NL-OMON23939招募中不适用
Combination of chemoTherapy aNd chemoradioTherapy for adenocarcinoma of the OESophagus and gastro-oesophageal junction with oligometastatic disease
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Erasmus MC
- 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
入排标准
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
- •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.
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
- •13. Language difficulty, dementia or altered mental status prohibiting the understanding and
- •giving of informed consent and to complete quality of life questionnaires;
研究者
相似试验
尚未招募
2 期
Combination of chemoTherapy aNd chemoradioTherapy for adenocarcinoma of the OESophagus and gastro-oesophageal junction with limited metastatic disease - TNT-OES-1 TRIAesophageal cancerNL-OMON49762Erasmus MC, Universitair Medisch Centrum Rotterdam20
进行中（未招募）
1 期
Chemotherapy followed by chemoradiotherapy for metastatic esophageal cancerPatients (18 – 75 years) who are diagnosed with adenocarcinoma of the oesophagus or GOJ with a resectable primary tumour and de-novo synchronous oligometastatic disease.EUCTR2020-003605-55-NLErasmus MC - University Medical Centre20
进行中（未招募）
不适用
ow-doses radiotherapy and concomitant chemotherapy with pemetrexed in progression desease NSCLC: a dose-descalation phase II study - NDadvanced and/or metastatic NSCLCMedDRA version: 9.1Level: LLTClassification code 10059515Term: Non-small cell lung cancer metastaticEUCTR2008-003690-40-ITPOLICLINICO UNIVERSITARIO AGOSTINO GEMELLI
尚未招募
3 期
Chemoradiation and Consolidation Chemotherapy with or without oxaliplatin for distal rectal cancer and Watch and Wait. A multi-center prospective randomized controlled trial. (CCHOWW)RBR-5j3j9z9Hospital Alemão Oswaldo Cruz
已完成
不适用
Alternating Chemotherapy and Radiotherapy in Advanced Laryngeal Cancersaryngeal cancerJPRN-UMIN000007001Aichi Cancer Center26