CTRI/2024/02/062497尚未招募3 期
eoadjuvant chemoradiation Vs Neoadjuvant chemotherapy followed by surgery in patientswith resectable squamous cell carcinoma of the esophagus (NARCOS): A ProspectiveRandomised Phase III study - NARCOS
TMH TRAC0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
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
- •1.Histologically documented untreated SCC of the esophagus.
- •2.Primary tumor of the esophagus located in the thoracic cavity. The proximal extent would be at least 5 cm from the upper esophageal sphincter and the distal extent up to the gastroesophageal (GE) junction. The length and width of the tumor will not exceed 8 cm and 5 cm, respectively. However, patients with mid- esophageal tumors and tracheoesophageal nodes would be included.
- •3.Pre-treatment stage as cT2 4aN0 2M0 (AJCC or UICC 8th Edition) (In the case of stage cT4a, curative resectability must be explicitly verified by the local surgical investigator before randomization).
- •4.Age - between 18 years and 75 years.
- •5.Patients having an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
- •6.Adequate cardiac function. Patients with a cardiac history or ECG abnormality will undergo echocardiography and be included if the left ventricular ejection fraction is =55%.
- •7.Patients with adequate pulmonary function assessed with a pulmonary function test (PFT) or DLCO would be included. FEV1 should be greater than or equal to 50 percent or DLCO greater than or equal to 50 percent in PFT.
- •8.Adequate bone marrow function (haemoglobin greater than 8 gm per Lit, platelets greater than 100 multiplied 109 per Lit, absolute neutrophil count (ANC) greater than 1.5 multiplied 109 per Lit.
- •9.Adequate liver function (Total bilirubin less than 2 multiplied Upper Level of Normal (ULN), Aspartate transaminase (AST) and Alanine transaminase (ALT) less than 2.5 multiplied ULN).
- •10.Adequate renal function (Creatinine clearance (CrCl) greater than 40 ml per min Carboplatin dose calculation as per AUC.
- •11.The patient has provided written informed consent and can understand and comply with the study.
排除标准
- •1. Patients with non-squamous cell carcinoma histology
- •2. Patients with advanced inoperable or metastatic esophageal cancer;
- •3. Patients with lower esophageal tumors with supraclavicular nodes or upper or mid esophageal tumors with gastrohepatic or coeliac nodes.
- •4. Pre-treatment stage as cN3 or cT4b.
- •5. Patients with another previous or current malignant disease that is likely to interfere with treatment or the assessment of response in the judgment of the local surgical investigator.
- •6. Any patient with a significant medical condition due to which the patient is unlikely to tolerate the therapies. Such as cardiac disease (e.g. symptomatic coronary artery disease or myocardial infarction within the last 12 months),
- •clinically significant lung disease, clinically significant bone marrow, liver, and renal function disorder.
- •7. Pregnant or lactating and fertile women who will not be using contraception during the trial.
- •8. Expected lack of compliance with the protocol.
- •9. Patients who have received any previous treatment for oesophageal cancer.
- •10.Patients are unsuitable for surgery because of comorbidities.
研究者
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