Multicenter Study to Perioperative Chemotherapy for Resectable Adenocarcinoma in Gastric Cancer

Gastric Cancer Clinical Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01160419
• Other study ID #: NEO-FLOT
• Secondary ID: EudraCT Nr.: 200
• Status: Active, not recruiting
• Phase: Phase 2
• First received: October 22, 2009
• Last updated: October 27, 2010
• Start date: December 2009
• Est. completion date: May 2014

Study information

• Verified date: December 2009
• Source: Ludwig-Maximilians - University of Munich
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 49
• Est. completion date: May 2014
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gastric Cancer
• Stomach Neoplasms

Intervention

Drug:
• 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

Locations

Country	Name	City	State
Germany	University of Munich, Klinikum Grosshadern	Munich

Sponsors (2)

Lead Sponsor	Collaborator
Ludwig-Maximilians - University of Munich	Sanofi

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Collection of the R0-Resection rate	after 6 cycles of biweekly FLOT chemotherapy and operation.	12 weeks	No