NCT02509286

Perioperative Chemotherapy Compared To Neoadjuvant Chemoradiation in Patients With Adenocarcinoma of the Esophagus

Perioperative Chemotherapy (FLOT Protocol) Compared To Neoadjuvant Chemoradiation (CROSS Protocol) in Patients With Adenocarcinoma of the Esophagus

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 438 (actual)
• Sponsor: University Hospital Schleswig-Holstein · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The trial is designed to investigate differences in outcome of patients with esophageal adenocarcinoma and junctional adenocarcinoma treated with perioperative (neoadjuvant + adjuvant) chemotherapy (FLOT) plus surgical resection versus neoadjuvant chemoradiation (CROSS) plus surgical resection.

Detailed description

According to the given evidence a survival benefit of perioperative chemotherapy (periCTX) over Neoadjuvant chemoradiation (neoCRT) for patients with Esophageal adenocarcinomas (EAC) has not been proven in any randomized controlled trials (RCT). Data supporting the value of periCTX have all been obtained in studies including mixed patient cohorts with EAC and gastric adenocarcinoma (GAC). Due to relevant differences of histologic subtype distribution, response to periCTX and survival rates between EAC and GAC there is a clear need to obtain evidence concerning the value of periCTX for EAC. As nowadays periCTX is extensively and successfully applied in clinical practice in patients with EAC there is an obvious need to obtain evidence from a multicentre RCT. Moreover a confirmation of the superior survival rates of the recent RCT on neoCRT should be obtained in a RCT conducted exclusively on EAC. Therefore, this prospective RCT with the primary objective of longterm patient survival comparing periCTX and neoCRT was designed. Translational Projects: Project 1+2: Circulating Tumor Cells as Biomarker in EAC CTC laboratories at University of Hamburg and University of Freiburg Project 3: Prognostic and predictive biomarkers in EAC University of Leipzig, UCCL

Conditions

• Esophageal Adenocarcinoma (UICC TNM7)
• Adenocarcinoma of the Esophagogastric Junction

Interventions

Type	Name	Description
DRUG	5-Fluorouracil	2600 mg/m² (24 hours), d1 every two weeks;
DRUG	Leucovorin	200 mg/m² in 250 ml NaCl 0.9%, d1 every two weeks;
DRUG	Oxaliplatin	85 mg/m² in 500 ml G5% over 2h, d1 every two weeks;
DRUG	Docetaxel	50mg/m2 in 250 ml NaCl 0.9% over 1h, d1 every two weeks;
DRUG	Carboplatin	Dose-dependant: 2mg/ml/min AUC in 500ml Glucose 5%, day 1, 8, 15, 22 and day 29.
DRUG	Paclitaxel	50mg/m2 in 500ml NaCl 0.9% over 1 h, day 1, 8, 15, 22 and day 29;
RADIATION	Neoadjuvant radiation	41.4Gy given in 23 fractions of 1.8Gy on days 1-5, days 8-12, days 15-19, days 22-26 and days 29-31.

Timeline

• Start date: 2016-01-01
• Primary completion: 2024-05-01
• Completion: 2024-12-31
• First posted: 2015-07-28
• Last updated: 2024-05-08

Locations

30 sites across 1 country: Germany