Metastatic Colorectal CancerPhase 3NCT00316745
IRIS Followed by mFOLFOX6 or the Reverse Sequence in Advanced Colorectal Cancer
A Phase 3 study testing Campto, Topotesin, TS-1 and L-Plat in people with Metastatic Colorectal Cancer, run by Hokkaido Gastrointestinal Cancer Study Group at 1 site in Japan.
Trial summary
This randomized phase III study compares safety and efficacy of two sequence arms in advanced colorectal cancer: irinotecan and S-1 (IRIS) followed by oxaliplatin containing regimen (arm A), or l-leucovorin (l-LV), 5-FU and oxaliplatin (mFOLFOX6) followed by irinotecan containing regimen (arm B). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Metastatic Colorectal Cancer
- What is being tested?
- Campto, Topotesin, TS-1 and L-Plat
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteJapan
- Study dates
- Apr 2006to Mar 2009
- 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
- 1. Histological diagnosis of colorectal cancer. 2） Age: 18 - 75 years. 3） No prior chemotherapy 4） ECOG Performance Status 0 to 2 5) A life expectancy of at least 3 months 6) Adequate function of major organs (bone marrow, heart, lungs, liver etc.). WBC ≧3,500/mm3 and Neutrophil ≧2,000/mm3. Hb ≧10.0 g/dl. Platelet count ≧100,000/mm3. AST and ALT ≦2.5 times the upper limit of normal (excluding liver metastasis). T-Bil ≦1.5 mg/dl. Creatinine ≦1.5 mg/ dl. 7).Patients must have the ability to understand and the willingness to sign a written informed contact document.
Who cannot join
- Patients receiving blood transfusion, blood derivatives or granulocyte-colony stimulating factor within 7days prior to entering the study.
- Patients can not have oral intake
- Patients receiving Flucytosine treatment
- Patients with severe pleural effusion or ascites.
- Patients who have brown brain metastasis
- Patients with diarrhea 4 or more times per day
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- Patients with active gastrointestinal bleeding.
- Patients with intestinal obstruction
- Patients with active infection.
- Patients with serious pulmonary disease (such as interstitial pneumonia, pulmonary fibrosis, pulmonary emphysema)
- Patients with serious complications (such as intestinal paralysis, intestinal obstruction, interstitial pneumonia or pulmonary fibrosis, uncontrolled diabetes mellitus, heart failure, renal failure, or hepatic failure).
- Patients with significant cardiac disease.
- Patients with active multiple cancer.
- Patients with neuropathy ≥ grade 2
- Patients who are pregnant, are of childbearing potential, or breast-feeding.
- Patients with severe mental disorder.
- Patients with a history of serious allergic reaction.
- Judged to be ineligible for this protocol by the investigation.
- -
Trial locations and contacts
1 site in 1 country.
Japan1 site
Hokkaido University Hospital (Hokkaido University Graduate School of Medicine / School of Medicine)
Sapporo, Hokkaido, 060-8638
About this study
Official title: Irinotecan Combined With S-1( IRIS ) Followed by mFOLFOX6 Regimen Versus mFOLFOX6 Followed by IRIS Regimen in Advanced Colorectal Cancer
This randomized phase III study compares safety and efficacy of two sequence arms in advanced colorectal cancer: irinotecan and S-1 (IRIS) followed by oxaliplatin containing regimen (arm A), or l-leucovorin (l-LV), 5-FU and oxaliplatin (mFOLFOX6) followed by irinotecan containing regimen (arm B).
Read the detailed description
A multicenter randomized open-label controlled phase III study is conducted in patients with inoperable advanced or metastatic colorectal cancer who receive no previous chemotherapy. Usefulness of IRIS and mFOLFOX6 regimens as the 1st-line therapy for colorectal cancer is evaluated in PFS, MST, incidence and severity of adverse events
- Conditions
- Metastatic Colorectal Cancer
- Being tested
- Campto, Topotesin, TS-1, L-Plat, Isovorin, 5-FU
- Keywords
- irinotecan, S-1, Oxaliplatin, l-leucovorin, Fluorouracil, Metastatic colorectal cancer, phase III
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Campto, TopotesinDrug
Also called Irinotecan
100 mg/m2, IV (in the vein) on day 1,15 of each cycle.
TS-1Drug
Also called S-1
S-1 Day1~14, everyday P.O.(Day 15~28 rest)
L-PlatDrug
Also called Oxaliplatin
Oxaliplatin (85mg/m2) Day 1, 15
IsovorinDrug
Also called l-leucovorin
l-leucovorin (200mg/m2) Day 1, 15
5-FUDrug
Also called Fluorouracil
400 mg/m2, IV (in the vein) on day 1,15 of each 28 day cycle. 2400 mg/m2, CIV (in the vein) on day 1~3 (48 hours) of each 28 day cycle.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | mFOLFOX6 （ → IRIS ( Irinotecan and S-1) ） Receives: Drug: L-Plat; Drug: Isovorin; Drug: 5-FU |
| 2 | Experimental | IRIS ( Irinotecan and S-1 ) → mFOLFOX6 Receives: Drug: Campto, Topotesin; Drug: TS-1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
PFS of 1st line treatment
Measured: 2-years
Secondary outcomes (4)
OS
Measured: 4-years
objective tumor response
Measured: 1-year
PFS of 2nd line treatment
Measured: 1-year
safety
Measured: 4-years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2006 (estimated)
- Study startApr 2006
- Study completionMar 2009 (estimated)
Why it stopped: Because of approval of Bevacizumab, it was difficult to perform clinical study in 1st line setting.
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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hokkaido Gastrointestinal Cancer Study Group
- Sponsor type
- University, hospital or other
- Collaborators
- Hokkaido University Hospital
- Investigators
- Yoshito Komatsu, MD, PhD, Study chair, Hokkaido Gastrointestinal Cancer Study Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00316745
- Sponsor's protocol ID
- HGCSG0601
- Other IDs
- IFOX study
- Status last verified
- Oct 2007
- First submitted
- 19 Apr 2006
- Last updated
- 1 Nov 2007
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Irinotecan Combined With S-1( IRIS ) Followed by mFOLFOX6 Regimen Versus mFOLFOX6 Followed by IRIS Regimen in Advanced Colorectal Cancer
- ClinicalTrials.gov ID
- NCT00316745
- Acronym / sponsor ID
- HGCSG0601
- Conditions
- Metastatic Colorectal Cancer
- Keywords
- irinotecan, S-1, Oxaliplatin, l-leucovorin, Fluorouracil, Metastatic colorectal cancer, phase III
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Because of approval of Bevacizumab, it was difficult to perform clinical study in 1st line setting.
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Hokkaido Gastrointestinal Cancer Study GroupUniversity, hospital or other
- Collaborators
- Hokkaido University Hospital
- Study start
- Apr 2006
- Study completion
- Mar 2009 (estimated)
- First posted
- 21 Apr 2006 (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.
This randomized phase III study compares safety and efficacy of two sequence arms in advanced colorectal cancer: irinotecan and S-1 (IRIS) followed by oxaliplatin containing regimen (arm A), or l-leucovorin (l-LV), 5-FU and oxaliplatin (mFOLFOX6) followed by irinotecan containing regimen (arm B).
Detailed description
A multicenter randomized open-label controlled phase III study is conducted in patients with inoperable advanced or metastatic colorectal cancer who receive no previous chemotherapy. Usefulness of IRIS and mFOLFOX6 regimens as the 1st-line therapy for colorectal cancer is evaluated in PFS, MST, incidence and severity of adverse events
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: L-Plat, Drug: Isovorin, Drug: 5-FUmFOLFOX6 （ → IRIS ( Irinotecan and S-1) ） |
| 2 | Experimental | Drug: Campto, Topotesin, Drug: TS-1IRIS ( Irinotecan and S-1 ) → mFOLFOX6 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1. Histological diagnosis of colorectal cancer. 2） Age: 18 - 75 years. 3） No prior chemotherapy 4） ECOG Performance Status 0 to 2 5) A life expectancy of at least 3 months 6) Adequate function of major organs (bone marrow, heart, lungs, liver etc.). WBC ≧3,500/mm3 and Neutrophil ≧2,000/mm3. Hb ≧10.0 g/dl. Platelet count ≧100,000/mm3. AST and ALT ≦2.5 times the upper limit of normal (excluding liver metastasis). T-Bil ≦1.5 mg/dl. Creatinine ≦1.5 mg/ dl. 7).Patients must have the ability to understand and the willingness to sign a written informed contact document.
Key exclusion criteria (19 listed)
- Patients receiving blood transfusion, blood derivatives or granulocyte-colony stimulating factor within 7days prior to entering the study.
- Patients can not have oral intake
- Patients receiving Flucytosine treatment
- Patients with severe pleural effusion or ascites.
- Patients who have brown brain metastasis
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 |
|---|---|---|
| Campto, TopotesinAlso: Irinotecan100 mg/m2, IV (in the vein) on day 1,15 of each cycle. | Drug | 2 |
| TS-1Also: S-1S-1 Day1~14, everyday P.O.(Day 15~28 rest) | Drug | 2 |
| L-PlatAlso: OxaliplatinOxaliplatin (85mg/m2) Day 1, 15 | Drug | 1 |
| IsovorinAlso: l-leucovorinl-leucovorin (200mg/m2) Day 1, 15 | Drug | 1 |
| 5-FUAlso: Fluorouracil400 mg/m2, IV (in the vein) on day 1,15 of each 28 day cycle. 2400 mg/m2, CIV (in the vein) on day 1~3 (48 hours) of each 28 day cycle. | Drug | 1 |
Primary outcome
PFS of 1st line treatment
Time frame: 2-years
4 secondary outcomes
OS
Time frame: 4-years
objective tumor response
Time frame: 1-year
PFS of 2nd line treatment
Time frame: 1-year
safety
Time frame: 4-years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2007.
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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.
Yoshito Komatsu, MD, PhD study chair
Hokkaido Gastrointestinal Cancer Study Group
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 Campto, Topotesin, TS-1 and L-Plat in people with Metastatic Colorectal Cancer, run by Hokkaido Gastrointestinal Cancer Study Group 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 1 inclusion and 19 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: paused, as of the sponsor's last update on 1 Nov 2007. 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.
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?
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?
PFS of 1st line treatment (time frame: 2-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 1 Nov 2007.