Potentially Resectable Liver Metastasis From CRCPhase 2NCT00997685
Evaluate Efficacy and Safety of XELOX in Potentially Resectable Liver Metastasis From Colorectal Cancer(CRC)
A Phase 2 study testing Capecitabine plus oxaliplatin in people with Potentially Resectable Liver Metastasis From CRC and Colorectal Cancer, run by Guangdong Provincial People's Hospital at 1 site in China.
Trial summary
This is a single arm, open-label phase II study to evaluate the efficacy and safety of Capecitabine plus oxaliplatin (XELOX) in the peri-operative treatment of patients with potentially resectable liver metastasis from colorectal cancer. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Potentially Resectable Liver Metastasis From CRC, Colorectal Cancer
- What is being tested?
- Capecitabine plus oxaliplatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteChina
- Study dates
- Nov 2009to Oct 2015
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age of 18 and 65
- Histologically confirmed colorectal cancer and two methords of imaging detection confirmed liver metastasis
- Potentially curable by resection, as determined by a surgeon with hepatic surgery expertise
- No evidence of extrahepatic disease by chest x-ray or CT scan of the chest, abdomen, and pelvis
- Patients with adequate hepative, renal and bone marrow function
- Signed written informed consent
Who cannot join
- Pregnant or nursing patients (fertile patients must use effective contraception)
- Other malignancy within the past 5 years except completely resected nonmelanoma skin cancer or carcinoma in situ of the cervix
- Preexisting grade 2 or greater peripheral neuropathy
- Concurrent uncontrolled illness
- Ongoing or active infection
- Psychiatric illness or social situation that would preclude study compliance
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- Less than 6 months since prior adjuvant fluorouracil-based chemotherapy
- Prior chemotherapy for liver metastasis
- Prior oxaliplatin for colorectal cancer
- Prior or concurrent hepatic artery infusion chemotherapy for metastatic disease
- Prior or concurrent radiotherapy for metastatic disease
- Prior or concurrent radiofrequency ablation for metastatic disease
- concurrent treatment with any other anti-cancer therapy.
Trial locations and contacts
1 site in 1 country.
Feng Lin, Dr contact
China1 site
Guangdong General Hospital
Guangzhou, Guangdong, 510080
Yong Li, Dr, yongyongsamrt@yahoo.cn
Feng Lin
About this study
Official title: A Single Arm, Open-label Phase II Study to Evaluate the Efficacy and Safety of Capecitabine Plus Oxaliplatin (XELOX) in the Peri-operative Treatment of Patients With Potentially Resectable Liver Metastasis From Colorectal Cancer
This is a single arm, open-label phase II study to evaluate the efficacy and safety of Capecitabine plus oxaliplatin (XELOX) in the peri-operative treatment of patients with potentially resectable liver metastasis from colorectal cancer.
Read the detailed description
To investigate the progression free survival (PFS) advantage of Xeloda plus oxaliplatin in the peri-operative treatment of potential resectable metastatic colorectal cancer
- Being tested
- Capecitabine plus oxaliplatin
- Keywords
- XELOX, potentially resectable liver metastasis from CRC
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Capecitabine plus oxaliplatinDrug
Also called XELOX
Xeloda: 1000mg/m2 bid, d1-14, q3w, Oxaliplatin:130mg/m2 d1, q3w,
4 pre-operative cycles, 4 post-operative cycles
| Study group | Role | What they receive |
|---|---|---|
| Capecitabine plus oxaliplatin，mCRC | Experimental | Not described Receives: Drug: Capecitabine plus oxaliplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
To investigate the progression free survival (PFS) advantage of Xeloda plus oxaliplatin in the peri-operative treatment of potential resectable metastatic colorectal cancer
Measured: 3.6 years
Secondary outcomes (3)
To investigate the response rate
Measured: 3.6 years
To evaluate the R0 resection rate
Measured: 3.6 years
To evaluate the safety profile of XELOX peri-operative treatment
Measured: 3.6 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2009 (estimated)
- Study startNov 2009
- Primary completionOct 2015 (estimated)
- Study completionOct 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Potentially Resectable Liver Metastasis From CRCStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangdong Provincial People's Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Feng Lin, Principal investigator, Guangdong Provincial People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00997685
- Sponsor's protocol ID
- ML22298
- Status last verified
- Oct 2009
- First submitted
- 18 Oct 2009
- Last updated
- 19 Oct 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Arm, Open-label Phase II Study to Evaluate the Efficacy and Safety of Capecitabine Plus Oxaliplatin (XELOX) in the Peri-operative Treatment of Patients With Potentially Resectable Liver Metastasis From Colorectal Cancer
- ClinicalTrials.gov ID
- NCT00997685
- Acronym / sponsor ID
- ML22298
- Keywords
- XELOX, potentially resectable liver metastasis from CRC
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Guangdong Provincial People's HospitalUniversity, hospital or other
- Study start
- Nov 2009
- Primary completion
- Oct 2015 (estimated)
- Study completion
- Oct 2015 (estimated)
- First posted
- 19 Oct 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 is a single arm, open-label phase II study to evaluate the efficacy and safety of Capecitabine plus oxaliplatin (XELOX) in the peri-operative treatment of patients with potentially resectable liver metastasis from colorectal cancer.
Detailed description
To investigate the progression free survival (PFS) advantage of Xeloda plus oxaliplatin in the peri-operative treatment of potential resectable metastatic colorectal cancer
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Capecitabine plus oxaliplatin，mCRC | Experimental | Drug: Capecitabine plus oxaliplatin |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age of 18 and 65
- Histologically confirmed colorectal cancer and two methords of imaging detection confirmed liver metastasis
- Potentially curable by resection, as determined by a surgeon with hepatic surgery expertise
- No evidence of extrahepatic disease by chest x-ray or CT scan of the chest, abdomen, and pelvis
- Patients with adequate hepative, renal and bone marrow function
Key exclusion criteria (13 listed)
- Pregnant or nursing patients (fertile patients must use effective contraception)
- Other malignancy within the past 5 years except completely resected nonmelanoma skin cancer or carcinoma in situ of the cervix
- Preexisting grade 2 or greater peripheral neuropathy
- Concurrent uncontrolled illness
- Ongoing or active infection
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 |
|---|---|---|
| Capecitabine plus oxaliplatinAlso: XELOXXeloda: 1000mg/m2 bid, d1-14, q3w, Oxaliplatin:130mg/m2 d1, q3w, 4 pre-operative cycles, 4 post-operative cycles | Drug | Capecitabine plus oxaliplatin，mCRC |
Primary outcome
To investigate the progression free survival (PFS) advantage of Xeloda plus oxaliplatin in the peri-operative treatment of potential resectable metastatic colorectal cancer
Time frame: 3.6 years
3 secondary outcomes
To investigate the response rate
Time frame: 3.6 years
To evaluate the R0 resection rate
Time frame: 3.6 years
To evaluate the safety profile of XELOX peri-operative treatment
Time frame: 3.6 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2009.
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 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 2 study testing Capecitabine plus oxaliplatin in people with Potentially Resectable Liver Metastasis From CRC and Colorectal Cancer, 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 13 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 19 Oct 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Feng Lin, Dr (+8613903018609), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To investigate the progression free survival (PFS) advantage of Xeloda plus oxaliplatin in the peri-operative treatment of potential resectable metastatic colorectal cancer (time frame: 3.6 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 19 Oct 2009.