Metastatic Colorectal CancerNCT01039506
An Observational Study of CPT-11 Based Regimens and UGT1A1 Genotypes in Metastatic Colorectal Cancer (mCRC)
An observational study of Metastatic Colorectal Cancer, run by Daiichi Sankyo Co., Ltd. at 1 site in Japan.
Trial summary
The purpose of this study is to examine the correlation between UGT1A1 genotypes and the efficacy of CPT-11 based regimens (FOLFIRI, CPT-11+S-1, CPT-11) for patients with metastatic colorectal cancer. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Metastatic Colorectal Cancer
- What is being tested?
- CPT-11 based regimens
- How many people
- 1,376 participants
- Where
- 1 siteJapan
- Study dates
- 15 Oct 2009to 1 Jul 2016
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with metastatic colorectal cancer treated with CPT-11 based regimens (FOLFIRI, CPT-11+S-1, CPT-11) in clinical practice in Japan
Who may be able to join
- Metastatic colorectal cancer (adenocarcinoma)
- UGT1A1 genotyped patients
- Patients to receiving FOLFIRI, CPT-11+S-1 and CPT-11 alone therapy (with or without molecular targeted agents)
Who cannot join
- Contraindication of CPT-11
- Eastern Cooperative Oncology Group (ECOG) Performance Score (PS) 3-4
- Patients to receiving CPT-11 as adjuvant chemotherapy
- History of pelvic irradiation
Trial locations and contacts
1 site in 1 country.
Japan1 site
Department of Clinical Oncology, National Defense Medical College Hospital
Tokorozawa-shi, Saitama, 359-8513
About this study
Official title: A Prospective Observational Study of the Efficacy and Safety of CPT-11 Based Regimens for UGT1A1 Genotype Guided Patients With Metastatic Colorectal Cancer
The purpose of this study is to examine the correlation between UGT1A1 genotypes and the efficacy of CPT-11 based regimens (FOLFIRI, CPT-11+S-1, CPT-11) for patients with metastatic colorectal cancer.
- Conditions
- Metastatic Colorectal Cancer
- Being tested
- CPT-11 based regimens
- Keywords
- UGT1A1, irinotecan
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CPT-11 based regimensDrug
Also called FOLFIRI, CPT-11+S-1, CPT-11
| Study group | Role | What they receive |
|---|---|---|
| UGT1A1 genotyped patients | UGT1A1 genotyped patients receive CPT-11 based regimens Receives: Drug: CPT-11 based regimens |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression free survival
Percentage of participants alive without disease progression
Measured: Within 3 years
Secondary outcomes (5)
Overall survival
Percentage of participants alive at end of study
Measured: At 3 years
Time to treatment failure
Duration of time (in months) from treatment to failure
Measured: Within 3 years
Response rate
Percentage of participants with an objective response
Measured: from Day 1 (treatment) through disease progression (within 3 years)
Disease control rate
Percentage of participants with controlled disease
Measured: Within 3 years
Safety events
Adverse events will be collected during treatment
Measured: Within 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Dec 2009 (estimated)
- Study start15 Oct 2009
- Primary completion28 Apr 2016
- Study completion1 Jul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,376 participants (actual)
Sponsor and investigators
- Lead sponsor
- Daiichi Sankyo Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01039506
- Sponsor's protocol ID
- TOP009-061
- Other IDs
- 090945
- Status last verified
- May 2019
- First submitted
- 23 Dec 2009
- Last updated
- 29 May 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Observational Study of the Efficacy and Safety of CPT-11 Based Regimens for UGT1A1 Genotype Guided Patients With Metastatic Colorectal Cancer
- ClinicalTrials.gov ID
- NCT01039506
- Acronym / sponsor ID
- TOP009-061
- Conditions
- Metastatic Colorectal Cancer
- Keywords
- UGT1A1, irinotecan
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,376 participants (actual)
- Lead sponsor
- Daiichi Sankyo Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 15 Oct 2009 (actual)
- Primary completion
- 28 Apr 2016 (actual)
- Study completion
- 1 Jul 2016 (actual)
- First posted
- 25 Dec 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 purpose of this study is to examine the correlation between UGT1A1 genotypes and the efficacy of CPT-11 based regimens (FOLFIRI, CPT-11+S-1, CPT-11) for patients with metastatic colorectal cancer.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| UGT1A1 genotyped patients | – | Drug: CPT-11 based regimensUGT1A1 genotyped patients receive CPT-11 based regimens |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with metastatic colorectal cancer treated with CPT-11 based regimens (FOLFIRI, CPT-11+S-1, CPT-11) in clinical practice in Japan
Key inclusion criteria (3 listed)
- Metastatic colorectal cancer (adenocarcinoma)
- UGT1A1 genotyped patients
- Patients to receiving FOLFIRI, CPT-11+S-1 and CPT-11 alone therapy (with or without molecular targeted agents)
Key exclusion criteria (4 listed)
- Contraindication of CPT-11
- Eastern Cooperative Oncology Group (ECOG) Performance Score (PS) 3-4
- Patients to receiving CPT-11 as adjuvant chemotherapy
- History of pelvic irradiation
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 |
|---|---|---|
| CPT-11 based regimensAlso: FOLFIRI, CPT-11+S-1, CPT-11 | Drug | UGT1A1 genotyped patients |
Primary outcome
Progression free survival
Time frame: Within 3 years
Percentage of participants alive without disease progression
5 secondary outcomes
Overall survival
Time frame: At 3 years
Time to treatment failure
Time frame: Within 3 years
Response rate
Time frame: from Day 1 (treatment) through disease progression (within 3 years)
Disease control rate
Time frame: Within 3 years
Safety events
Time frame: Within 3 years
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 29 May 2019.
- Individual participant dataSharing planned: No
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CRC
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Metastatic Colorectal Cancer, run by Daiichi Sankyo Co., Ltd. at 1 site in Japan.
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 4 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 29 May 2019. 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 Japan. 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.
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?
Progression free survival (time frame: Within 3 years). 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 29 May 2019.