Oxaliplatin and 5-Fluorouracil With or Without Docetaxel in Elderly Patients (>65 y) With Stomach and Esophagus Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Krankenhaus Nordwest
ClinicalTrials.gov Identifier:
NCT00737373
First received: August 18, 2008
Last updated: September 18, 2012
Last verified: August 2012
  Purpose

In this trial, FLOT will be evaluated as therapy option for elderly patients (>65 years) with advanced gastric cancer in comparison to the well established FLO scheme. The hypothesis is that FLOT is more effective than FLO in elderly patients with acceptable side effects.


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: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Multicenter, Randomised Phase II Trial on the Therapy of Advanced Gastric Cancer or Adenocarcinoma of the Esophagogastric Junction in Patients Older Than 65 Years With Specific Regard of Quality of Life and Pharmacogenetic Risk Profile

Resource links provided by NLM:


Further study details as provided by Krankenhaus Nordwest:

Primary Outcome Measures:
  • response (WHO criteria) [ Time Frame: staging every 8 weeks ] [ Designated as safety issue: No ]

Enrollment: 143
Study Start Date: August 2007
Study Completion Date: March 2011
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
FLOT
Drug: Docetaxel
50mg/m2 qd15
Drug: 5-Fluorouracil
2600mg/m2 qd15
Drug: Oxaliplatin
85mg/m2 qd15
Drug: folinic acid
200mg/m2 qd15
Active Comparator: 2
FLO
Drug: 5-Fluorouracil
2600mg/m2 qd15
Drug: Oxaliplatin
85mg/m2 qd15
Drug: folinic acid
200mg/m2 qd15

Detailed Description:

Patients with locally advanced, potentially operable or metastatic gastric cancer or adenocarcinoma of the esophagogastric junction without prior therapy in the palliative setting are treated with:

  • Arm A: FLO
  • Arm B: FLOT

max. 12 cycles

Evaluation of quality of life by standard forms at baseline and then every 2 months until progress of disease. Pharmacogenetic analyses will be done to evaluate a risk profile for platin-based therapies. 140 patients will be treated (70 per arm)

primary endpoint:

  • Response Rate

secondary endpoints:

  • Prospective Validation of a pharmacogenetic risk profile for patients with advanced GC under first-line therapy with platin/docetaxel
  • Evaluation of quality of life
  • safety and tolerability
  • progression free survival (PFS), time to treatment failure (TTF), overall survival (OS)
  Eligibility

Ages Eligible for Study:   65 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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00737373

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

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Krankenhaus Nordwest
ClinicalTrials.gov Identifier: NCT00737373     History of Changes
Other Study ID Numbers: FLOT65+
Study First Received: August 18, 2008
Last Updated: September 18, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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

ClinicalTrials.gov processed this record on August 28, 2014