NCT00675194

Brief Summary

The purpose of this study is to determine which Arm (capecitabine + irinotecan versus capecitabine + cisplatin) shows higher response rates in the treatment of advanced gastric-oesophagal cancer Furthermore, comparison of progression-free survival, 1-year survival, Quality of Life and safety

Trial Health

87
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P75+ for phase_2 gastric-cancer

Timeline
Completed

Started Oct 2003

Typical duration for phase_2 gastric-cancer

Geographic Reach
1 country

1 active site

Status
completed

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

October 1, 2003

Completed
4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2007

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

May 6, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 8, 2008

Completed
Last Updated

May 20, 2008

Status Verified

May 1, 2008

First QC Date

May 6, 2008

Last Update Submit

May 16, 2008

Conditions

Gastric Cancer

Keywords

cisplatincapecitabinegastricirinotecanmetastaticchemotherapy

Outcome Measures

Primary Outcomes (1)

  • response rate

Secondary Outcomes (5)

  • safety

  • progression free survival

  • 1 year survival

  • Quality of Life

  • Analysis of the dose and efficacy of Epoetin beta weekly in anaemic patients

Interventions

Cisplatin, Irinotecan, CapecitabineDRUG

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • gastric or gastric-oesophagal junction adenocarcinoma
  • unidimensional measurable disease
  • Karnofsky index \>/=60%

You may not qualify if:

  • prior chemo- or radiotherapy
  • colorectal diseases
  • brain metastases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Johannes Gutenberg Universität , I. Medizinische Klinik und Polokilinik

Mainz, 55101, Germany

Location

MeSH Terms

Conditions

Stomach NeoplasmsNeoplasm Metastasis

Interventions

CisplatinIrinotecanCapecitabine

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach DiseasesNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Chlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum CompoundsCamptothecinAlkaloidsHeterocyclic CompoundsDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingFluorouracilUracilPyrimidinonesDeoxyribonucleosidesNucleosidesNucleic Acids, Nucleotides, and Nucleosides

Study Officials

  • Markus Moehler, MD

    Johannes Gutenberg University Mainz

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 6, 2008

First Posted

May 8, 2008

Study Start

October 1, 2003

Study Completion

October 1, 2007

Last Updated

May 20, 2008

Record last verified: 2008-05

Locations

DE(1)