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