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

Phase 2

Completed

• Conditions: Gastric Cancer; Adenocarcinoma of the Esophagogastric Junction
• Interventions: Drug: Docetaxel; Drug: 5-Fluorouracil; Drug: Oxaliplatin; Drug: folinic acid

• Registration Number: NCT00737373
• Lead Sponsor: Krankenhaus Nordwest

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)

Study Timeline

• Study Start: 2007-08
• Study First Submitted: 2008-08-18
• Study First Submitted QC: 2008-08-18
• Study First Posted: 2008-08-19
• Primary Completion: 2009-12
• Study Completion: 2011-03
• Status Verified: 2012-08
• Last Update Submitted: 2012-09-18
• Last Update Posted: 2012-09-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 143

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Docetaxel	FLOT
1	5-Fluorouracil	FLOT
1	Oxaliplatin	FLOT
2	Oxaliplatin	FLO
1	folinic acid	FLOT
2	5-Fluorouracil	FLO
2	folinic acid	FLO

Primary Outcome Measures

Name	Time	Method
response (WHO criteria)	staging every 8 weeks

Trial Locations

Locations (1)

Krankenhaus Nordwest; 🇩🇪 Frankfurt, Germany