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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