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临床试验/NCT02388698
NCT02388698Unknown不适用

FDG-PET and Circulating HPV in Patients With Cervical Cancer Treated With Definitive Chemoradiation

Sunnybrook Health Sciences Centre2 个研究点 分布在 1 个国家目标入组 84 人开始时间: 2016年11月23日最近更新:
适应症

试验速览

阶段
不适用
入组人数
84
试验地点
2
主要终点
Change from baseline in plasma HPV DNA to 3 months.

研究概览

简要总结

The addition of concurrent chemotherapy to definitive radiation has improved the 5-year survival of women with locally advanced cervical cancer to 58%. To determine if plasma HPV DNA predates clinical recurrence and/or improves the accuracy of metabolic response on FDG-PET at 3 months post completion of radical chemo-radiation in patients with locally advanced cervical cancer. Post therapy FDG-PET can help predict progression free survival and overall survival. In addition plasma HPV can be used to monitor response and detect early recurrence. Prospective study will recruit 20 patients with locally advanced cervical cancer to determine if plasma HPV DNA predates clinical recurrence and/or improves the accuracy response on post-therapy FDG-PET scan at 3 months.

详细描述

The addition of concurrent chemotherapy to definitive radiation has improved the 5-year survival of women with locally advanced cervical cancer to 58%, there is much room for improvement. Post-therapy FDG-PET at 3 months can help predict progression-free and overall survival. Tumors continually shed their DNA into the circulation, where it can be accessed to measure disease burden. Cervical cancer is caused by Human Papilloma Virus (HPV); plasma HPV DNA could be used to monitor response and detect recurrence early. While plasma HPV DNA has been shown to correlate with prognosis and predict recurrence in other cancers, there is limited data in locally advanced cervical cancer.

This prospective multi-institutional study will recruit 20 patients with locally advanced cervical cancer to determine if plasma HPV DNA predates clinical recurrence and/or improves the accuracy response on post-therapy FDG-PET scan at 3 months. Patients will undergo phlebotomy at the following time-points for the measurement of circulating HPV DNA levels: a) baseline; b) end of radiotherapy;c) 3 months post completion of chemoradiation, along with 3-month FDG-PET and d) at recurrence. This study will provide preliminary estimates of the correlation between plasma HPV DNA level, PET finding and clinical outcome, and inform sample size calculation for a larger study. If proven useful in the future, plasma HPV DNA could enable the identification of patients at high risk of recurrence and individualized treatment.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Histologically confirmed squamous cell carcinoma, adenocarcinoma or adenosquamous carcinoma of the cervix, FIGO stage IB-IVA
  • planned for radical radiotherapy and concurrent cisplatin chemotherapy.
  • Age ≥ 18 years.
  • Life expectancy of greater than 3 months.

排除标准

  • Evidence of distant metastases (suspicious paraaortic nodes below the renal vessels allowed if they will be encompassed within the radiation field)
  • Patients who have received any anticancer treatment for their cervical cancer.
  • Eastern Cooperative Oncology Group (ECOG) performance status > 2
  • Other cervical cancer tumor histologies (e.g. small cell, serous)
  • Contraindications to 18FDG PET-CT
  • Inability to lie supine for radiation and/or 18FDG PET-CT
  • Contraindication to radiotherapy (e.g. severe Crohn's disease)
  • Contraindication to chemotherapy (e.g. non-reversible renal failure)
  • History of another invasive malignancy, except for non-melanoma skin cancer or tumors curatively treated with no evidence of disease for ≥ 5 years.
  • Known pregnancy or lactating

结局指标

主要结局

Change from baseline in plasma HPV DNA to 3 months.

时间窗: Pre treatment and within the first 3 months post treatment

To determine if HPV DNA predates clinical recurrence and/or improves the accuracy of metabolic response on FDG-PET scan at 3 months post completion of radical chemoradiation in patients with locally advanced cervical cancer

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr. Eric Leung

Radiation Oncologist

Sunnybrook Health Sciences Centre

研究点 (2)

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