Study of the Value of the PET/CT in Evaluating the Response of Distal Rectal Cancer to Neoadjuvant Chemoradiation Therapy
试验速览
- 阶段
- 2 期
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- PET/CT specificity and sensitivity for tumor response
研究概览
简要总结
Preoperative chemoradiation therapy is the preferred initial treatment option for distal rectal cancers. However, assessing tumor response to preoperative chemoradiation therapy remains a challenge to the colorectal surgeon, especially when determining if there is a complete response, observed in more than 10% of cases. The purpose of this study is to evaluate the use of the PET/CT in assessing distal rectal tumor response to preoperative chemoradiation therapy.
详细描述
Patients with distal rectal adenocarcinoma will be submitted to an initial whole body PET/CT prior to the preoperative chemoradiation therapy with 5-fluorouracil and 5040 cGy. Six weeks and 12 weeks after the preoperative treatment is finished the PET/CT will be repeated. At 1 and at 2 years after preoperative treatment is concluded another PET/CT will be performed. The colorectal surgeon evaluating the response to chemoradiation therapy will be blinded to the results of the PET/CT, as the radiologist will be blinded to the response assessment. PET/CT results will not be used to determine treatment strategy, unless metastatic disease or other disease is diagnosed. Patients with a complete clinical response at 8 weeks will be rigorously followed while patients with an incomplete clinical response at 8 weeks will be submitted to radical surgery. PET/CT results will be compared to current radiological studies and final pathological reports.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of Rectal Adenocarcinoma
- •Location of Tumor less than 7cm from Anal Verge
排除标准
- •Pregnancy or Nursing
- •Metastatic Disease (Stage IV disease)
- •Previous treatment for any cancer
- •Patients clinically unable to receive neoadjuvant chemoradiotherapy
- •Hypersensitivity to 18FDG
结局指标
主要结局
PET/CT specificity and sensitivity for tumor response
时间窗: Response assesment at 6 and 8 weeks following neoadjuvant therapy
次要结局
- Correlation between PET/CT and complete clinical Response(2 years following completion of neoadjuvant therapy)