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

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00737373

Enrollment

143

Registered

2008-08-19

Start date

2007-08-31

Completion date

2011-03-31

Last updated

2012-09-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adenocarcinoma of the Esophagogastric Junction, Gastric Cancer

Brief 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)

Interventions

DRUGDocetaxel

50mg/m2 qd15

DRUG5-Fluorouracil

2600mg/m2 qd15

DRUGOxaliplatin

85mg/m2 qd15

DRUGfolinic acid

200mg/m2 qd15

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

65 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
response (WHO criteria)	staging every 8 weeks

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 25, 2026