Study Assessing the Effects of Chemotherapy in Advanced Esophagogastric Adenocarcinoma

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.

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02177552

Acronym

SEED

Enrollment

Registered

2014-06-27

Start date

2014-06-30

Completion date

2019-11-30

Last updated

2019-02-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Esophageal Neoplasms, Stomach Neoplasms

Keywords

Esophageal cancer, Gastric cancer

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.

Interventions

DRUGCarboplatin

DRUGDocetaxel

DRUGCapecitabine

DRUGEpirubicin

DRUGOxaliplatin

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 79 Years

Healthy volunteers

Inclusion 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

Design outcomes

Primary

Measure	Time frame
The proportion of participants alive one year after randomisation	Three and a half years

Secondary

Measure	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
The proportion of participants who have carboplatin, docetaxel and capecitabine re-induced	Five years
Registration of further lines of therapy	Five years
Changes in quality-of-life	Three and a half years

Other

Measure	Time frame	Description
Analysis of cmet by immunohistochemistry	Three and a half years	Analysis of archived tumour tissue (primary biopsy, previous surgical resection specimen if available) and metastatic tumour tissue for consenting subjects.

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 22, 2026