Nasopharyngeal Carcinoma
Conditions
Keywords
re-irradiation, carbon ion radiotherapy
Brief summary
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.
Detailed description
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 starting from 55GyE (2.5GyE/daily fraction) to potentially 65GyE (2.5GyE/daily fraction) 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. Time-to-event continual reassessment method (TITE-CRM) is used for the phase I dose escalating part of the trial and approximately 25 patients will be accrued. 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. The Phase II part of the trial will be a single phase single arm study.
Interventions
RADIATIONCarbon ion radiotherapy (CIRT)
Five dose levels (55GyE, 57.5GyE, 60GyE, 62.5GyE, 65GyE) are planned within the Phase I part. Daily fraction of 2.5 GyE will be delivered for all dose levels. After the recommended dose (RD), i.e., MTD, is determined or if the treatments to 65 GyE are safely delivered, the recommended dose (or 65 GyE) will be the prescribed dose in the Phase II part of the study. Ninty-five percent (95%) of the isodose line should cover the GTV+3\ 5mm.
Sponsors
Shanghai Proton and Heavy Ion Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 | Time interval from the start of CIRT to 4 months after the completion of CIRT |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival of all patients | From the diagnosis of local recurrence of NPC, a median of 2 years |
| Progression-free survival of all patients | From the completion of CIRT, a median of 2 years |
Countries
China
Outcome results
None listed