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

Krankenhaus Nordwest

Status and phase: Completed; Phase 2

Conditions: Gastric Cancer; Adenocarcinoma of the Esophagogastric Junction

Treatments: Drug: folinic acid; Drug: Oxaliplatin; Drug: 5-Fluorouracil; Drug: Docetaxel

Study type: Interventional

Funder types: Other

Identifiers

NCT00737373

FLOT65+

Details and patient eligibility

About

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.

Full 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)

Enrollment: 143 patients

Sex: All

Ages: 65+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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143 participants in 2 patient groups

1

Experimental group

Description:

FLOT

Treatment:

Drug: 5-Fluorouracil

Drug: folinic acid

Drug: Oxaliplatin

Drug: Docetaxel

2

Active Comparator group

Description:

FLO

Treatment:

Drug: 5-Fluorouracil

Drug: folinic acid

Drug: Oxaliplatin