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Table 2 Inclusion and exclusion criteria for the phase I/II CIRT plus chemotherapy dose escalation trial for NPC

From: Phase I/II trial evaluating concurrent carbon-ion radiotherapy plus chemotherapy for salvage treatment of locally recurrent nasopharyngeal carcinoma

Inclusion criteria Exclusion criteria
Pathologically and/or clinically confirmed locally recurrent NPC diagnosed more than 12 months after completion of initial IMXT
Completed a definitive course of IMXT to a total dose of ≥66 Gy
Age ≥18 and <70 years
KPS score ≥70
Ability to understand the trial protocol, including the aims, methods, and consequences
Willingness to provide written informed consent before enrollment in the trial
Willingness to receive the study treatment, including CIRT and cisplatin-based concurrent chemotherapy
For women with childbearing potential, willingness to use adequate contraception
Presence of distant metastasis
Recurrence diagnosed within 12 months after the completion of the previous IMXT course
Technology used other than IMXT (or IMXT used with other techniques, such as brachytherapy or SRS) for the initial treatment
Pregnant or lactating women
Patients who have not recovered from severe toxicities of prior radiotherapy or chemotherapy
Diagnosis of any type of cancer other than CIS of the cervix and basal cell or squamous cell carcinoma of the skin within the past 5 years
Participation in other clinical trial(s) whose treatments may interfere with the conduct or outcome of this trial
  1. CIRT carbon-ion radiotherapy, IMXT X-ray–based intensity-modulated radiotherapy, KPS Karnofsky performance status, SRS stereotactic radiosurgery, CIS carcinoma in situ