Study Assessing the Effects of Chemotherapy in Advanced Esophagogastric Adenocarcinoma (SEED)

Rigshospitalet

Status and phase: Unknown; Phase 2

Conditions: Stomach Neoplasms; Esophageal Neoplasms

Treatments: Drug: Oxaliplatin; Drug: Capecitabine; Drug: Docetaxel; Drug: Epirubicin; Drug: Carboplatin

Study type: Interventional

Funder types: Other

Identifiers

NCT02177552

2014-000127-24 (EudraCT Number)

01052014

Details and patient eligibility

About

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.

Enrollment: 98 estimated patients

Sex: All

Ages: 18 to 79 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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98 participants in 2 patient groups

Experimental chemotherapy

Experimental group

Description:

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.

Treatment:

Drug: Carboplatin

Drug: Capecitabine

Drug: Docetaxel

Standard chemotherapy

Other group

Description:

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

Treatment:

Drug: Oxaliplatin

Drug: Capecitabine

Drug: Epirubicin