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 人开始时间: 2023年10月20日最近更新: 2023年10月30日

适应症

试验速览

暂无简介。

•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

•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).

发起方