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Completed

NCT Number: NCT00737373

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

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.

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Key information

Conditions

Gastric Cancer Adenocarcinoma of the Esophagogastric Junction Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Neoplasms Neoplasms by Site Stomach Diseases Stomach Neoplasms

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Krankenhaus Nordwest

Frankfurt, 60488, Germany

About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

docetaxel

Drug

50mg/m2 qd15

5-fluorouracil

Drug

2600mg/m2 qd15

Oxaliplatin

Drug

85mg/m2 qd15

Folinic acid

Drug

200mg/m2 qd15

Primary outcomes

  1. response (WHO criteria)

    Time frame: staging every 8 weeks

Sponsors and collaborators

Lead sponsor

Krankenhaus Nordwest

Other

Registry information

Official study 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

Important dates

Study start
2007
Primary completion
2009
Study completion
2011
First posted
Aug 19, 2008
Registry last updated
Sep 19, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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