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
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。
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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