Study Assessing the Effects of Chemotherapy in Advanced Esophagogastric Adenocarcinoma
NCT ID: NCT02177552
Last Updated: 2019-02-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
98 participants
INTERVENTIONAL
2014-06-30
2019-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Experimental chemotherapy
Intravenous carboplatin (C) AUC5 day 1 plus intravenous docetaxel (T) 60 mg/m2 day 1 plus oral capecitabine (X) 1000 mg/m2 twice daily from day 1-14, every 4 weeks.
Carboplatin
Docetaxel
Capecitabine
Standard chemotherapy
Intravenous epirubicin (E) 50 mg/m2 day 1 plus intravenous oxaliplatin (O) 130 mg/m2 day 1 plus oral capecitabine (X) 625 mg/m2 twice daily continuously, every 3 weeks
Capecitabine
Epirubicin
Oxaliplatin
Interventions
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Carboplatin
Docetaxel
Capecitabine
Epirubicin
Oxaliplatin
Eligibility Criteria
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Inclusion Criteria
* Men or women less than 80 years of age
* Performance status 0 or 1
* Life expectancy \>12 weeks
* Adequate organ-function
* Written informed consent
Exclusion Criteria
* 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
18 Years
79 Years
ALL
No
Sponsors
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Rigshospitalet, Denmark
OTHER
Responsible Party
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Peter Clausager Petersen
MD
Principal Investigators
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Peter C Petersen, MD
Role: PRINCIPAL_INVESTIGATOR
Finsen Center, Rigshospitalet
Locations
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Finsen Center, Rigshospitalet
Copenhagen, , Denmark
Countries
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References
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Petersen PC, Petersen LN, Vogelius I, Bjerregaard JK, Baeksgaard L. A randomized phase 2 trial of first-line docetaxel, carboplatin, capecitabine (CTX) and epirubicin, oxaliplatin, capecitabine (EOX) in advanced esophagogastric adenocarcinoma. Acta Oncol. 2021 Jul;60(7):948-953. doi: 10.1080/0284186X.2021.1928281. Epub 2021 Jun 4.
Other Identifiers
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2014-000127-24
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
01052014
Identifier Type: -
Identifier Source: org_study_id
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