consent.
References
Publications (0)
Data not yet available
No reference posted for this study.