Multicentre phase 2 study of neoadjuvant oxaliplatin and capecitabine followed by chemo-radiotherapy in patients with locally advanced carcinoma of esphago-gastric junction. - INduction Oxaliplatin and Xeloda in Esophago-Gastric Junction cancer

Istituto Nazionale per lo Studio e la Cura dei Tumori di Napoli – Fondazione G.Pascale”0 个研究点目标入组 40 人开始时间: 2013年6月20日最近更新: 2018年2月19日

适应症

试验速览

暂无简介。

•- Carcinoma of the esophagogastric junction Siewert type I and II locally advanced (T2-3-4, N +) documented by histology and / or cytology
•? Age = 18 and = 75 years
•? Presence of at least one target lesion according to RECIST
•? Performance Status ECOG = 0-1
•? Adequate bone marrow , hepatic and renal function
•? Estimated life expectancy> 3 months
•? Written informed consent
•? Carcinoma of the esophagogastric junction Siewert type I and II sec locally advanced (T2-3-4, N +) documented by histology and / or cytology
•? Age = 18 years and = 75 years
•? Presence of measurable target lesions according to RECIST
•? Performance Status ECOG = 0-1
•? Lack of significant changes in bone marrow function, hepatic and renal
•? estimated life expectancy> 3 months
•? Written informed consent
•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 35
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 5

•? Distant metastases
•? Previous systemic medical treatment or radiotherapy for neoplastic disease
•? Presence of concomitant and / or previous malignancies
•? Presence of acute or chronic infectious states requiring systemic medical therapies.
•? Significant cardiovascular disease (myocardial infarction, unstable angina, congestive heart failure, arrhythmias) occurred less than 18 months prior to the enrollment
•? Cerebro-vascular disorders
•? Venous or arterial thromboembolism in place
•? Severe respiratory diseases
•? Inflammatory Bowel diseases
•? Known Seropositivity for HIV
•? Acute or chronic HBV or HCV hepatitis
•? Peripheral neuropathy of any etiology
•? Hepatic or renal impairment
•? Any other clinically significant systemic disease that can make the patient unsuitable for study treatment
•- Major surgery ??less than 28 days, or minor surgical procedure practiced less than 14 days before the start of treatment (excluding the placement of CVC)
•? Pregnant or breastfeeding
•? Dementia or other significant condition of altered mental status that may affect the ability of understanding of the scope of the study by the patient and the proper granting of informed consent

发起方

Istituto Nazionale per lo Studio e la Cura dei Tumori di Napoli – Fondazione G.Pascale”