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

Study Overview
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Brief Summary
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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
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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)

Official Title
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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

Conditions
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Gastric Cancer, Adenocarcinoma of the Esophagogastric Junction

Intervention / Treatment
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* Drug: Docetaxel
* Drug: 5-Fluorouracil
* Drug: Oxaliplatin
* Drug: folinic acid


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>FLOT | Drug: Docetaxel<br>* 50mg/m2 qd15<br>Drug: 5-Fluorouracil<br>* 2600mg/m2 qd15<br>Drug: Oxaliplatin<br>* 85mg/m2 qd15<br>Drug: folinic acid<br>* 200mg/m2 qd15<br>|
| Active Comparator: 2<br>FLO | Drug: 5-Fluorouracil<br>* 2600mg/m2 qd15<br>Drug: Oxaliplatin<br>* 85mg/m2 qd15<br>Drug: folinic acid<br>* 200mg/m2 qd15<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| response (WHO criteria) |  | staging every 8 weeks |