Overview

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

Status:
Completed
Trial end date:
2011-03-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Krankenhaus Nordwest
Treatments:
Docetaxel
Fluorouracil
Folic Acid
Leucovorin
Levoleucovorin
Oxaliplatin
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