Colorectal CancerPhase 2NCT00721916
Randomized Phase II Study of SOL for Untreated Metastatic Colorectal Cancer
A Phase 2 study testing SOL(The combination therapy of S-1, Leucovorin, and Oxaliplatin) and mFOLFOX6(The combination therapy of 5-FU, l-LV and Oxaliplatin) in people with Colorectal Cancer, run by Taiho Pharmaceutical Co., Ltd. at 1 site in Japan.
Trial summary
This is a randomized, multicenter study designed to evaluate the progression free survival of the SOL group (S-1, Leucovorin, and Oxaliplatin) compared with the mFOLFOX6 group (5-FU, l-LV and Oxaliplatin) as first-line treatment of patients with metastatic colorectal cancer. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- SOL(The combination therapy of S-1, Leucovorin, and Oxaliplatin) and mFOLFOX6(The combination therapy of 5-FU, l-LV and Oxaliplatin)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 107 participants
- Where
- 1 siteJapan
- Study dates
- Jul 2008to May 2012
- Phase
- Phase 2
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically proved adenocarcinoma (colorectal cancer).
- Age: 20 ≤ at enrollment.
- No prior treatment (ex. radiation therapy, chemotherapy, hormonal therapy) to advanced disease. Patients who received adjuvant chemotherapy more than 180 days before enrollment can be allowed but those who received S-1 or Oxaliplatin containing treatment shall be excluded.
- At least one measurable lesion by RECIST criteria
Who cannot join
- Serious drug hypersensitivity.
- Prior history of peripheral neuropathy.
- Diarrhea .
- Simultaneously active double cancer.
Trial locations and contacts
1 site in 1 country.
Japan1 site
Shizuoka Cancer Center
Shimonagakubo Nagaizumi-cho Sunto-gun, Shizuoka, 411-8777
About this study
Official title: Randomized Phase II Study of S-1, Oral Leucovorin, and Oxaliplatin Combination Therapy (SOL) Versus 5-FU, l-LV and Oxaliplatin Combination Therapy (mFOLFOX6) in Patients With Untreated Metastatic Colorectal Cancer
This is a randomized, multicenter study designed to evaluate the progression free survival of the SOL group (S-1, Leucovorin, and Oxaliplatin) compared with the mFOLFOX6 group (5-FU, l-LV and Oxaliplatin) as first-line treatment of patients with metastatic colorectal cancer.
- Conditions
- Colorectal Cancer
- Being tested
- SOL(The combination therapy of S-1, Leucovorin, and Oxaliplatin), mFOLFOX6(The combination therapy of 5-FU, l-LV and Oxaliplatin)
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SOL(The combination therapy of S-1, Leucovorin, and Oxaliplatin)Drug
L-OHP 85 mg/m2 iv. for 2 hr on day 1 of each 2 weeks cycle S-1 40-60 mg bid day 1～day 7 LV 25 mg bid day 1～day 7
mFOLFOX6(The combination therapy of 5-FU, l-LV and Oxaliplatin)Drug
L-OHP 85 mg/m2 iv. for 2 hr on day 1 of each 2 weeks cycle l-LV 200 mg/m2 iv. for 2 hr on day 1 5-FU 400 mg/m2 bolus on day 1 5-FU 2400 mg/m2 ci for 46 hr (day 1, 2hr～48hr)
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | SOL(The combination therapy of S-1, Leucovorin, and Oxaliplatin) Receives: Drug: SOL(The combination therapy of S-1, Leucovorin, and Oxaliplatin) |
| 2 | Active comparator | mFOLFOX6(The combination therapy of 5-FU, l-LV and Oxaliplatin) Receives: Drug: mFOLFOX6(The combination therapy of 5-FU, l-LV and Oxaliplatin) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression free survival (PFS)
Measured: Until progression
Secondary outcomes (1)
Safety
Measured: During chemotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2008 (estimated)
- Study startJul 2008
- Primary completionMar 2012
- Study completionMay 2012
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 107 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taiho Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Yakult Honsha Co., LTD
- Responsible party
- Sponsor
- Investigators
- Narikazu Boku, MD, Study chair, St. Marianna University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00721916
- Sponsor's protocol ID
- Taiho10020390
- Status last verified
- Oct 2012
- First submitted
- 23 Jul 2008
- Last updated
- 1 Nov 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Phase II Study of S-1, Oral Leucovorin, and Oxaliplatin Combination Therapy (SOL) Versus 5-FU, l-LV and Oxaliplatin Combination Therapy (mFOLFOX6) in Patients With Untreated Metastatic Colorectal Cancer
- ClinicalTrials.gov ID
- NCT00721916
- Acronym / sponsor ID
- Taiho10020390
- Conditions
- Colorectal Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 107 participants (actual)
- Lead sponsor
- Taiho Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Yakult Honsha Co., LTD
- Study start
- Jul 2008
- Primary completion
- Mar 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 25 Jul 2008 (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 is a randomized, multicenter study designed to evaluate the progression free survival of the SOL group (S-1, Leucovorin, and Oxaliplatin) compared with the mFOLFOX6 group (5-FU, l-LV and Oxaliplatin) as first-line treatment of patients with metastatic colorectal cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: SOL(The combination therapy of S-1, Leucovorin, and Oxaliplatin)SOL(The combination therapy of S-1, Leucovorin, and Oxaliplatin) |
| 2 | Active comparator | Drug: mFOLFOX6(The combination therapy of 5-FU, l-LV and Oxaliplatin)mFOLFOX6(The combination therapy of 5-FU, l-LV and Oxaliplatin) |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Histologically proved adenocarcinoma (colorectal cancer).
- Age: 20 ≤ at enrollment.
- No prior treatment (ex. radiation therapy, chemotherapy, hormonal therapy) to advanced disease. Patients who received adjuvant chemotherapy more than 180 days before enrollment can be allowed but those who received S-1 or Oxaliplatin containing treatment shall be excluded.
- At least one measurable lesion by RECIST criteria
Key exclusion criteria (4 listed)
- Serious drug hypersensitivity.
- Prior history of peripheral neuropathy.
- Diarrhea .
- Simultaneously active double cancer.
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 |
|---|---|---|
| SOL(The combination therapy of S-1, Leucovorin, and Oxaliplatin)L-OHP 85 mg/m2 iv. for 2 hr on day 1 of each 2 weeks cycle S-1 40-60 mg bid day 1～day 7 LV 25 mg bid day 1～day 7 | Drug | 1 |
| mFOLFOX6(The combination therapy of 5-FU, l-LV and Oxaliplatin)L-OHP 85 mg/m2 iv. for 2 hr on day 1 of each 2 weeks cycle l-LV 200 mg/m2 iv. for 2 hr on day 1 5-FU 400 mg/m2 bolus on day 1 5-FU 2400 mg/m2 ci for 46 hr (day 1, 2hr～48hr) | Drug | 2 |
Primary outcome
Progression free survival (PFS)
Time frame: Until progression
1 secondary outcome
Safety
Time frame: During chemotherapy
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 1 Nov 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.
Narikazu Boku, MD study chair
St. Marianna University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SOL(The combination therapy of S-1, Leucovorin, and Oxaliplatin) and mFOLFOX6(The combination therapy of 5-FU, l-LV and Oxaliplatin) in people with Colorectal Cancer, run by Taiho Pharmaceutical 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 4 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 1 Nov 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 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Progression free survival (PFS) (time frame: Until progression). 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 2012.