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临床试验/ACTRN12623001098628
ACTRN12623001098628
尚未招募
未知

Interim Magnetic Resonance Imaging (MRI), fluorodeoxyglucose (FDG)-positron emission tomography (PET), and circulating tumour human papillomavirus (HPV) DNA during chemoRadiotherapy In p16-positive AnaL squamous cell carcinoma: The IMPERIAL Study

South Western Sydney Local Health District0 个研究点目标入组 28 人2023年10月20日

概览

阶段
未知
干预措施
未指定
疾病 / 适应症
Anal Cancer
发起方
South Western Sydney Local Health District
入组人数
28
状态
尚未招募
最后更新
2年前

概览

简要总结

暂无简介。

注册库
who.int
开始日期
2023年10月20日
结束日期
待定
最后更新
2年前
研究类型
Interventional
性别
All

研究者

入排标准

入选标准

  • Age greater than or equal to 18
  • \- Patient willing and able to give written informed consent
  • \- Patient deemed suitable for CRT treatment protocol as determined by both a medical oncologist and a radiation oncologist
  • \- Biopsy confirming histological diagnosis of primary invasive anal squamous cell carcinoma, and documentation of p16 immunohistochemistry status
  • \- TNM stage T1\-T4 N0\-N1 M0 (AJCC 8th edition), determined by
  • \-Clinical groin examination
  • \-EUA or anoscopy\- CT chest, abdomen and pelvis (with IV contrast unless contraindicated)
  • \-Documentation of size of primary lesion

排除标准

  • Women lactating, pregnant or of childbearing potential with inadequate contraception
  • \- Patients who have previously received systemic therapy for anal cancer, or previous radiotherapy to the pelvis
  • \- Previous HPV\-related malignancy within the last 3 years
  • \- Macroscopic surgical resection of the primary anal cancer
  • \- P16 negative on immunohistochemical staining (note: equivocal staining pattern not an exclusion)
  • \- ECOG performance status \>2
  • \- Patients with significant medical or psychosocial conditions that may impact their ability to understand or complete the treatment protocol and study requirements
  • \- Distant metastatic disease (M1\)
  • If enrolled into the MRI sub\-study:
  • \- Inability to have an MRI due to severe claustrophobia, implanted incompatible devices (including pacemakers and implantable defibrillators) or magnetic material (e.g. bullet shrapnel, intraocular metal).

结局指标

主要结局

未指定

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