Multicenter Study to Perioperative Chemotherapy for Resectable Adenocarcinoma in Gastric Cancer

Study Overview
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Brief Summary
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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
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Gastric Cancer

Intervention / Treatment
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* 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


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: FLOT<br>Docetaxel, Oxaliplatin, Folinic acid, 5-FU, q 2 weeks, application of 6 cycles | Drug: Docetaxel 50 mg/m2, 1-hour-Infusion, day 1<br>* 50 mg/m2, 1-hour-Infusion, day 1<br>Drug: Oxaliplatin 85 mg/m², 2-hour-Infusion, day 1<br>* 85 mg/m², 2-hour-Infusion, day 1<br>Drug: Folinic acid 200 mg/m², 1-2-hour-Infusion, day 1<br>* 200 mg/m², 1-2-hour-Infusion, day 1<br>Drug: 5-FU 2600 mg/m², 24-hour-Infusion, day 1<br>* 2600 mg/m², 24-hour-Infusion, day 1<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Collection of the R0-Resection rate | after 6 cycles of biweekly FLOT chemotherapy and operation. | 12 weeks |