Multicenter Study to Perioperative Chemotherapy for Resectable Adenocarcinoma in Gastric Cancer

Phase 2

• Conditions: Gastric Cancer
• Interventions: 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

• Registration Number: NCT01160419
• Lead Sponsor: Ludwig-Maximilians - University of Munich

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-10-22
• Status Verified: 2009-12
• Study Start: 2009-12
• Study First Submitted QC: 2010-07-09
• Study First Posted: 2010-07-12
• Last Update Submitted: 2010-10-27
• Last Update Posted: 2010-10-28
• Primary Completion: 2011-05
• Study Completion: 2014-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 49

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
FLOT	Oxaliplatin 85 mg/m², 2-hour-Infusion, day 1	Docetaxel, Oxaliplatin, Folinic acid, 5-FU, q 2 weeks, application of 6 cycles
FLOT	Docetaxel 50 mg/m2, 1-hour-Infusion, day 1	Docetaxel, Oxaliplatin, Folinic acid, 5-FU, q 2 weeks, application of 6 cycles
FLOT	Folinic acid 200 mg/m², 1-2-hour-Infusion, day 1	Docetaxel, Oxaliplatin, Folinic acid, 5-FU, q 2 weeks, application of 6 cycles
FLOT	5-FU 2600 mg/m², 24-hour-Infusion, day 1	Docetaxel, Oxaliplatin, Folinic acid, 5-FU, q 2 weeks, application of 6 cycles

Primary Outcome Measures

Name	Time	Method
Collection of the R0-Resection rate	12 weeks	after 6 cycles of biweekly FLOT chemotherapy and operation.

Trial Locations

Locations (1)

University of Munich, Klinikum Grosshadern; 🇩🇪 Munich, Germany