Colorectal CancerPhase 3COLOCROSSNCT00905047
Xeloda or UFT (Tegafur-uracil) With Folinic Acid in Advanced or Metastatic Colorectal Cancer
A Phase 3 study testing XELODA and TEGAFUR URACIL - FOLINIC ACID in people with Colorectal Cancer, run by Centre Oscar Lambret at 13 sites in France.
Trial summary
The scope of the trial is to determine the preference of patients, after randomization and cross-over, for one of the two treatments. Another objective of the trial is to assess and compare the safety of each treatment. 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?
- XELODA and TEGAFUR URACIL - FOLINIC ACID
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 89 participants
- Where
- 13 sitesFrance
- Study dates
- 14 Nov 2005to Sep 2011
- 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
- Locally advanced or metastatic colo-rectal cancer
- Age > or = 18 years old
- PS-WHO < or = 2
- Polynuclear neutrophil leukocytes > or = 1500/mm3, platelets > or = 100000/mm3
- Total bilirubin < or = 3 ULN, ASAT-ALAT < or = 2.5 ULN
- Effective contraception
- Written informed consent signed
Who cannot join
- Concomitant radiotherapy
- Contraindication to fluoropyrimidines
- Treatment with sorivudine and its chemical analogs such as brivudine
- Severe hepatic insufficiency
- Severe renal insufficiency
- Pregnant or lactating woman
- Hypersensitivity to capecitabine, 5FU, tegafur or one of its excipients
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
France13 sites
Centre Paul Papin
Angers, 49033
Centre Hospitalier
Armentières, 59280
Centre Hospitalier de Béthune
Beuvry, 62660
Centre Hospitalier de CHOLET
Cholet, 49300
Centre Leonard de Vinci
Dechy, 59187
Polyclinique du Bois
Lille, 59000
Centre Oscar Lambret
Lille, 59020
Hopital Saint Vincent de Paul
Lille, 59020
Centre Hospitalier Regional
Lille, 59035
Centre Hospitalier
Roubaix, 59100
Centre Joliot-Curie
Saint Martin Les Boulogne, 62280
Centre Hospitalier
Valenciennes, 59300
Clinique des Dentellieres
Valenciennes, 59300
About this study
Official title: Open Comparative Study With a Cross-over According to Patients'Preference Receiving Xeloda or UFT With Folinic Acid in Advanced or Metastatic Colo-rectal Cancer
The scope of the trial is to determine the preference of patients, after randomization and cross-over, for one of the two treatments.
Another objective of the trial is to assess and compare the safety of each treatment.
Read the detailed description
Further study details as provided by Centre Oscar Lambret.
- Conditions
- Colorectal Cancer
- Being tested
- XELODA, TEGAFUR URACIL - FOLINIC ACID
- Keywords
- colo-rectal cancer, advanced, metastatic, locally advanced or metastatic colo-rectal cancer
- Medical subject headings
- Colorectal Neoplasms, Colonic Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XELODADrug
XELODA, 2500 mg/m²/bid, with approximatively an interval of 12 hours, 30 minutes after breakfast and dinner - during 14 days.
Cycle treatment duration : 21 days
TEGAFUR URACIL - FOLINIC ACIDDrug
Tegafur 300 mg/m2/tid with folinic acid 75 mg/tid during 28 days.
Duration of treatment cycle : 35 days.
| Study group | Role | What they receive |
|---|---|---|
| XELODA | Other | Not described Receives: Drug: XELODA |
| UFT | Other | Not described Receives: Drug: TEGAFUR URACIL - FOLINIC ACID |
What is being measured
The primary outcome is the main question the study is designed to answer.
patients preference after randomization and cross-over
Measured: after 2 cycles of treatment
Secondary outcomes (1)
safety of each treatment
Measured: at day 56 (after two cycles of treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2009 (estimated)
- Study start14 Nov 2005
- Primary completionJun 2010
- Study completionSep 2011
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
- Crossover
- Masking
- None (open label)
- Enrolment
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Oscar Lambret
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- ADENIS Antoine, MD,PhD, Principal investigator, Centre Oscar Lambret
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00905047
- Sponsor's protocol ID
- COLOCROSS-0501
- Other IDs
- 2005-002443-11, 2005
- Acronym
- COLOCROSS
- Status last verified
- Sep 2026
- First submitted
- 18 May 2009
- Last updated
- 17 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open Comparative Study With a Cross-over According to Patients'Preference Receiving Xeloda or UFT With Folinic Acid in Advanced or Metastatic Colo-rectal Cancer
- ClinicalTrials.gov ID
- NCT00905047
- Acronym / sponsor ID
- COLOCROSS / COLOCROSS-0501
- Conditions
- Colorectal Cancer
- Keywords
- colo-rectal cancer, advanced, metastatic, locally advanced or metastatic colo-rectal cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 89 participants (actual)
- Lead sponsor
- Centre Oscar LambretUniversity, hospital or other
- Study start
- 14 Nov 2005 (actual)
- Primary completion
- Jun 2010 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 20 May 2009 (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 scope of the trial is to determine the preference of patients, after randomization and cross-over, for one of the two treatments.
Another objective of the trial is to assess and compare the safety of each treatment.
Detailed description
Further study details as provided by Centre Oscar Lambret.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| XELODA | Other | Drug: XELODA |
| UFT | Other | Drug: TEGAFUR URACIL - FOLINIC ACID |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Locally advanced or metastatic colo-rectal cancer
- Age > or = 18 years old
- PS-WHO < or = 2
- Polynuclear neutrophil leukocytes > or = 1500/mm3, platelets > or = 100000/mm3
- Total bilirubin < or = 3 ULN, ASAT-ALAT < or = 2.5 ULN
Key exclusion criteria (7 listed)
- Concomitant radiotherapy
- Contraindication to fluoropyrimidines
- Treatment with sorivudine and its chemical analogs such as brivudine
- Severe hepatic insufficiency
- Severe renal 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 |
|---|---|---|
| XELODAXELODA, 2500 mg/m²/bid, with approximatively an interval of 12 hours, 30 minutes after breakfast and dinner - during 14 days. Cycle treatment duration : 21 days | Drug | XELODA |
| TEGAFUR URACIL - FOLINIC ACIDTegafur 300 mg/m2/tid with folinic acid 75 mg/tid during 28 days. Duration of treatment cycle : 35 days. | Drug | UFT |
Primary outcome
patients preference after randomization and cross-over
Time frame: after 2 cycles of treatment
1 secondary outcome
safety of each treatment
Time frame: at day 56 (after two cycles of treatment)
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 17 Sep 2026.
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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.
ADENIS Antoine, MD,PhD principal investigator
Centre Oscar Lambret
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing XELODA and TEGAFUR URACIL - FOLINIC ACID in people with Colorectal Cancer, run by Centre Oscar Lambret at 13 sites 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 7 inclusion and 7 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 17 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites 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?
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?
patients preference after randomization and cross-over (time frame: after 2 cycles of treatment). 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 17 Sep 2026.