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
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Enrollment
- 143
- Locations
- 1
- Primary Endpoint
- response (WHO criteria)
Study Overview
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:
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 65 Years to — (Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
1
FLOT
Intervention: Docetaxel (Drug)
1
FLOT
Intervention: 5-Fluorouracil (Drug)
1
FLOT
Intervention: Oxaliplatin (Drug)
1
FLOT
Intervention: folinic acid (Drug)
2
FLO
Intervention: 5-Fluorouracil (Drug)
2
FLO
Intervention: Oxaliplatin (Drug)
2
FLO
Intervention: folinic acid (Drug)
Outcomes
Primary Outcomes
response (WHO criteria)
Time Frame: staging every 8 weeks
Secondary Outcomes
No secondary outcomes reported