Multicenter Study to Perioperative Chemotherapy for Resectable Adenocarcinoma in Gastric Cancer
2 other identifiers
interventional
49
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2 gastric-cancer
Started Dec 2009
Typical duration for phase_2 gastric-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 22, 2009
CompletedStudy Start
First participant enrolled
December 1, 2009
CompletedFirst Posted
Study publicly available on registry
July 12, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2014
CompletedOctober 28, 2010
December 1, 2009
1.4 years
October 22, 2009
October 27, 2010
Conditions
Outcome Measures
Primary Outcomes (1)
Collection of the R0-Resection rate
after 6 cycles of biweekly FLOT chemotherapy and operation.
12 weeks
Study Arms (1)
FLOT
OTHERDocetaxel, Oxaliplatin, Folinic acid, 5-FU, q 2 weeks, application of 6 cycles
Interventions
Eligibility Criteria
You may qualify if:
- 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
- Adequate Hematological, Renal, Cardiac and Hepatic Function
- Effective Contraception
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ludwig-Maximilians - University of Munichlead
- Sanoficollaborator
Study Sites (1)
University of Munich, Klinikum Grosshadern
Munich, Germany
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
October 22, 2009
First Posted
July 12, 2010
Study Start
December 1, 2009
Primary Completion
May 1, 2011
Study Completion
May 1, 2014
Last Updated
October 28, 2010
Record last verified: 2009-12