EUCTR2020-003605-55-NL进行中（未招募）1 期
Combination of chemoTherapy aNd chemoradioTherapy for adenocarcinoma of the OESophagus and gastro-oesophageal junction with oligometastatic disease - TNT-OES-1 TRIA
Erasmus MC - University Medical Centre0 个研究点目标入组 20 人开始时间: 2020年11月11日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •In order to be eligible to participate in this study, a subject must meet all of the following criteria:
- •1.Histologically-proven, resectable adenocarcinoma of the oesophagus or GOJ according to the UICC TNM7 definition (appendix 2). Tumours of the oesophagus and tumours of which the epicentre is within 5 cm of the GOJ are eligible for inclusion in the trial in the case of adenocarcinomatous histology (Type 1 and Type 2 according to Siewert classification of oesophagogastric adenocarcinoma)
- •2.Pre-treatment stage cT1N+ M1 or cT2-4a N0/N+, M1 (In case of stage cT4a, curative resectability has to be explicitly verified by the multidisciplinary tumour board.
- •3.Oligometastatic disease, which for this study is defined as a maximum of four resectable/treatable metastatic lesions. These four lesions can be present in a maximum of two organs (liver, lung, bones, or adrenal gland). Lymph nodes are not counted as an organ. If metastatic retroperitoneal or supraclavicular lymph nodes are present, this lymph node site counts as one metastatic lesion, and together with the possible metastases in organs cannot exceed the four lesions.
- •4. Age?=?18 years, <75 years.
- •5. No prior abdominal, thoracic or cervical radiotherapy overlapping with the CROSS irradiation fields.
- •6.No prior cytotoxic chemotherapy
- •7.Eastern Cooperative Oncology Group (ECOG) performance status 0-1 (see Appendix 1)
- •8.Adequate cardiac function (cardiac function tests such as echocardiography only necessary in symptomatic patients).
- •9.Adequate respiratory function (pulmonary function tests only necessary in symptomatic patients)
- •10.Adequate bone marrow function (White Blood Cells >3x10^9/l; Haemoglobin?mmol/L; platelets >100x10^9/l). In the event of transfusions, the last red blood cell transfusion should be more than 2 weeks before inclusion.
- •11.Adequate renal function (Glomerular Filtration Rate >50 ml/min) or Serum creatinine <=1.5 x upper limit of normal (ULN) and adequate liver function (Total bilirubin <1.5x Upper Level of Normal (ULN); Aspartate transaminase (AST) <2.5x ULN and Alanine transaminase (ALT) <3x ULN
- •12.Written informed consent and ability to understand the nature of the study and the study-related procedures and to comply with them
- •13.Women of child-bearing potential must have a negative serum pregnancy test during screening period.
- •14.Patients must be willing to use adequate contraception during the study and for 3 months after the end of the study.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 10
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 10
排除标准
- •A potential subject who meets any of the following criteria will be excluded from participation in this study:
- •1.Patients with tumours of squamous, adenosquamous or other non-adenocarcinoma histology
- •2.Patients with advanced irresectable or extensive metastatic oesophageal adenocarcinoma (involving 3 or more organs or more than 4 metastatic lesions)
- •3.Patients with overt peritoneal dissemination, as detected on PET-CT or regular CT-scan. In patients in whom a diagnostic laparoscopy is indicated, tumour-positive cytology peritoneal fluid is also an exclusion criterion
- •4.Oesophageal adenocarcinoma evaluated as not curatively-resectable by the multidisciplinary tumour board , for instance because ingrowth in the trachea
- •5.Gastric carcinoma (according to UICC TNM7)
- •6.Clinically significant (active) cardiac disease (e.g. symptomatic coronary artery disease or myocardial infarction within last 12 months)
- •7.Clinically significant lung disease (Forced Expiratory Volume in one second (FEV1) <1.5 l)
- •8.Peripheral neuropathy grade >1 according to CTCae v4.0
- •9.Pregnant and lactating women, or patients of reproductive potential who are not using effective birth control methods. If barrier contraceptives are used, they must be continued by both sexes throughout the study.
- •10.Participation, current or during the last 30 days prior to informed consent, in another intervention trial with interference to the chemotherapeutic or chemoradiotherapeutic intervention of this study
- •11.Expected lack of compliance with the protocol
- •12.Secondary primary cancer with the exclusion of basal cell carcinoma of the skin
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