EUCTR2014-000127-24-DK
Active, not recruiting
Phase 1
Study assessing the effects of chemotherapy in advanced esophagogastric adenocarcinoma - SEED
Rigshospitalet, Department of Oncology0 sites98 target enrollmentFebruary 27, 2014
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Esophagogastric adenocarcinoma
- Sponsor
- Rigshospitalet, Department of Oncology
- Enrollment
- 98
- Status
- Active, not recruiting
- Last Updated
- 5 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients with histologically verified, unresectable or metastatic, HER2\-negative, adenocarcinoma of the esophagus or stomach.
- •Patients with initially unresectable or metastatic disease, who, after a period of chemotherapy, are to be considered for surgery with curative intent, are eligible.
- •Men or women less than 80 years of age.
- •Performance status 0 or 1\.
- •Life expectancy \>12 weeks.
- •Adequate organ\-function:
- •Renal function: Calculated creatinine clearance \> 60 ml/min by Cockcroft\-Gault equation.
- •Hepatic function: ALAT \< 2\.5 x ULN and alkaline phosphatase \< 5 x ULN and bilirubin Haematology blood counts: Leucocytes \>/\=3 x 109/l, platelets \>/\=100 x 109/l.
- •Cardiac function: NYHA class \< II
- •Patients must be able to take capecitabine tablets whole, or dissolved in water.
Exclusion Criteria
- •Prior chemotherapy for adenocarcinoma of the oesphagus or stomach if the chemotherapy\-free interval is less than 6 months (prior concurrent hemoradiotherapy with curative intent less than 6 months before study entry is allowed)
- •Progression on first\-line chemotherapy for unresectable or metastatic adenocarcinoma of the oesphagus or stomach.
- •Chemotherapy with epirubicin, oxaliplatin, carboplatin, cisplatin or docetaxel less than 6 months before study entry (prior concurrent chemoradiotherapy with curative intent less than 6 months before study entry is allowed)
- •Prior cumulative dose of \>300 mg/m2 of epirubicin
- •Grade \= 2 or more side\-effects from previous chemotherapy.
- •Inability to read and understand written Danish
- •Concurrent prescription anti\-neoplastic systemic therapy
- •Another active cancer that would normally preclude chemotherapy for esophago\-gastric adenocarcinoma
- •Patients with known allergies to any of the drugs administered in this study
- •Patients who are pregnant or breast\-feeding, or might become pregnant within 6 months after the last dose of protocol\-required therapy.
Outcomes
Primary Outcomes
Not specified
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