Evaluation of Individual Radiosensitivity of Cancer Patients to be Treated by Radiotherapy or Radiochemotherapy Per-operative
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 97
- 试验地点
- 12
- 主要终点
- Calibration of the correlation between the clinical tumor response and the results of A/MS bioassays using tumor samples
研究概览
简要总结
THEODORA is a prospective pilot clinical trial aiming at first to evaluate and validate the predictive value of the A & MS bioassays on tumor control by radiotherapy.
详细描述
For that purpose, this project is composed of 3 stages:
- A Calibration stage that will allow to evaluate the correlation between the clinical tumor response parameters (i.e. TV/AP features) and the radiobiological parameters issued from the A/MS bioassays in order to develop a mathematic model defining the UTCR parameter
- A Validation stage in order to assess the validity of A/MS bioassays towards clinical tumour response parameters (i.e. both TV/AP features and UTCR).
- A Precision stage will be performed either to improve the precision of the predictive performance of the A and MS bioassays or to establish a new mathematical model describing the correlation between clinical and radiobiological parameters. The objective of this precision stage will depend of the results of the calibration stage (see below).
This prospective clinical study will be conducted in a population of patients with different tumor types in order to explore a large range of tumor radiosensitivity including sarcomas, rectal carcinoma and esophagus tumor.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
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
- •Patients (male or female) ≥ 18 years of age. I
- •Adult patients with a suspected, non-treated, non-metastatic retroperitoneal or limb soft tissue sarcoma, esophagus cancer or rectum cancer to be treated by pre-operative radiotherapy or radio-chemotherapy I
- •At least one measurable lesion as per RECIST 1.1 I
- •Documented negative serology tests (HVB, HIV, HVC) I
- •PS ECOG 0 to 1 I
- •Patient able and willing to provide informed consent. I
- •Ability to understand and willingness for follow-up visits. I
- •Covered by a medical insurance.
排除标准
- •Contra-indication to radiotherapy E
- •Contra-indication to skin biopsy
结局指标
主要结局
Calibration of the correlation between the clinical tumor response and the results of A/MS bioassays using tumor samples
时间窗: 2.5 years (after 100 patients enrolled )
The calibration stage will be performed using data from the first 40 patients enrolled. All the potential correlations between the clinical and radiobiological parameters will be tested. The links between clinical tumor response parameters and radiobiological parameters derived from MS/A bioassays using tumor samples.
Validation of the correlation between the clinical tumor response and the results of A/MS bioassays using tumor samples
时间窗: 2.5 years (after 100 patients enrolled )
The validation stage will be performed using data from the remaining 60 patients enrolled. This stage will assess whether or not the prediction of tumor response derived from the A/MS bioassays fits with the observed tumor response after RT.
次要结局
- Validation of the correlation between the healthy tissue response (i.e. AE reported as per CTCAE v4) and the results of MS/A bioassays using skin biopsies(2.5 years (after 100 patients enrolled ))