Phase Ⅰ/Ⅱ trial evaluating concurrent carbon-ion radiotherap

发布时间：2023-05-04 02:30

　　Background: After deinitive chemoradiotherapy for non-metastatic nasopharyngeal carcinoma(NPC), more than 10% of patients will experience a local recurrence. Salvage treatments present signiicant challenges for locally recurrent NPC. Surgery, stereotactic ablative body radiotherapy, and brachytherapy have been used to treat locally recurrent NPC. However, only patients with small-volume tumors can beneit from these treatments. Re-irradiation with X-ray—based intensity-modulated radiotherapy(IMXT...

【文章页数】：11 页

【文章目录】：
Background
    Challenges in the re?treatment of locally recurrent NPC
    Characteristics of particle radiotherapy in cancer treatment
    Particle therapy for local recurrence in head and neck cancers
    Concurrent chemotherapy with CIRT for locally recurrent NPC
    Selection of CIRT dose for re?irradiation in the phase I study
Methods and design
    Objectives
        Phase I trial
        Phase II trial
    Trial design and schedule
        Phase I trial:dose escalation to determine MTD
        Phase II trial:treatment at recommended dose to study efficacy
    Inclusion and exclusion criteria
    Induction,concurrent,and adjuvant treatments
        Induction and adjuvant chemotherapy
        Concurrent chemotherapy
        Other medications
    Radiation therapy1
        Treatment planning
        Dose prescription for CIRT
        Treatment planning and delivery
        Assessment of efficacy parameters(see footnote 1)Baseline documentation of“target”lesion
        Response to treatment
        OS
        Progression?free survival
    Assessment of toxicity,safety,and other parameters
        Toxicity and safety parameters
        Other parameters
    Follow-up after trial completion
        Follow-up
        Treatment at tumor progression
    Statistics(see footnote 1)
        Phase I trial
        Phase II trial
Data collection/safety/management and ethical/legal aspects
    Data safety monitoring board
    Data collection and management
    Ethical and legal aspects
Discussion
Authors’contributions



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