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Study Assessing the Effects of Chemotherapy in Advanced Esophagogastric Adenocarcinoma
Conditions
Esophageal Neoplasms - Stomach Neoplasms
Conditions: official terms
Adenocarcinoma - Esophageal Neoplasms - Neoplasms - Stomach Neoplasms
Conditions: Keywords
Esophageal cancer, Gastric cancer
Study Type
Interventional
Study Phase
Phase 2
Study Design
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Carboplatin
Type: Drug
Name: Docetaxel
Type: Drug
Name: Capecitabine
Type: Drug
Name: Epirubicin
Type: Drug
Name: Oxaliplatin
Type: Drug
Overall Status
Recruiting
Summary
The main purpose of this study is to determine the effects of treatment with carboplatin, docetaxel and capecitabine in patients with incurable cancer of the esophagus or stomach.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 75 Years
Minimum Age: 18 Years
Gender: Both
Criteria: Key Inclusion Criteria:
- Patients with histologically verified, unresectable or metastatic, HER2-negative, adenocarcinoma of the esophagus or stomach
- Men or women less than 80 years of age
- Performance status 0 or 1
- Life expectancy >12 weeks
- Adequate organ-function
- Written informed consent
Key Exclusion Criteria:
- Prior chemotherapy for adenocarcinoma of the esophagus or stomach if the chemotherapy-free interval is less than 6 months
- Progression on first-line chemotherapy for unresectable or metastatic adenocarcinoma of the esophagus or stomach
- Chemotherapy with epirubicin, oxaliplatin, carboplatin, cisplatin or docetaxel less than 6 months before study entry
- Prior cumulative dose of >300 mg/m2 of epirubicin
- Grade ≥ 2 side-effects from previous chemotherapy
- Patients with histologically verified, unresectable or metastatic, HER2-negative, adenocarcinoma of the esophagus or stomach
- Men or women less than 80 years of age
- Performance status 0 or 1
- Life expectancy >12 weeks
- Adequate organ-function
- Written informed consent
Key Exclusion Criteria:
- Prior chemotherapy for adenocarcinoma of the esophagus or stomach if the chemotherapy-free interval is less than 6 months
- Progression on first-line chemotherapy for unresectable or metastatic adenocarcinoma of the esophagus or stomach
- Chemotherapy with epirubicin, oxaliplatin, carboplatin, cisplatin or docetaxel less than 6 months before study entry
- Prior cumulative dose of >300 mg/m2 of epirubicin
- Grade ≥ 2 side-effects from previous chemotherapy
Location
Finsen Center, Rigshospitalet
Copenhagen, Denmark
Status: Recruiting
Start Date
June 2014
Completion Date
January 2018
Sponsors
Rigshospitalet, Denmark
Source
Rigshospitalet, Denmark
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
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