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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 special regard on quality of life and the pharmacogenetic risk profile - FLOT65+

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 special regard on quality of life and the pharmacogenetic risk profile - FLOT65+

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2006-006936-24-DE
Enrollment
108
Registered
2007-05-16
Start date
2007-07-17
Completion date
Unknown
Last updated
2012-03-19

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

Conditions

metastatic or locally advanced gastric cancer or adenocarcinoma of the esophagogastric junction

Interventions

Trade Name: Taxotere 80mg Konzentrat und Lösungsmittel zur Herstellung einer Infusionslösung Product Name: not applicable Product Code: not applicable Pharmaceutical Form: Concentrate for solution for

Sponsors

Krankenhaus Nordwest GmbH
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: metastatic, locally advanced or refractory gastric cancer or adenocarcinoma of the esophagogastric junction no previous chemotherapy in metastatic state patients (male and female) older than 65 years ECOG 0, 1 or 2 Leucocytes > 3000/µl Thrombocytes >100000/µl Creatinine serum level 40 ml/min signed informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Hypersensitivity for 5-Fluorouracil, Leucovorin, Oxaliplatin or Docetaxel KHK, cardiomyopathy or cardiac insufficiency II-IV (NYHA) second malignancy NCI grade II impairment of liver function (AST/AKT>3,5xULN, AP>6xULN, Bilirubin>1,5xULN) chronic intestinal inflammation participation in another clinical trial

Design outcomes

Primary

MeasureTime frame
Primary end point(s): response rate;Main Objective: response rate;Secondary Objective: validation of a pharmacogenetic risk-profile for patients with advanced gastric cancer in platin/docetaxel-containing first-line therapy evaluation of life quality safety and tolerability time to treatment failure time to progression overall survival—

Countries

Germany

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026