A Cross sectional study to estimate the Incidenceof Second primary Cancers in patients with locally advanced non-nasopharyngeal Head and Neck Squamous Cell Carcinoma (HNSCC) treated with radical, non-surgical methods

A0 个研究点目标入组 656 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•Only those patients who have completed planned protocol treatment
•Have complete follow-up information till last event or death, whichever was later
•After IRB approval all data will be collected according to the case record form (CRF)
•All patients will be deemed as having a second primary if they satisfy the following criteria [Warren & Gates, NCI (2006) & Hong]:
•1.Both neoplasms must be malignant, confirmed by histopathology, and in a different location from the index cancer.
•2.The two neoplasms must be anatomically separated by normal non neoplastic mucosa. If the lining mucosa demonstrates dysplasia, it is considered a multicentric primary neoplasm.
•3.A second primary tumor that developed at the same site as an index tumor but occurred more than 3 years later will also be considered a second primary tumor.
•4.To exclude the possibility that the secondarily-developed primary tumor represents a metastasis or local recurrence, it must be separated from the first tumor by at least 2 cm of normal epithelium, or it would occur at least 3 years after the first diagnosis.
•5.The SPM will be considered â??â??metachronousâ??â?? if it developed more than 6 months after an index cancer diagnosis.

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