NCT02177552

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
98

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jun 2014

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2014

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

June 18, 2014

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 27, 2014

Completed
5.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2019

Completed
Last Updated

February 15, 2019

Status Verified

February 1, 2019

Enrollment Period

5.2 years

First QC Date

June 18, 2014

Last Update Submit

February 13, 2019

Conditions

Esophageal NeoplasmsStomach Neoplasms

Keywords

Esophageal cancerGastric cancer

Outcome Measures

Primary Outcomes (1)

  • The proportion of participants alive one year after randomisation

    Three and a half years

Secondary Outcomes (6)

  • 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

  • +1 more secondary outcomes

Other Outcomes (1)

  • Analysis of cmet by immunohistochemistry

    Three and a half years

Study Arms (2)

Experimental chemotherapy

EXPERIMENTAL

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: CarboplatinDrug: DocetaxelDrug: Capecitabine

Standard chemotherapy

OTHER

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: CapecitabineDrug: EpirubicinDrug: Oxaliplatin

Interventions

CarboplatinDRUG
Experimental chemotherapy
DocetaxelDRUG
Experimental chemotherapy
CapecitabineDRUG
Experimental chemotherapyStandard chemotherapy
EpirubicinDRUG
Standard chemotherapy
OxaliplatinDRUG
Standard chemotherapy

Eligibility Criteria

Age18 Years - 79 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Finsen Center, Rigshospitalet

Copenhagen, 2100, Denmark

Location

Related Publications (1)

  • 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.

    PMID: 34086514DERIVED

MeSH Terms

Conditions

Esophageal NeoplasmsStomach Neoplasms

Interventions

CarboplatinDocetaxelCapecitabineEpirubicinOxaliplatin

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsDigestive System DiseasesEsophageal DiseasesGastrointestinal DiseasesStomach Diseases

Intervention Hierarchy (Ancestors)

Coordination ComplexesOrganic ChemicalsTaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsDiterpenesTerpenesDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsFluorouracilUracilPyrimidinonesDeoxyribonucleosidesNucleosidesNucleic Acids, Nucleotides, and NucleosidesDoxorubicinDaunorubicinAnthracyclinesNaphthacenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticPolycyclic CompoundsAminoglycosidesGlycosidesCarbohydrates

Study Officials

  • Peter C Petersen, MD

    Finsen Center, Rigshospitalet

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

June 18, 2014

First Posted

June 27, 2014

Study Start

June 1, 2014

Primary Completion

August 1, 2019

Study Completion

November 1, 2019

Last Updated

February 15, 2019

Record last verified: 2019-02

Locations

DK(1)