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

September 18, 2012 updated by: Krankenhaus Nordwest

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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)

Study Type

Interventional

Enrollment (Actual)

143

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Frankfurt, Germany, 60488
        • Krankenhaus Nordwest

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
response (WHO criteria)
Time Frame: staging every 8 weeks
staging every 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Krankenhaus Nordwest

Investigators

  • Study Chair: Salah Al-Batran, MD, Krankenhaus Nordwest

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2007

Primary Completion (Actual)

December 1, 2009

Study Completion (Actual)

March 1, 2011

Study Registration Dates

First Submitted

August 18, 2008

First Submitted That Met QC Criteria

August 18, 2008

First Posted (Estimate)

August 19, 2008

Study Record Updates

Last Update Posted (Estimate)

September 19, 2012

Last Update Submitted That Met QC Criteria

September 18, 2012

Last Verified

August 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FLOT65+

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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