Clinical trial · Interventional
Trail Evaluating Carbon Ion Radiotherapy (3 GyE Per Fraction) for Locally Recurrent Nasopharyngeal Carcinoma
Phase I/II Trail Evaluating Carbon Ion Radiotherapy (3 GyE Per Fraction) for Salvaging Treatment of Locally 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 purpose of this study is to determine the maximal tolerated dose (MTD) of re-irradiation using carbon ion radiotherapy (CIRT) with the fraction size of 3 gray equivalent (GyE) in the treatment of locally recurrent nasopharyngeal cancer (NPC) and to evaluate the efficacy of such treatment at the MTD. Participants will be treated with CIRT with escalating dose regimens to evaluate the MTD in terms of acute and subacute toxicity observed within 4 months after the completion of CIRT. Once the MTD for locally recurrent NPC is determined, the MTD will be used as the recommended dose to patients fulfilling the inclusion criteria in the Phase II part of the trial.
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 |
|---|---|---|---|
| Carbon ion radiotherapy (CIRT) | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- CIRT Arm (3GyE per fraction)
- description
- Patients included in this arm were treated with carbon ion radiotherapy with a fraction size of 3GyE.
- interventionNames
- Radiation: Carbon ion radiotherapy (CIRT)
Primary outcomes (2)
- measure
- Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 (phase 1)
- timeFrame
- Within 4 months after the completion of treatment
- description
- The primary objective of phase 1 is to identify the maximum tolerated dose which is defined as the highest dose associated with a probability of dose limiting toxicity \<=25%.
- measure
- Phase 2: Overall survival (OS)
- timeFrame
- 2 years
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Completed a definitive course of intensity-modulated photon radiation therapy (IMXT) to a total dose of ≥ 66 Gy * Recurrence diagnosed more than 12 months after the initial course of IMXT * Age ≥ 18 and \< 70 years of age * Karnofsky Performance Score ≥70 * Willing to accept adequate contraception for women with childbearing potential * Ability to understand character and individual consequences of the clinical trial * Willing to sign the written informed consent; Informed consent must be signed before the enrollment in the trial Exclusion Criteria: * Presence of distant metastasis * Technology used other than IMXT (including brachytherapy following IMXT) for the treatment of initial diagnosis of NPC * Pregnant or lactating women * Patients who have not yet recovered from acute toxicities of prior therapies * A diagnosis of malignancy other than carcinoma in situ of the cervix, basal cell carcinoma and squamous cell carcinoma of the skin within the past 5 years
References
Publications (0)
Data not yet available