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

Sponsor

Krankenhaus Nordwest (Other)

Overall Status

Completed

CT.gov ID

NCT00737373

Collaborator

(none)

143

Enrollment

Location

Arms

Duration (Months)

3.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Gastric Cancer Adenocarcinoma of the Esophagogastric Junction	Drug: Docetaxel Drug: 5-Fluorouracil Drug: Oxaliplatin Drug: folinic acid	Phase 2

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 Design

Study Type:

Interventional

Actual Enrollment :

143 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Aug 1, 2007

Actual Primary Completion Date :

Dec 1, 2009

Actual Study Completion Date :

Mar 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 FLOT	Drug: Docetaxel 50mg/m2 qd15 Drug: 5-Fluorouracil 2600mg/m2 qd15 Drug: Oxaliplatin 85mg/m2 qd15 Drug: folinic acid 200mg/m2 qd15
Active Comparator: 2 FLO	Drug: 5-Fluorouracil 2600mg/m2 qd15 Drug: Oxaliplatin 85mg/m2 qd15 Drug: folinic acid 200mg/m2 qd15

Arm

Intervention/Treatment

Experimental: 1

FLOT

Drug: Docetaxel

50mg/m2 qd15

Drug: 5-Fluorouracil

2600mg/m2 qd15

Drug: Oxaliplatin

85mg/m2 qd15

Drug: folinic acid

200mg/m2 qd15

Active Comparator: 2

FLO

Drug: 5-Fluorouracil

2600mg/m2 qd15

Drug: Oxaliplatin

85mg/m2 qd15

Drug: folinic acid

200mg/m2 qd15

Outcome Measures

Primary Outcome Measures

response (WHO criteria) [staging every 8 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

65 Years and Older

Sexes Eligible for Study:

All

Accepts 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