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Trial Title:
Study Assessing the Effects of Chemotherapy in Advanced Esophagogastric Adenocarcinoma
NCT ID:
NCT02177552
Condition:
Esophageal Neoplasms
Stomach Neoplasms
Conditions: Official terms:
Neoplasms
Adenocarcinoma
Stomach Neoplasms
Esophageal Neoplasms
Carboplatin
Docetaxel
Capecitabine
Oxaliplatin
Epirubicin
Conditions: Keywords:
Esophageal cancer
Gastric cancer
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Unknown status
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Carboplatin
Arm group label:
Experimental chemotherapy
Intervention type:
Drug
Intervention name:
Docetaxel
Arm group label:
Experimental chemotherapy
Intervention type:
Drug
Intervention name:
Capecitabine
Arm group label:
Experimental chemotherapy
Arm group label:
Standard chemotherapy
Intervention type:
Drug
Intervention name:
Epirubicin
Arm group label:
Standard chemotherapy
Intervention type:
Drug
Intervention name:
Oxaliplatin
Arm group label:
Standard chemotherapy
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:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
79 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Finsen Center, Rigshospitalet
Address:
City:
Copenhagen
Zip:
2100
Country:
Denmark
Start date:
June 2014
Completion date:
November 2019
Lead sponsor:
Agency:
Rigshospitalet, Denmark
Agency class:
Other
Source:
Rigshospitalet, Denmark
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT02177552
