Colorectal CancerPhase 2NCT00209703
Feasibility Study of mFOLFOX6 in Patients With Advanced Colorectal Cancer
A Phase 2 study testing Oxaliplatin, l-Leucovorin and 5-Fluorouracil in people with Colorectal Cancer, run by Hokkaido Gastrointestinal Cancer Study Group at 1 site in Japan.
Trial summary
We performed a feasibility study of mFOLFOX6 in advanced colorectal cancer in Japan and to estimate the safety and efficacy of this regimen. Read more about this study
- Who is it for?
- Ages 15 to 75 years
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Oxaliplatin, l-Leucovorin and 5-Fluorouracil
- How many people
- 30 participants
- Where
- 1 siteJapan
- Study dates
- Jan 2005to Jun 2007
- 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 15 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Histological diagnosis of colorectral adenocarcinoma.
- Measurable or assessable lesions.
- Age: 15 ~ 75 years.
- Performance Status (ECOG): 0 ~ 2.
- Prior chemotherapy within 2 regimens.
- Adequate function of major organs (bone marrow, heart, lungs, liver etc.). WBC 3,500/mm3. Hb 10.0 g/dl. Platelet count 100,000/mm3. GOT and GPT 2.5times the upper limit of normal (excluding liver metastasis). T-Bil 3.0mg/dl. Creatinine within the upper limit of normal. Normal ECG (not considering clinically unimportant arrhythmias and ischemic changes).
- Predicted survival for >8 weeks. (11) Able to give written informed consent.
Who cannot join
- Severe pleural effusion or ascites.
- Metastasis to the central nervous system (CNS).
- Active gastrointestinal bleeding.
- Active infection.
- Uncontrolled ischemic heart disease.
- Serious complications (such as intestinal paralysis, intestinal obstruction, interstitial pneumonia or pulmonary fibrosis, uncontrolled diabetes mellitus, heart failure, renal failure, or hepatic failure).
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- Active multiple cancer.
- Severe mental disorder.
- Pregnancy, possible pregnancy, or breast-feeding.
- Patients with neuropathy ≥ grade 2
- Judged to be ineligible for this protocol by the attending physician.
Trial locations and contacts
1 site in 1 country.
Japan1 site
Hokkaido University Hospital (Hokkaido University Graduate School of Medicine)
Sapporo, Hokkaido, 060-8638
About this study
Official title: Feasibility Study of mFOLFOX6 (Oxaliplatin Combined With l-Leucovorin (l-LV) and 5-Fluorouracil) in Patients With Advanced Colorectal Cancer
We performed a feasibility study of mFOLFOX6 in advanced colorectal cancer in Japan and to estimate the safety and efficacy of this regimen.
Read the detailed description
A multicenter Open-label, single-arm feasibility study is conducted on patients with histological stage IV colorectal cancer given oxaliplatin, leucovorin plus fluorouracil. The usefulness of this regimens as therapy for colorectal cancer was evaluated by the disease-free survival rate (DFR), overall survival rate (OS), incidence and severity of adverse event.
- Conditions
- Colorectal Cancer
- Being tested
- Oxaliplatin, l-Leucovorin, 5-Fluorouracil
- 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
l-LeucovorinDrug
5-FluorouracilDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and severity of adverse event
Secondary outcomes (1)
Determine the clinical response rate, disease-free survival(DFS), overall survival(OS)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2005 (estimated)
- Study startJan 2005
- Study completionJun 2007
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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants
Sponsor and investigators
- Lead sponsor
- Hokkaido Gastrointestinal Cancer Study Group
- Sponsor type
- University, hospital or other
- Investigators
- Masahiro Asaka, MD, PhD, Study chair, Hokkaido Gastrointestinal Cancer Study Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00209703
- Sponsor's protocol ID
- HGCSG0501
- Status last verified
- Apr 2006
- First submitted
- 13 Sep 2005
- Last updated
- 21 Apr 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Study of mFOLFOX6 (Oxaliplatin Combined With l-Leucovorin (l-LV) and 5-Fluorouracil) in Patients With Advanced Colorectal Cancer
- ClinicalTrials.gov ID
- NCT00209703
- Acronym / sponsor ID
- HGCSG0501
- Conditions
- Colorectal Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 30 participants
- Lead sponsor
- Hokkaido Gastrointestinal Cancer Study GroupUniversity, hospital or other
- Study start
- Jan 2005
- Study completion
- Jun 2007
- First posted
- 21 Sep 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.
We performed a feasibility study of mFOLFOX6 in advanced colorectal cancer in Japan and to estimate the safety and efficacy of this regimen.
Detailed description
A multicenter Open-label, single-arm feasibility study is conducted on patients with histological stage IV colorectal cancer given oxaliplatin, leucovorin plus fluorouracil. The usefulness of this regimens as therapy for colorectal cancer was evaluated by the disease-free survival rate (DFR), overall survival rate (OS), incidence and severity of adverse event.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 15 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Histological diagnosis of colorectral adenocarcinoma.
- Measurable or assessable lesions.
- Age: 15 ~ 75 years.
- Performance Status (ECOG): 0 ~ 2.
- Prior chemotherapy within 2 regimens.
Key exclusion criteria (11 listed)
- Severe pleural effusion or ascites.
- Metastasis to the central nervous system (CNS).
- Active gastrointestinal bleeding.
- Active infection.
- Uncontrolled ischemic heart disease.
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 | – |
| l-Leucovorin | Drug | – |
| 5-Fluorouracil | Drug | – |
Primary outcome
Incidence and severity of adverse event
1 secondary outcome
Determine the clinical response rate, disease-free survival(DFS), overall survival(OS)
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2006.
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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.
Masahiro Asaka, 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 2 study testing Oxaliplatin, l-Leucovorin and 5-Fluorouracil in people with 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 7 inclusion and 11 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: stopped early, as of the sponsor's last update on 21 Apr 2006. 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 was stopped early. 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?
Incidence and severity of adverse event. 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 21 Apr 2006.