CTRI/2017/07/009114招募中2 期
Adjuvant Radiotherapy in Early Stage Oral Cancers (AREST) ââ?¬â?? aprospective randomized control trial - AREST
ational Cancer Grid0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1.Post-operative early stage squamous cell carcinoma of oral cavity (Oral Tongue, Buccal Mucosa, Floor of mouth).
- •(pT1, pT2, N0 as defined in the AJCC Classification 8th edition.
- •pT2 is defined in AJCC 8th edition as
- •i. Tumor < 2cm and depth of invasion > 5mm and ââ?°Â¤ 10mm.
- •ii. Tumor > 2cm but ââ?°Â¤ 4cm and depth of invasion (DOI) ââ?°Â¤ 10mm.)
- •2.Adequate surgery (Defined as wide local excision of primary tumor with tumor free margin ââ?°Â¥ 5mm and ipsilateral selective neck dissection addressing levels I-III at minimum.)
- •3.Written informed consent.
- •4.Age ââ?°Â¥18 years
- •5.Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2
- •6.Depth of invasion (DOI) ââ?°Â¥ 5 mm.
- •7.Compliance to therapy and follow-up
- •8.Interval from surgery to adjuvant radiotherapy ââ?°Â¤ 8 weeks
排除标准
- •1.pT3/pT4 (as specified in the AJCC 8th edition).
- •2.Depth of invasion < 5mm.
- •3.Any neck nodal metastasis with or without extra nodal extension.
- •4.Tumor free margin < 5 mm
- •5.Non-squamous histology
- •6.Pregnant woman
- •7.Prior h/o any other malignancy in the last five years
- •8. Prior therapeutic irradiation of the head and neck.
- •9. Presence of HIV infection
研究者
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