Colorectal CancerPhase 3NCT01035385
Compare FOFLOX4 in Preoperative and Postoperative and Postoperative in Resectable Liver Metastasis Colorectal Cancer (MCC)
A Phase 3 study testing FOFLOX4 in people with Colorectal Cancer and Liver Metastasis, run by Guangdong Provincial People's Hospital at 1 site in China.
Trial summary
This study is a multicenter, open-label, randomized ,controlled phase III study to compare preoperative and postoperative with FOFLOX4 chemotherapy and postoperative with FOFLOX4 chemotherapy in patients with resectable liver metastasis from colorectal cancer. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Colorectal Cancer, Liver Metastasis
- What is being tested?
- FOFLOX4
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 340 participants
- Where
- 1 siteChina
- Study dates
- Sep 2009to Dec 2015
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Resectable liver metastasis from colorectal cancer(the distance from the tumor lower edge to anal more than 12cm),no visible extrahepatic metastatic tumors. Curable by resection, as determined by a surgeon and imaging physicians. The minimum of the liver metastases needs ≥2cm. Patients can be recruited if meet the conditions about:
- Primary tumor had been removed of the metachronous liver metastasis patients and no residue from the eyes or microscope.
- Primary tumor has been removed more than 1 month of the simultaneous liver metastasis patients.
- Age of≥18 and ≤80
- ECOG≤2
- Signed written informed consent
Who cannot join
- Peripheral neuropathy(CTC>1)
- Had a neurological or mental disorders
- Active infection
- Allergy to Platinum-based and other drugs
- Other acute diseases including infection, heart-disease(CHF, stable or unstable angina)
- Pregnant or nursing patients
Trial locations and contacts
1 site in 1 country.
Feng Lin, Dr contact
China1 site, 1 recruiting
- Recruiting
Guangdong General Hospital
Guangzhou, Guangdong
Yong Li, Dr, yongyongsamrt@yahoo.cn
Yong Li
About this study
Official title: Phase III Study to Compared Preoperative and Postoperative With FOFLOX4 Chemotherapy and Postoperative With FOFLOX4 Chemotherapy in Patients With Resectable Liver Metastasis From Colorectal Cancer
This study is a multicenter, open-label, randomized ,controlled phase III study to compare preoperative and postoperative with FOFLOX4 chemotherapy and postoperative with FOFLOX4 chemotherapy in patients with resectable liver metastasis from colorectal cancer.
Read the detailed description
To investigate the three-year progression free survival (PFS) advantage of FOLFOX4 in the treatment of resectable metastatic colorectal cancer.
- Conditions
- Colorectal Cancer, Liver Metastasis
- Being tested
- FOFLOX4
- Keywords
- FOFLOX4, resectable liver metastasis from 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.
FOFLOX4Drug
FOLFOX4:Oxaliplatin 85mg/m2 ivgtt d1 2hr calcium leucovorin:200mg/m2 ivgtt d1 d2 2hr fluorouracil:400mg/m2 iv d1 d2 fluorouracil:600mg/m2 civ d1 d2 22hr 2 weeks repeated one cycles
| Study group | Role | What they receive |
|---|---|---|
| FOFLOX4,resectable liver metastasis from CRC | Experimental | Not described Receives: Drug: FOFLOX4 |
What is being measured
The primary outcome is the main question the study is designed to answer.
progression free survival (PFS)
Measured: 3 years
Secondary outcomes (1)
response rate, incidence of postoperative complications,pathological response rate,R0 resection rate, 5-year overall survival,duration of disease control
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2009 (estimated)
- Study startSep 2009
- Primary completionOct 2012 (estimated)
- Study completionDec 2015 (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 Guangdong Provincial People's HospitalThe 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
- 340 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangdong Provincial People's Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Feng Lin, Dr, Principal investigator, Guangdong Provincial People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01035385
- Sponsor's protocol ID
- VORP019
- Status last verified
- Sep 2009
- First submitted
- 16 Dec 2009
- Last updated
- 18 Dec 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase III Study to Compared Preoperative and Postoperative With FOFLOX4 Chemotherapy and Postoperative With FOFLOX4 Chemotherapy in Patients With Resectable Liver Metastasis From Colorectal Cancer
- ClinicalTrials.gov ID
- NCT01035385
- Acronym / sponsor ID
- VORP019
- Conditions
- Colorectal Cancer, Liver Metastasis
- Keywords
- FOFLOX4, resectable liver metastasis from colorectal cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 340 participants (estimated)
- Lead sponsor
- Guangdong Provincial People's HospitalUniversity, hospital or other
- Study start
- Sep 2009
- Primary completion
- Oct 2012 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 18 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.
This study is a multicenter, open-label, randomized ,controlled phase III study to compare preoperative and postoperative with FOFLOX4 chemotherapy and postoperative with FOFLOX4 chemotherapy in patients with resectable liver metastasis from colorectal cancer.
Detailed description
To investigate the three-year progression free survival (PFS) advantage of FOLFOX4 in the treatment of resectable metastatic colorectal cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FOFLOX4,resectable liver metastasis from CRC | Experimental | Drug: FOFLOX4 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Resectable liver metastasis from colorectal cancer(the distance from the tumor lower edge to anal more than 12cm),no visible extrahepatic metastatic tumors. Curable by resection, as determined by a surgeon and imaging physicians. The minimum of the liver metastases needs ≥2cm. Patients can be recruited if meet the conditions about:
- Age of≥18 and ≤80
- ECOG≤2
- Signed written informed consent
Key exclusion criteria (6 listed)
- Peripheral neuropathy(CTC>1)
- Had a neurological or mental disorders
- Active infection
- Allergy to Platinum-based and other drugs
- Other acute diseases including infection, heart-disease(CHF, stable or unstable angina)
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 |
|---|---|---|
| FOFLOX4FOLFOX4:Oxaliplatin 85mg/m2 ivgtt d1 2hr calcium leucovorin:200mg/m2 ivgtt d1 d2 2hr fluorouracil:400mg/m2 iv d1 d2 fluorouracil:600mg/m2 civ d1 d2 22hr 2 weeks repeated one cycles | Drug | FOFLOX4,resectable liver metastasis from CRC |
Primary outcome
progression free survival (PFS)
Time frame: 3 years
1 secondary outcome
response rate, incidence of postoperative complications,pathological response rate,R0 resection rate, 5-year overall survival,duration of disease control
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2009.
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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.
Feng Lin, Dr contact
Feng Lin, Dr principal investigator
Guangdong Provincial People's Hospital
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 FOFLOX4 in people with Colorectal Cancer and Liver Metastasis, run by Guangdong Provincial People's Hospital 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 6 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 18 Dec 2009. 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?
Contact Feng Lin, Dr (86-20-83827812-60910), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
progression free survival (PFS) (time frame: 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 18 Dec 2009.