Study Assessing the Effects of Chemotherapy in Advanced Esophagogastric Adenocarcinoma

Phase 2

• Conditions: Esophageal Neoplasms; Stomach Neoplasms
• Interventions: Drug: Carboplatin; Drug: Docetaxel; Drug: Epirubicin; Drug: Capecitabine; Drug: Oxaliplatin

• Registration Number: NCT02177552
• Lead Sponsor: Rigshospitalet, Denmark

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-06
• Study First Submitted: 2014-06-18
• Study First Submitted QC: 2014-06-25
• Study First Posted: 2014-06-27
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-13
• Last Update Posted: 2019-02-15
• Primary Completion: 2019-08
• Study Completion: 2019-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 98

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental chemotherapy	Carboplatin	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.
Experimental chemotherapy	Docetaxel	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.
Experimental chemotherapy	Capecitabine	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.
Standard chemotherapy	Capecitabine	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
Standard chemotherapy	Epirubicin	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
Standard chemotherapy	Oxaliplatin	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

Primary Outcome Measures

Name	Time	Method
The proportion of participants alive one year after randomisation	Three and a half years

Secondary Outcome Measures

Name	Time	Method
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
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

Trial Locations

Locations (1)

Finsen Center, Rigshospitalet; 🇩🇰 Copenhagen, Denmark