Combination of chemoTherapy aNd chemoradioTherapy for adenocarcinoma of the OESophagus and gastro-oesophageal junction with limited metastatic disease - TNT-OES-1 TRIA

Phase 2

Conditions: cancer of the esophagus
esophageal cancer
10017990

Registration Number: NL-OMON49762

Lead Sponsor: Erasmus MC, Universitair Medisch Centrum Rotterdam

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 20

Inclusion Criteria

- adenocarcinoma of the esophagus or gastro-esophageal junction with limited
but distant retroperitoneal and/or supraclavicular lymphatic dissemination
and/or maximum of 4 oligo metastases
- resectable primary esophageal tumor
- age 18-75
ECOG performance status 0-1
No prior radiotherapy or chemotherapy

Exclusion Criteria

Polyneuropathy grade 1 or higher
Secondary primary cancer
Clinically significant cardiac disease (e.g. symptomatic coronary artery
disease or myocardial infarction within last 12 months)
Clinically significant pulmonary disease (Forced expiratory volume in 1 second
<1.5l)

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary outcome is the feasibility of the combined regimens (defined as the<br /><br>number of patients that complete the administration of four cycles of FLOT CT<br /><br>and the full CROSS CRT regimen). </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary outcomes are the number of patients that have progressive disease<br /><br>after four cycles of FLOT CT, disease control rate (DCR) and objective response<br /><br>rate (ORR), both according to RECIST 1.1, serious adverse events and adverse<br /><br>events according to Common Terminology Criteria for Adverse Events (CTCae)<br /><br>v4.0, cumulative administered dose of FLOT and number of cycles of<br /><br>carboplatin/paclitaxel administered as part of CROSS CRT, progression free<br /><br>survival [PFS], overall survival [OS], number of patients with a clinically<br /><br>complete response, QoL, the number of patients proceeding to local therapy of<br /><br>distant metastases and/or oesophagectomy and tolerability of the combined<br /><br>regimens of 4x FLOT CT followed by CROSS CRT followed by another 4x FLOT CT<br /><br>(defined as the number of patients that complete the administration of four<br /><br>cycles of FLOT, CROSS CRT and another four cycles of FLOT). </p><br>