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Phase 2
18 Years
N/A
Open (Enrolling)
Both
Gastric Cancer

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Trial Information


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Collection of the R0-Resection rate

Outcome Description:

after 6 cycles of biweekly FLOT chemotherapy and operation.

Outcome Time Frame:

12 weeks

Safety Issue:

No

Authority:

Germany: Federal Institute for Drugs and Medical Devices

Study ID:

NEO-FLOT

NCT ID:

NCT01160419

Start Date:

December 2009

Completion Date:

May 2014

Related Keywords:

  • Gastric Cancer
  • Stomach Neoplasms

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