NCT00737373

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 143 (actual)
• Sponsor: Krankenhaus Nordwest · Academic / Other
• Sex: All
• Age: 65 Years
• Healthy volunteers: Not accepted

Summary

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.

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)

Conditions

• Gastric Cancer
• Adenocarcinoma of the Esophagogastric Junction

Interventions

Type	Name	Description
DRUG	Docetaxel	50mg/m2 qd15
DRUG	5-Fluorouracil	2600mg/m2 qd15
DRUG	Oxaliplatin	85mg/m2 qd15
DRUG	folinic acid	200mg/m2 qd15

Timeline

• Start date: 2007-08-01
• Primary completion: 2009-12-01
• Completion: 2011-03-01
• First posted: 2008-08-19
• Last updated: 2012-09-19

Locations

1 site across 1 country: Germany