Multicenter Study to Perioperative Chemotherapy for Resectable Adenocarcinoma in Gastric Cancer

Ludwig Maximilian University of Munich

Status and phase: Unknown; Phase 2

Conditions: Gastric Cancer

Treatments: Drug: Folinic acid 200 mg/m², 1-2-hour-Infusion, day 1; Drug: Oxaliplatin 85 mg/m², 2-hour-Infusion, day 1; Drug: Docetaxel 50 mg/m2, 1-hour-Infusion, day 1; Drug: 5-FU 2600 mg/m², 24-hour-Infusion, day 1

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01160419

NEO-FLOT

EudraCT Nr.: 2008-007546-56

Details and patient eligibility

About

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.

Enrollment: 49 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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49 participants in 1 patient group

FLOT

Other group

Description:

Docetaxel, Oxaliplatin, Folinic acid, 5-FU, q 2 weeks, application of 6 cycles

Treatment:

Drug: 5-FU 2600 mg/m², 24-hour-Infusion, day 1

Drug: Oxaliplatin 85 mg/m², 2-hour-Infusion, day 1

Drug: Docetaxel 50 mg/m2, 1-hour-Infusion, day 1

Drug: Folinic acid 200 mg/m², 1-2-hour-Infusion, day 1