Overview

This trial is active, not recruiting.

Condition gastric cancer
Treatments docetaxel 50 mg/m2, 1-hour-infusion, day 1, oxaliplatin 85 mg/m², 2-hour-infusion, day 1, folinic acid 200 mg/m², 1-2-hour-infusion, day 1, 5-fu 2600 mg/m², 24-hour-infusion, day 1
Phase phase 2
Sponsor Ludwig-Maximilians - University of Munich
Collaborator Sanofi
Start date December 2009
End date May 2011
Trial size 49 participants
Trial identifier NCT01160419, EudraCT Nr.: 2008-007546-56, NEO-FLOT

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Other)
Docetaxel, Oxaliplatin, Folinic acid, 5-FU, q 2 weeks, application of 6 cycles
docetaxel 50 mg/m2, 1-hour-infusion, day 1
50 mg/m2, 1-hour-Infusion, day 1
oxaliplatin 85 mg/m², 2-hour-infusion, day 1
85 mg/m², 2-hour-Infusion, day 1
folinic acid 200 mg/m², 1-2-hour-infusion, day 1
200 mg/m², 1-2-hour-Infusion, day 1
5-fu 2600 mg/m², 24-hour-infusion, day 1
2600 mg/m², 24-hour-Infusion, day 1

Primary Outcomes

Measure
Collection of the R0-Resection rate
time frame: 12 weeks

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Histologically Confirmed Adenocarcinoma of the Gastroesophageal Junction (AEG I-III) or Gastric Adenocarcinoma (every T, N+ or T3/T4, Nx, M0) - Written Informed Consent - Age ≥ 18 Years - Expected operability - ECOG ≤ 2 - Exclusion of Peritoneal Metastasis - Adequate Hematological, Renal, Cardiac and Hepatic Function - Effective Contraception Exclusion Criteria: - Prior Chemotherapy or Radiotherapy of the Adenocarcinoma of the Gastroesophageal Junction (AEG I-III) or Gastric Adenocarcinoma - Not Histologically Confirmed Primary Tumor - Distant Metastasis, Local Relapse - Known Hypersensitivity for 5-Fluorouracil, Leucovorin, Oxaliplatin or Docetaxel - Known Dihydropyrimidin-Dehydrogenase (DPD) - Deficiency - Peripheral Polyneuropathy ≥ Grade II (NCI-CTCAE, Version 3.0) - Myocardial Infarction in the last 3 Months, Cardiac Insufficiency Grade II-IV (NYHA) - Severe Comorbidity or Acute Infections - Pregnancy or Breast Feeding - Insufficient Contraception - Participation in another Clinical Trial (Simultaneously or 30 Days Prior to Enrollment) - Malignancy <5 years (except: Carcinoma In Situ of the Cervix Uteri or Adequately Treated Basalioma of the Skin) - Lack of Legal Capacity

Trial information was received from ClinicalTrials.gov and was last updated in October 2010.
Information provided to ClinicalTrials.gov by Ludwig-Maximilians - University of Munich.