Multicenter Study to Perioperative Chemotherapy for Resectable Adenocarcinoma in Gastric Cancer
Recruitment status was: Active, not recruiting
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.
|Gastric Cancer||Drug: Docetaxel 50 mg/m2, 1-hour-Infusion, day 1 Drug: Oxaliplatin 85 mg/m², 2-hour-Infusion, day 1 Drug: Folinic acid 200 mg/m², 1-2-hour-Infusion, day 1 Drug: 5-FU 2600 mg/m², 24-hour-Infusion, day 1||Phase 2|
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
- Collection of the R0-Resection rate [ Time Frame: 12 weeks ]after 6 cycles of biweekly FLOT chemotherapy and operation.
|Study Start Date:||December 2009|
|Estimated Study Completion Date:||May 2014|
|Estimated Primary Completion Date:||May 2011 (Final data collection date for primary outcome measure)|
Docetaxel, Oxaliplatin, Folinic acid, 5-FU, q 2 weeks, application of 6 cycles
Drug: Docetaxel 50 mg/m2, 1-hour-Infusion, day 1
50 mg/m2, 1-hour-Infusion, day 1Drug: Oxaliplatin 85 mg/m², 2-hour-Infusion, day 1
85 mg/m², 2-hour-Infusion, day 1Drug: Folinic acid 200 mg/m², 1-2-hour-Infusion, day 1
200 mg/m², 1-2-hour-Infusion, day 1Drug: 5-FU 2600 mg/m², 24-hour-Infusion, day 1
2600 mg/m², 24-hour-Infusion, day 1
Please refer to this study by its ClinicalTrials.gov identifier: NCT01160419
|University of Munich, Klinikum Grosshadern|