Colorectal CancerPhase 3NCT01566942
FOLFIRI or mFOLFOX6 in Adjuvant Chemotherapy in Advanced Colorectal Cancer
A Phase 3 study testing Oxaliplatin and Irinotecan in people with Colorectal Cancer, run by Sun Yat-sen University at 1 site in China.
Trial summary
the aim of this study is to observe the effect of irinotecan-based regimen in patients with advanced colorectal cancer. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Oxaliplatin and Irinotecan
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- Jun 2012to Jun 2017
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- histologically confirmed adenocarcinoma in colorectal cancer
- clinical stage Ⅲ or Ⅳa(with potential radical resective metastatic lesions),≥ 12 lymph nodes examined
- no cancer cells were found in ascites
- Eastern Cooperative Oncology Group(ECOG) performance status of 0-2
- male or female, between 18 and 75 years old
- adequate hematologic, hepatic and renal functions
Show all 9Show fewer
- without severe heart disease in the last 6 months before enrolled. If with hypertension or coronary artery disease, it can be controlled
- not enrolled into others clinical trial during this study
- all patients should sign the informed consent
Who cannot join
- can not be tolerated operation
- receiving others therapy(including Traditional Chinese herbs)for this disease, can not obey the investigator during the study
- can not be tolerated the adverse effect of drugs in these regimens
- major surgery within 4 weeks prior to study treatment start, or lack of complete recovery from major surgery
- metastatic disease more than one organ
- pregnant or lactating women
Trial locations and contacts
1 site in 1 country.
China1 site
the first affiliated hospital of Sun Yat-sen University
Guangzhou, Guangdong, 510080
JIANJUN PENG, PhD, 86-20-87332200 ext. 8211, aidigua@hotmail.com
About this study
Official title: FOLFIRI or mFOLFOX6 as Adjuvant Chemotherapy Regiment After Neo-adjuvant Chemotherapy With FOLFIRI in Patients With Advanced Colorectal Cancer: a Randomized, Multicenter Clinical Trial
the aim of this study is to observe the effect of irinotecan-based regimen in patients with advanced colorectal cancer.
- Conditions
- Colorectal Cancer
- Being tested
- Oxaliplatin, Irinotecan
- Keywords
- FOLFIRI, FOLFOX, adjuvant chemotherapy, advanced colorectal cancer
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OxaliplatinDrug
In this arm, patients will receive the adjuvant chemotherapy with mFOLFOX6 regimen for 8 cycles. Oxaliplatin 85mg/m2, day1, every 2 weeks; Leucovorin 200mg/m2,day1,every 2 weeks;5-FU 400mg/m2,iv, day1, 5-FU 3.0g/m2, bolus for 46h,every 2 weeks
IrinotecanDrug
In this arm, patients will receive the adjuvant chemotherapy with FOLFIRI regimen for 8 cycles. Irinotecan 180mg/m2, day1, every 2 weeks; Leucovorin 200mg/m2,day1,every 2 weeks;5-FU 400mg/m2,iv, day1, 5-FU 3.0g/m2, bolus for 46h,every 2 weeks
| Study group | Role | What they receive |
|---|---|---|
| FOLFOX | Active comparator | In this group, the patients will receive the adjuvant chemotherapy with mFOLFOX6. Receives: Drug: Oxaliplatin |
| FOLFIRI | Experimental | in this arm, patients will receive adjuvant chemotherapy with FOLFIRI regimen for about 8 cycles Receives: Drug: Irinotecan |
What is being measured
The primary outcome is the main question the study is designed to answer.
disease-free survival（DFS）
The investigator will follow up all the enrolled patients. The difference of 3-year-DFS between two groups will be compared.
Measured: 3-year disease-free survival rate
Secondary outcomes (1)
overall survival(OS)
The 5-year survival rate will be the secondary end point. The investigator will follow up the patients and campare the difference of 5-year-OS between the two groups.
Measured: 5-year survival
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2012 (estimated)
- Study startJun 2012
- Primary completionMay 2014 (estimated)
- Study completionJun 2017 (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.
- More trials run by Sun Yat-sen UniversityThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Collaborators
- First Affiliated Hospital, Sun Yat-Sen University
- Responsible party
- Principal investigator, Yulong He, Sun Yat-sen University
- Investigators
- YULONG HE, PhD, Study chair, First Affiliated Hospital, Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01566942
- Sponsor's protocol ID
- 2011-170
- Status last verified
- Mar 2012
- First submitted
- 26 Mar 2012
- Last updated
- 30 Mar 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- FOLFIRI or mFOLFOX6 as Adjuvant Chemotherapy Regiment After Neo-adjuvant Chemotherapy With FOLFIRI in Patients With Advanced Colorectal Cancer: a Randomized, Multicenter Clinical Trial
- ClinicalTrials.gov ID
- NCT01566942
- Acronym / sponsor ID
- 2011-170
- Conditions
- Colorectal Cancer
- Keywords
- FOLFIRI, FOLFOX, adjuvant chemotherapy, advanced colorectal cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Collaborators
- First Affiliated Hospital, Sun Yat-Sen University
- Study start
- Jun 2012
- Primary completion
- May 2014 (estimated)
- Study completion
- Jun 2017 (estimated)
- First posted
- 30 Mar 2012 (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 aim of this study is to observe the effect of irinotecan-based regimen in patients with advanced colorectal cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FOLFOX | Active comparator | Drug: OxaliplatinIn this group, the patients will receive the adjuvant chemotherapy with mFOLFOX6. |
| FOLFIRI | Experimental | Drug: Irinotecanin this arm, patients will receive adjuvant chemotherapy with FOLFIRI regimen for about 8 cycles |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- histologically confirmed adenocarcinoma in colorectal cancer
- clinical stage Ⅲ or Ⅳa(with potential radical resective metastatic lesions),≥ 12 lymph nodes examined
- no cancer cells were found in ascites
- Eastern Cooperative Oncology Group(ECOG) performance status of 0-2
- male or female, between 18 and 75 years old
Key exclusion criteria (6 listed)
- can not be tolerated operation
- receiving others therapy(including Traditional Chinese herbs)for this disease, can not obey the investigator during the study
- can not be tolerated the adverse effect of drugs in these regimens
- major surgery within 4 weeks prior to study treatment start, or lack of complete recovery from major surgery
- metastatic disease more than one organ
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 |
|---|---|---|
| OxaliplatinIn this arm, patients will receive the adjuvant chemotherapy with mFOLFOX6 regimen for 8 cycles. Oxaliplatin 85mg/m2, day1, every 2 weeks; Leucovorin 200mg/m2,day1,every 2 weeks;5-FU 400mg/m2,iv, day1, 5-FU 3.0g/m2, bolus for 46h,every 2 weeks | Drug | FOLFOX |
| IrinotecanIn this arm, patients will receive the adjuvant chemotherapy with FOLFIRI regimen for 8 cycles. Irinotecan 180mg/m2, day1, every 2 weeks; Leucovorin 200mg/m2,day1,every 2 weeks;5-FU 400mg/m2,iv, day1, 5-FU 3.0g/m2, bolus for 46h,every 2 weeks | Drug | FOLFIRI |
Primary outcome
disease-free survival（DFS）
Time frame: 3-year disease-free survival rate
The investigator will follow up all the enrolled patients. The difference of 3-year-DFS between two groups will be compared.
1 secondary outcome
overall survival(OS)
Time frame: 5-year survival
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2012.
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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.
the first affiliated hospital of Sun Yat-sen University
Guangzhou, China
YULONG HE, PhD study chair
First Affiliated Hospital, Sun Yat-Sen University
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 Oxaliplatin and Irinotecan in people with Colorectal Cancer, run by Sun Yat-sen University at 1 site in China.
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 9 inclusion and 6 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 30 Mar 2012. 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 China. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
disease-free survival（DFS） (time frame: 3-year disease-free survival 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 30 Mar 2012.