Planning Adaptive Treatment by Longitudinal Response Assessment Implementing MR Imaging, Liquid Biopsy and Analysis of Microenvironment During Neoadjuvant Treatment of Rectal Cancer (PRIMO)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Tumor regression grading (TRG)
研究概览
简要总结
This pilot study aims to trial multimodal early response assessment to enable therapy adaptions in the context of non-operative therapy strategies of locally advanced rectal cancer (LARC) for development of a non-invasive response prediction model.
详细描述
Patients with LARC, receiving neoadjuvant chemoradiotherapy (CRT) are followed by at least 4 multiparametric MRI-scans (diffusion weighted imaging and hypoxia-sensitive sequences) as well as repeated blood samples in order to analyse circulating tumour cells (CTCs). A standard pelvis radiotherapy (RT, 5040 cGy) will be performed in combination with a 5-Fluorouracil / Oxaliplatin regimen in all patients (planned: N = 50), succeeded by consolidation CTx (FOLFOX4) if feasible. Additional histologic markers, such as tumour-infiltrating lymphocytes (TILs) or PD-L1 status will be analysed before and after CRT. Resection is standard after completion of preoperative treatment. In case of complete regression and patient's request, a non-operative management ("watch and wait") is offered alternatively. The primary endpoint is response, defined by tumor regression grading, secondary endpoints comprise longitudinal changes in MRI as well as in CTCs and TILs.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •locally advanced rectal cancer (LARC): UICC Stage II/III
- •no severe cardiac or lung disease
- •no severe hepatic disorders (liver enzymes <2.5 NR) or restrictions of renal function (GFR > 30ml/min)
- •no severe cytopenia (Neutrocytes >= 3 Gpt/l; Thrombocytes >= 100 Gpt/l; Hemoglobin >6mmol/l)
- •no homozygotic DPD deficiency
- •no other neoplasms requiring therapy
- •no earlier radiotherapy of the pelvis or earlier chemotherapy
- •no contraindications for MRI
排除标准
- 未提供
结局指标
主要结局
Tumor regression grading (TRG)
时间窗: after completion of neoadjuvant treatment (up to 10 months)
Histological response assessment by TRG (Werner / Hoefler et al.); Complete response is defined as TRG 1a;
次要结局
- Tumor Infiltrating Lymphocytes (TIL)(up to 10 months, until resection)
- PFS(5 years)
- OS(5 years)
- MRI(up to 10 months, until resection)
- Circulating Tumor Cells (CTC)(5 years)
- Surrogate marker: Interleukin 6 (IL-6)(5 years)
- Surrogate marker: Carcinoembryonic Antigen (CEA)(5 years)
研究者
Georg Wurschi
Principal Investigator
Jena University Hospital