Multicenter Study to Perioperative Chemotherapy for Resectable Adenocarcinoma in Gastric Cancer

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01160419

Enrollment

Registered

2010-07-12

Start date

2009-12-31

Completion date

2014-05-31

Last updated

2010-10-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastric Cancer

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.

Interventions

DRUGDocetaxel 50 mg/m2, 1-hour-Infusion, day 1

50 mg/m2, 1-hour-Infusion, day 1

DRUGOxaliplatin 85 mg/m², 2-hour-Infusion, day 1

85 mg/m², 2-hour-Infusion, day 1

DRUGFolinic acid 200 mg/m², 1-2-hour-Infusion, day 1

200 mg/m², 1-2-hour-Infusion, day 1

DRUG5-FU 2600 mg/m², 24-hour-Infusion, day 1

2600 mg/m², 24-hour-Infusion, day 1

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

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

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026