Gastric CancerPhase 2NCT00675194
Efficacy of Irinotecan and Capecitabine Versus(vs) Cisplatin and Capecitabine in Patients With Esophago-Gastric Cancer
A Phase 2 study testing Cisplatin, Irinotecan, Capecitabine in people with Gastric Cancer, run by Johannes Gutenberg University Mainz at 1 site in Germany.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Gastric Cancer
- What is being tested?
- Cisplatin, Irinotecan, Capecitabine
- How many people
- 120 participants
- Where
- 1 siteGermany
- Study dates
- Oct 2003to Oct 2007
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- gastric or gastric-oesophagal junction adenocarcinoma
- unidimensional measurable disease
- Karnofsky index >/=60%
Who cannot join
- prior chemo- or radiotherapy
- colorectal diseases
- brain metastases
Trial locations and contacts
1 site in 1 country.
Germany1 site
Johannes Gutenberg Universität , I. Medizinische Klinik und Polokilinik
Mainz, 55101
About this study
Official title: A Prospective, Open, Comparative Multicentre Phase II Study for the Evaluation of Irinotecan and Capecitabine Versus Cisplatin and Capecitabine in Advanced Gastric Adenocarcinoma or Gastric-Oesophagal Junction
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
Read the detailed description
capecitabine + irinotecan versus capecitabine + cisplatin, as published by Kang et al. (ASCO 2006)
- Conditions
- Gastric Cancer
- Being tested
- Cisplatin, Irinotecan, Capecitabine
- Keywords
- cisplatin, capecitabine, gastric, irinotecan, metastatic, chemotherapy
- Medical subject headings
- Stomach Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cisplatin, Irinotecan, CapecitabineDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2008 (estimated)
- Study startOct 2003
- Study completionOct 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johannes Gutenberg University Mainz
- Sponsor type
- University, hospital or other
- Investigators
- Markus Moehler, MD, Principal investigator, Johannes Gutenberg University Mainz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00675194
- Sponsor's protocol ID
- GC-ICE-2003
- Status last verified
- May 2008
- First submitted
- 6 May 2008
- Last updated
- 20 May 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Open, Comparative Multicentre Phase II Study for the Evaluation of Irinotecan and Capecitabine Versus Cisplatin and Capecitabine in Advanced Gastric Adenocarcinoma or Gastric-Oesophagal Junction
- ClinicalTrials.gov ID
- NCT00675194
- Acronym / sponsor ID
- GC-ICE-2003
- Conditions
- Gastric Cancer
- Keywords
- cisplatin, capecitabine, gastric, irinotecan, metastatic, chemotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Johannes Gutenberg University MainzUniversity, hospital or other
- Study start
- Oct 2003
- Study completion
- Oct 2007 (actual)
- First posted
- 8 May 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
capecitabine + irinotecan versus capecitabine + cisplatin, as published by Kang et al. (ASCO 2006)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- gastric or gastric-oesophagal junction adenocarcinoma
- unidimensional measurable disease
- Karnofsky index >/=60%
Key exclusion criteria (3 listed)
- prior chemo- or radiotherapy
- colorectal diseases
- brain metastases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cisplatin, Irinotecan, Capecitabine | Drug | – |
Primary outcome
response rate
5 secondary outcomes
safety
progression free survival
1 year survival
Quality of Life
Analysis of the dose and efficacy of Epoetin beta weekly in anaemic patients
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Markus Moehler, MD principal investigator
Johannes Gutenberg University Mainz
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cisplatin, Irinotecan, Capecitabine in people with Gastric Cancer, run by Johannes Gutenberg University Mainz at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 May 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
response rate. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2008.