Colonic NeoplasmsPhase 4NCT00263055
MASCOT : Multicenter Asia Study in Adjuvant Treatment of Colon Cancer With OxaliplaTin/5FU-LV
A Phase 4 study testing oxaliplatin in people with Colonic Neoplasms, run by Sanofi at 5 sites in 5 countries.
Trial summary
Safety \& tolerability of FOLFOX4 regimen in the adjuvant treatment of colon cancer in Asian patients Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Colonic Neoplasms
- What is being tested?
- oxaliplatin
- How many people
- Not given
- Where
- 5 sitesin 5 countries
- Study dates
- Aug 2004to Jun 2005
- Phase
- Phase 4
- 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
- Histologically proven stage Dukes " B2 " (stage II: T3-T4 N0 M0) and " C " (stage III: any T N1-2 M0) colon carcinoma. The inferior pole of the tumor must be above the peritoneal reflection (> 15 cm from the anal margin).
- Patients must have undergone complete resection of the primary tumor without gross or microscopic evidence of residual disease
- Patients must be entered in the study in order to start treatment within 7 weeks after surgery
- Age 18-75 years old
- Performance Status ≤ 2 (Karnofsky > or = 60%)
- No previous chemotherapy, immunotherapy or radiotherapy
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- No biological major abnormalities :Absolute neutrophil count > 1.5 x 10^9/l,Platelets ≥ 100 x 10^9/l,Serum creatinine ≤ 1.25 times the upper limit of normal, total bilirubin, ASAT / ALAT < 2 times the upper limit of the normal range,carcinoembryonic antigen < 10 ng/ml.
- Documentation of a negative pregnancy test must be available for premenopausal women with intact reproductive organs
- Men and women who are fertile must use a medically acceptable contraceptive throughout the treatment period and for 3 months following cessation of treatment with oxaliplatin. Subjects must be made aware, before entering this trial of the risk of becoming pregnant or in fathering children
- Signed informed consent obtained prior to study entry
Who cannot join
- Pregnant or lactating women
- Women of child bearing potential not using a contraceptive method
- Previous cancer of the colon or rectum
- Previous malignancies other than adequately treated in situ carcinoma of the uterine cervix or basal or squamous cell carcinoma of the skin, unless there has been a disease-free interval of at least 10 years
- Participation in another clinical trial with any investigational drug within 30 days prior to randomization
- Peripheral neuropathy (NCI CTC [National Cancer Institute Common Toxicity Criteria] > or = Grade I)
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- Uncontrolled congestive heart failure or angina pectoris, or hypertension or arrhythmia
- History of significant neurologic or psychiatric disorders
- Active infection
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Trial locations and contacts
5 sites in 5 countries.
5 sites in 5 countries
About this study
Official title: Multicenter Asia Study in Adjuvant Treatment of Colon Cancer With OxaliplaTin/5FU-LV
Safety \& tolerability of FOLFOX4 regimen in the adjuvant treatment of colon cancer in Asian patients
- Conditions
- Colonic Neoplasms
- Being tested
- oxaliplatin
- Medical subject headings
- Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oxaliplatinDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of dose-limiting toxicity
Measured: from the inform consent signed up to the end of the study
Secondary outcomes (10)
Occurrence of one or more adverse event in a patient
Measured: From the Informed Consent Form (ICF) signature to the end of the study
Overall distribution of intensity of adverse events
Measured: from the inform consnet signed up to the end of the study
Occurrence of particular adverse events and their intensities
Measured: from the inform consent signed up to the end of the study
Percent of patients completing study treatment
Measured: from the inform consent signed up to the end of the study
Percent of patients with grade 1, 2 and 3 neuropathy
Measured: at 28 days, 6 months and 12 months after last chemotherapy administration.
Percent of intended dose delivered for 5-FU/LV and Oxaliplatin
Measured: from the informed consent signed up to the end of the study
Delays in scheduled dosing
Measured: During the study conduct
Dose intensity, as expressed as the amount of 5-FU/LV and Oxaliplatin administered divided by the duration of treatment
Measured: during the study conduct
•Survival Analysis •Laboratory assay and vital signs ECOG and KPS
Measured: during the study conduct
Long term toxicity
Measured: during the study conduct
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2005 (estimated)
- Study startAug 2004
- Primary completionJun 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colonic NeoplasmsStudies of the same condition, open and under way.
- More trials run by SanofiThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Claude Valterio, MD, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00263055
- Sponsor's protocol ID
- R_9262
- Status last verified
- Sep 2009
- First submitted
- 6 Dec 2005
- Last updated
- 15 Sep 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Asia Study in Adjuvant Treatment of Colon Cancer With OxaliplaTin/5FU-LV
- ClinicalTrials.gov ID
- NCT00263055
- Acronym / sponsor ID
- R_9262
- Conditions
- Colonic Neoplasms
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Aug 2004
- Primary completion
- Jun 2005 (actual)
- First posted
- 7 Dec 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.
Safety \& tolerability of FOLFOX4 regimen in the adjuvant treatment of colon cancer in Asian patients
Study design
- Primary purpose
- Treatment
- Allocation
- Non-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 (10 listed)
- Histologically proven stage Dukes " B2 " (stage II: T3-T4 N0 M0) and " C " (stage III: any T N1-2 M0) colon carcinoma. The inferior pole of the tumor must be above the peritoneal reflection (> 15 cm from the anal margin).
- Patients must have undergone complete resection of the primary tumor without gross or microscopic evidence of residual disease
- Patients must be entered in the study in order to start treatment within 7 weeks after surgery
- Age 18-75 years old
- Performance Status ≤ 2 (Karnofsky > or = 60%)
Key exclusion criteria (10 listed)
- Pregnant or lactating women
- Women of child bearing potential not using a contraceptive method
- Previous cancer of the colon or rectum
- Previous malignancies other than adequately treated in situ carcinoma of the uterine cervix or basal or squamous cell carcinoma of the skin, unless there has been a disease-free interval of at least 10 years
- Participation in another clinical trial with any investigational drug within 30 days prior to randomization
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 |
|---|---|---|
| oxaliplatin | Drug | – |
Primary outcome
Occurrence of dose-limiting toxicity
Time frame: from the inform consent signed up to the end of the study
10 secondary outcomes
Occurrence of one or more adverse event in a patient
Time frame: From the Informed Consent Form (ICF) signature to the end of the study
Overall distribution of intensity of adverse events
Time frame: from the inform consnet signed up to the end of the study
Occurrence of particular adverse events and their intensities
Time frame: from the inform consent signed up to the end of the study
Percent of patients completing study treatment
Time frame: from the inform consent signed up to the end of the study
Percent of patients with grade 1, 2 and 3 neuropathy
Time frame: at 28 days, 6 months and 12 months after last chemotherapy administration.
Percent of intended dose delivered for 5-FU/LV and Oxaliplatin
Time frame: from the informed consent signed up to the end of the study
Delays in scheduled dosing
Time frame: During the study conduct
Dose intensity, as expressed as the amount of 5-FU/LV and Oxaliplatin administered divided by the duration of treatment
Time frame: during the study conduct
•Survival Analysis •Laboratory assay and vital signs ECOG and KPS
Time frame: during the study conduct
Long term toxicity
Time frame: during the study conduct
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 15 Sep 2009.
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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.
Claude Valterio, MD study director
Sanofi
5 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing oxaliplatin in people with Colonic Neoplasms, run by Sanofi at 5 sites in 5 countries.
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 10 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: finished, as of the sponsor's last update on 15 Sep 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in China, Hong Kong, South Korea, Taiwan, Thailand. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Occurrence of dose-limiting toxicity (time frame: from the inform consent signed up to the end of the study). 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 15 Sep 2009.