Multicenter Study to Perioperative Chemotherapy for Resectable Adenocarcinoma in Gastric Cancer
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|ClinicalTrials.gov Identifier: NCT01160419|
Recruitment Status : Unknown
Verified December 2009 by Ludwig-Maximilians - University of Munich.
Recruitment status was: Active, not recruiting
First Posted : July 12, 2010
Last Update Posted : October 28, 2010
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.
|Condition or disease||Intervention/treatment||Phase|
|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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||49 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Study Start Date :||December 2009|
|Estimated Primary Completion Date :||May 2011|
|Estimated Study Completion Date :||May 2014|
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
- Collection of the R0-Resection rate [ Time Frame: 12 weeks ]after 6 cycles of biweekly FLOT chemotherapy and operation.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01160419
|University of Munich, Klinikum Grosshadern|