NCT01160419

Multicenter Study to Perioperative Chemotherapy for Resectable Adenocarcinoma in Gastric Cancer

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 49 (estimated)
• Sponsor: Ludwig-Maximilians - University of Munich · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The rationale of the NEO-FLOT-trial consists of an intensification of the neoadjuvant treatment. This strategy is based upon the clear advantage of perioperative treatment and the fact, that in former trials adjuvant treatment could only be given in half of the patients (Cunningham 2006, Boige 2007). In this study neoadjuvant chemotherapy is applied during a period of 12 weeks with an interim staging after 6 weeks.Due to the favourable efficacy and toxicity data the FLOT-regimen was chosen for the neoadjuvant treatment consisting of oxaliplatin, docetaxel, folinic acid and 5-Fluorouracil (Al-Batran 2008). Postoperative treatment according to the results of the MAGIC trail is not part of the trail and is given at the responsibility of the participating centres.

Conditions

• Gastric Cancer

Interventions

Type	Name	Description
DRUG	Docetaxel 50 mg/m2, 1-hour-Infusion, day 1	50 mg/m2, 1-hour-Infusion, day 1
DRUG	Oxaliplatin 85 mg/m², 2-hour-Infusion, day 1	85 mg/m², 2-hour-Infusion, day 1
DRUG	Folinic acid 200 mg/m², 1-2-hour-Infusion, day 1	200 mg/m², 1-2-hour-Infusion, day 1
DRUG	5-FU 2600 mg/m², 24-hour-Infusion, day 1	2600 mg/m², 24-hour-Infusion, day 1

Timeline

• Start date: 2009-12-01
• Primary completion: 2011-05-01
• Completion: 2014-05-01
• First posted: 2010-07-12
• Last updated: 2010-10-28

Locations

1 site across 1 country: Germany