Clinical trial · Interventional
Trail Evaluating Carbon Ion Radiotherapy for Locally Recurrent Nasopharyngeal Carcinoma
Phase I/II Trail Evaluating Carbon Ion Radiotherapy 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
Why stopped (as posted): Slow accrual of patients.
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) 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 maximal tolerated dose (MTD) in terms of acute and subactue toxicity observed during and 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
- description
- Patients included in this arm were treated with carbon ion radiotherapy (CIRT).
- interventionNames
- Radiation: Carbon ion radiotherapy (CIRT)
Primary outcomes (1)
- measure
- Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
- timeFrame
- Time interval from the start of CIRT to 4 months after the completion of CIRT
Secondary outcomes (2)
- measure
- Overall survival of all patients
- timeFrame
- From the diagnosis of local recurrence of NPC, a median of 2 years
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Pathologically confirmed NPC * 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 ≥ 14 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: * Local recurrence of NPC diagnosed within 12 months from the completion of previous course of radiation therapy * 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 CIS of the cervix, BCC and SCC of the skin within the past 5 years * Refusal of the patient to participate into the study
References
Publications (0)
Data not yet available