Colorectal CancerPhase 3NCT00189683
Xeloda Vs Monitoring in Advanced Colorectal Cancer Responsive to Chemotherapy
A Phase 3 study testing Monitoring and Xeloda in people with Colorectal Cancer, run by Association Européenne de Recherche en Oncologie at 1 site in France.
Trial summary
To compare maintenance chemotherapy with Xeloda to control after best response with first line chemotherapy in advanced colorectal cancer. Main endpoint is progression free survival. A total of 300 patients will be included. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Monitoring and Xeloda
- Type of treatment
- Surgery or procedure
- How many people
- Not given
- Where
- 1 siteFrance
- Study dates
- Start not givento not given
- Phase
- Phase 3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with metastatic colorectal cancer (confirmed histologically) with objective response or stabilization after at least 6 cycles of first line chemotherapy (treatment of choice is selected freely by the investigator according to the recommendations and consensus in force),
- The interval between completion of first line chemotherapy and randomization should not exceed 4 weeks
- Age>18 years
- ECOG status 0 to 2
- Biological criteria prior to any chemotherapy:
- Neutrophils>1.5 109 g/l, platelets>100 109/l, haemoglobin>10 g/dl, Creatininaemia<150 mol/l, bilirubinaemia<2x normal level
- Signed informed consent
- Life expectancy > 3 months
Who cannot join
- Metastatic colorectal cancer treated with more than one modality of first line chemotherapy (including oral fluoropyrimidines)
- Tumour progression after first line chemotherapy or before randomization
- Other tumour pathology
- Symptomatic cerebral metastases
- Any severe uncontrolled disease in addition to colorectal cancer (in particular decompensated cardiac failure (LVEF<50%) or coronary insufficiency)
- Lack of integrity of the upper GI tract: malabsorption syndrome or major surgery of the stomach or the small intestine
Show all 10Show fewer
- Severe renal impairment (creatinine clearance < 30 ml/min)
- Severe psychiatric disorder (other than controlled depressive syndrome)
- Patient participating in another experiment
- Pregnant women
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
AERO
Créteil, 94000
Elizabeth Fabre-Guillevin, MD, + 33 1 43 77 72 10, elizabeth.fabre-guillevin@egp.aphp.fr
About this study
To compare maintenance chemotherapy with Xeloda to control after best response with first line chemotherapy in advanced colorectal cancer. Main endpoint is progression free survival. A total of 300 patients will be included.
- Conditions
- Colorectal Cancer
- Being tested
- Monitoring, Xeloda
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MonitoringProcedure or surgery
XelodaProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2005 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- Association Européenne de Recherche en Oncologie
- Sponsor type
- University, hospital or other
- Collaborators
- Roche Pharma AG
- Investigators
- Elizabeth Fabre-Guillevin, MD, Principal investigator, AEROEric Van Cutsem, MD, Principal investigator, BGDOMarc Polus, MD, Principal investigator, BGDO
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00189683
- Sponsor's protocol ID
- AERO-MC04
- Status last verified
- Sep 2005
- First submitted
- 12 Sep 2005
- Last updated
- 19 Sep 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Xeloda Vs Monitoring in Advanced Colorectal Cancer Responsive to Chemotherapy
- ClinicalTrials.gov ID
- NCT00189683
- Acronym / sponsor ID
- AERO-MC04
- Conditions
- Colorectal Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Lead sponsor
- Association Européenne de Recherche en OncologieUniversity, hospital or other
- Collaborators
- Roche Pharma AG
- First posted
- 19 Sep 2005 (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.
To compare maintenance chemotherapy with Xeloda to control after best response with first line chemotherapy in advanced colorectal cancer. Main endpoint is progression free survival. A total of 300 patients will be included.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patients with metastatic colorectal cancer (confirmed histologically) with objective response or stabilization after at least 6 cycles of first line chemotherapy (treatment of choice is selected freely by the investigator according to the recommendations and consensus in force),
- The interval between completion of first line chemotherapy and randomization should not exceed 4 weeks
- Age>18 years
- ECOG status 0 to 2
- Biological criteria prior to any chemotherapy:
Key exclusion criteria (10 listed)
- Metastatic colorectal cancer treated with more than one modality of first line chemotherapy (including oral fluoropyrimidines)
- Tumour progression after first line chemotherapy or before randomization
- Other tumour pathology
- Symptomatic cerebral metastases
- Any severe uncontrolled disease in addition to colorectal cancer (in particular decompensated cardiac failure (LVEF<50%) or coronary insufficiency)
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 |
|---|---|---|
| Monitoring | Procedure or surgery | – |
| Xeloda | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2005.
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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.
Elizabeth Fabre-Guillevin, MD principal investigator
AERO
Eric Van Cutsem, MD principal investigator
BGDO
Marc Polus, MD principal investigator
BGDO
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Monitoring and Xeloda in people with Colorectal Cancer, run by Association Européenne de Recherche en Oncologie at 1 site in France.
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 8 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 19 Sep 2005. 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 France. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Annie Jouhaud (+ 33 1 43 77 72 10, annie.jouhaud@aero-eu.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
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 19 Sep 2005.