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Prospective Study With FLOT in Patients With Locally Advanced, Limited Metastatic or Extensive Metastatic Adenocarcinoma of the Stomach or Esophagogastric Junction (FLOT3)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Krankenhaus Nordwest
ClinicalTrials.gov Identifier:
NCT00849615
First received: February 23, 2009
Last updated: July 18, 2013
Last verified: July 2013
  Purpose

Patients with locally advanced or metastatic gastric carcinoma or carcinoma of the esophagogastric junction without prior palliative therapy will be treated with 8 cycles of the FLOT scheme (up to 12 cycles if the response is favourable). Prior to enrollment a unique and detailed clinical evaluation of the dissemination of the disease will be done which includes a differentiated regard of the metastatic status. patients will be classified as having either (A) locally advanced, (B) limited metastatic, or (C) extensive metastatic disease. In arms A and B surgical intervention is planned if operability is reached. The hypothesis is that by classifying patients more individually by the state of their disease, patients in arm B will have a significantly prolonged overall survival compared to patients in arm C.


Condition Intervention Phase
Gastric Cancer
Adenocarcinoma of the Esophagogastric Junction
Drug: Docetaxel
Drug: 5-Fluorouracil
Drug: Oxaliplatin
Drug: folinic acid
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Prospective Multicenter Study With 5-FU, Leucovorin, Oxaliplatin and Docetaxel (FLOT) in Patients With Locally Advanced, Limited Metastatic or Extensive Metastatic Adenocarcinoma of the Stomach or Esophagogastric Junction

Resource links provided by NLM:


Further study details as provided by Krankenhaus Nordwest:

Primary Outcome Measures:
  • overall survival [ Time Frame: every 2 weeks during study, every 3 months follow-up ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pharmacogenetic risk profile [ Time Frame: once at beginning ] [ Designated as safety issue: No ]
  • Quality of Life [ Time Frame: every 8 weeks ] [ Designated as safety issue: No ]
  • Progression free survival (PFS) and response rate (Stratum B and C) [ Time Frame: every 8 weeks ] [ Designated as safety issue: No ]
  • rate of R0-resections, rate of pathological remissions and perioperative morbidity and mortality in stratum A and B Perioperative Morbidität und Mortalität in dem Arm A und ggf. B [ Time Frame: after surgical intervention ] [ Designated as safety issue: No ]

Estimated Enrollment: 250
Study Start Date: February 2009
Estimated Study Completion Date: August 2013
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: FLOT Drug: Docetaxel
50mg/m2 qd15
Drug: 5-Fluorouracil
2600mg/m2 qd15
Drug: Oxaliplatin
85mg/m2 qd15
Drug: folinic acid
200mg/m2 qd15

Detailed Description:

250 patients with locally advanced or metastatic gastric carcinoma or carcinoma of the esophagogastric junction without prior palliative therapy will be treated with 8 cycles of the FLOT scheme (up to 12 cycles if the response is favourable). Prior to enrolment a unique and detailed clinical evaluation of the dissemination of the disease will be done which includes a differentiated regard of the M-category in the TNM classification. A prospective stratification will classify the patients as having either (A) locally advanced, (B) limited metastatic, or (C) extensive metastatic disease. In addition, the pharmacogenetic risk profile of the patients will be evaluated by a combined analysis of two genetic polymorphisms of the metabolism of the applied substances (XPD312, GSTT1). For the assessment of the disease, reference regions are examined by CT or MRI scans and if applicable endoscopy prior to the start of the study, every 2 months during and after the end of therapy until progression of the disease occurs. Evaluation of quality of life (by standard forms like EORTC-Q30 and others) is continued after progression. Clinical examinations (blood count, assessment of toxicity, anamnesis) is performed every two weeks for evaluation of toxicity and application of chemotherapy. After informed consent is given, peripheral blood of the patient will be analysed for the pharmacogenetic risk profile. Representative tumor material will be analysed by immunohistochemistry and quantitative PCR for the expression of several molecular factors.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Metastatic or locally advanced gastric cancer or adenocarcinoma of the esophagogastric junction
  • No prior chemotherapy in metastatic state
  • Adequate blood and biochemistry parameters

Exclusion Criteria:

  • Hypersensitivity for 5-FU, Leucovorin, Oxaliplatin or Docetaxel
  • KHK, cardiomyopathy or cardiac insufficiency
  • Malignancy <5 years ago
  • Brain metastases
  • Severe internal disease or inadequate blood and biochemistry parameters
  • Pregnancy and lactation
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00849615

Locations
Germany
Krankenhaus Nordwest
Frankfurt, Germany, 60488
Sponsors and Collaborators
Krankenhaus Nordwest
Investigators
Study Chair: Salah Al-Batan, MD Krankenhaus Nordwest
  More Information

Publications:
Responsible Party: Krankenhaus Nordwest
ClinicalTrials.gov Identifier: NCT00849615     History of Changes
Other Study ID Numbers: S396 FLOT3
Study First Received: February 23, 2009
Last Updated: July 18, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Adenocarcinoma
Esophageal Neoplasms
Stomach Neoplasms
Carcinoma
Digestive System Diseases
Digestive System Neoplasms
Esophageal Diseases
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Head and Neck Neoplasms
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Stomach Diseases
Docetaxel
Fluorouracil
Oxaliplatin
Antimetabolites
Antimetabolites, Antineoplastic
Antimitotic Agents
Antineoplastic Agents
Immunologic Factors
Immunosuppressive Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses
Tubulin Modulators

ClinicalTrials.gov processed this record on November 19, 2014