Study Assessing the Effects of Chemotherapy in Advanced Esophagogastric Adenocarcinoma

Study Overview
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Brief Summary
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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.

Official Title
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Study Assessing the Effects of Chemotherapy in Advanced Esophagogastric Adenocarcinoma - Carboplatin, Docetaxel and Capecitabine (CTX) or Epirubicin, Oxaliplatin and Capecitabine: a Randomised Phase 2 Trial.

Conditions
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Esophageal Neoplasms, Stomach Neoplasms

Intervention / Treatment
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* Drug: Carboplatin
* Drug: Docetaxel
* Drug: Capecitabine
* Drug: Epirubicin
* Drug: Oxaliplatin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 79 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental chemotherapy<br>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. | Drug: Carboplatin<br> <br> Drug: Docetaxel<br> <br> Drug: Capecitabine<br> <br> |
| Other: Standard chemotherapy<br>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 | Drug: Capecitabine<br> <br> Drug: Epirubicin<br> <br> Drug: Oxaliplatin<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The proportion of participants alive one year after randomisation |  | Three and a half years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to progression or death due to any cause |  | Three and a half years | 
| Number of participants with grade 3 and 4 toxicities caused by treatments |  | Day 1 of every cycle and 30 days after completion of treatment | 
| Time until death due to any cause |  | Three and a half years | 
| Changes in quality-of-life |  | Three and a half years | 
| The proportion of participants who have carboplatin, docetaxel and capecitabine re-induced |  | Five years | 
| Registration of further lines of therapy |  | Five years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Esophageal cancer, Gastric cancer