Multicentre phase 2 study of neoadjuvant oxaliplatin and capecitabine followed by chemo-radiotherapy in patients with locally advanced carcinoma of esphago-gastric junction.

Phase 1

• Conditions: ocally advanced carcinoma (squamous or adenocarcinoma) of the esophago-gastric junction Siewert type I and II; MedDRA version: 14.1Level: LLTClassification code 10056267Term: Gastroesophageal cancerSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2013-001630-18-IT
• Lead Sponsor: Istituto Nazionale per lo Studio e la Cura dei Tumori di Napoli – Fondazione G.Pascale”

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-06-20
• Last Update Posted: 19 February 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

- 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

Exclusion Criteria

? 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess the activity in terms of pathological complete response rate (pCR) of a neoadjuvant treatment with XELOX followed by chemo-RT in patients with locally advanced (stage IB-III) carcinoma of the esophagogastric junction .;Secondary Objective: • To evaluate:<br>objective response rate<br>toxicity<br>rate of R0 resections<br>progression-free survival (PFS)<br>overall survival (OS)<br><br>• To validate the predictive role of early metabolic changes of the tumor measured by PET / CT<br>• To evaluate the prognostic role of the immunocompetent cell subsets CD4, CD8, CD20, CD57, CD68;Primary end point(s): rate of complete pathologic response;Timepoint(s) of evaluation of this end point: surgery (about 21 weeks from study start)

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): objective response rate <br>toxicity<br>R0 resection rate<br>PFS<br>OS;Timepoint(s) of evaluation of this end point: objective response rate: week 20 <br>toxicity: every week<br>R0 resection rate: surgery (about week 21)<br>PFS: week 20 and every 3 months later<br>OS. death