Colorectal CancerPhase 3NCT00630045
Phase 3 Study of Surgery Combined With Neoadjuvant Chemotherapy(XELOX) in Colorectal Cancer With Resectable Liver Metastasis
A Phase 3 study testing neoadjuvant chemotherapy with oxaliplatin and capecitabine and resection of liver metastasis in people with Colorectal Cancer and Resectable Liver Metastasis, run by Peking University People's Hospital at 2 sites in China.
Trial summary
This study aims to discuss the efficacy and safety of neoadjuvant chemotherapy with XELOX regimen (oxaliplatin plus capecitabine) . Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Colorectal Cancer, Resectable Liver Metastasis
- What is being tested?
- neoadjuvant chemotherapy with oxaliplatin and capecitabine and resection of liver metastasis
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 392 participants
- Where
- 2 sitesChina
- Study dates
- Jan 2008to Jun 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed colorectal cancer with liver metastasis(all patients should have the pathological report of colorectal cancer. The chances of hepatocellular carcinoma or metastasis from other primary lesions should be excluded. )
- Liver metastasis should be resected with R0 resection and to save enough normal liver tissue
- Anticipated liver resection: for normal liver, ﹤70%; for liver with cirrhosis, ﹤50%
- No metastasis of other organs or lymph nodes in abdominal cavity
- No previous use of oxaliplatin and capecitabine, or previous adjuvant treatment ended more than 6 months
- Age 18 to 75 years old
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- Karnofsky performance status ≥70
- Life expectancy of ≥3 month
- Bilirubin level < 1.5mg/dL
- Serum creatinine <1.0 times ULN
- Absolute neutrophil count ≥2000/mm3, platelet>100,000/mm3, Hb>9g/dl
- Having signed informed consent
Who cannot join
- previous use of oxaliplatin or fluorouracil-based chemotherapy in 6 months.
- No R0 resection or not enough normal liver tissue left
- previous radiotherapy of target lesions
- accompanied with unresectable other metastasis or malignant pleural fluids or ascites.
- complete or uncompleted liver obstruction
- peripheral neuropathy(NCI-CTC grade 1 or more)
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- mental disturbance neuropathy that influence the cognition, including brain metastasis
- other serious disease such as uncontrollable active infection, heart infarction with 1 year, un controlled hypertension, arrhythmia with high risk, or unstable heart infarction,heart failure, coronary artery disease, myocardial infarction within the last 6 months
- Other previous malignancy within 5 year, except non-melanoma skin cancer
- accompany with other anti-tumor therapies,including immune therapy, intervention or injection with chemotherapeutical agents into serous cavity, or participating other clinical trials.
- Pregnancy or lactation period
Trial locations and contacts
2 sites in 1 country.
China2 sites, 2 recruiting
- Recruiting
Peking University, School of Oncology
Beijing, Beijing Municipality, 100036
Xiaotian Zhang, MD, 86-10-88196561, zhangxt@yahoo.com
jifang gong, MD, 86-10-88196088, goodjf@163.com
- Recruiting
Peking University, People's Hospital
Beijing, 100044
jing zhou, MD, 86-10-66583821, zhoujing58@sohu.com
About this study
Official title: A Phase III Study of Surgery in Combination With Neoadjuvant Chemotherapy of Oxaliplatin Plus Capecitabine in Colorectal Cancer With Respectable Liver Metastasis
This study aims to discuss the efficacy and safety of neoadjuvant chemotherapy with XELOX regimen (oxaliplatin plus capecitabine) .
Read the detailed description
Liver metastasis is the most important prognostic factor of colorectal cancer. Reasonable multidisciplinary therapy might improve the prognosis of patients with liver metastasis. Surgery has been the first choice under such situation. Recently, neoadjuvant chemotherapy has also shown its value in unresectable liver metastasis, for it can increase the chance of R0 resection and give some clues to chemosensitivity of agents. However, for those resectable lesions, the role and safety of neoadjuvant chemotherapy has yet to be confirmed. so we design this study.
- Conditions
- Colorectal Cancer, Resectable Liver Metastasis
- Being tested
- neoadjuvant chemotherapy with oxaliplatin and capecitabine, resection of liver metastasis
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
neoadjuvant chemotherapy with oxaliplatin and capecitabineDrug
oxaliplatin: 130mg/m2, d1(Q3w) capecitabine:1000mg/m2 bid, d1-14(Q3w)
resection of liver metastasisProcedure or surgery
surgery with the aim of R0 resection
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | 2~3 cycles of neoadjuvant chemotherapy before resection of liver metastasis Receives: Drug: neoadjuvant chemotherapy with oxaliplatin and capecitabine; Procedure: resection of liver metastasis |
| 2 | Active comparator | no neoadjuvant chemotherapy, resect the liver metastasis directly Receives: Procedure: resection of liver metastasis |
What is being measured
The primary outcome is the main question the study is designed to answer.
disease free survival rate
Measured: 3 year
Secondary outcomes (4)
R0 resection rate
Measured: at the time of pathological report
survival rate and over survival
Measured: 5 year
surgery related mortality
Measured: peri-operation period
response rate and safety of XELOX as a neoadjuvant regimen
Measured: no time frame
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2008 (estimated)
- Study startJan 2008
- Primary completionJun 2010 (estimated)
- Study completionJun 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 Peking University 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
- 392 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Peking University, Sanofi
- Investigators
- Shan Wang, MD, Principal investigator, Peking University People's Hospital, Department of General SurgeryLin Shen, MD, Principal investigator, Peking University, School of Oncology, Department of GI Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00630045
- Sponsor's protocol ID
- OXALIC
- Status last verified
- Feb 2008
- First submitted
- 26 Feb 2008
- Last updated
- 6 Mar 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III Study of Surgery in Combination With Neoadjuvant Chemotherapy of Oxaliplatin Plus Capecitabine in Colorectal Cancer With Respectable Liver Metastasis
- ClinicalTrials.gov ID
- NCT00630045
- Acronym / sponsor ID
- OXALIC
- Conditions
- Colorectal Cancer, Resectable Liver Metastasis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 392 participants (estimated)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Collaborators
- Peking University, Sanofi
- Study start
- Jan 2008
- Primary completion
- Jun 2010 (estimated)
- Study completion
- Jun 2015 (estimated)
- First posted
- 6 Mar 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 study aims to discuss the efficacy and safety of neoadjuvant chemotherapy with XELOX regimen (oxaliplatin plus capecitabine) .
Detailed description
Liver metastasis is the most important prognostic factor of colorectal cancer. Reasonable multidisciplinary therapy might improve the prognosis of patients with liver metastasis. Surgery has been the first choice under such situation. Recently, neoadjuvant chemotherapy has also shown its value in unresectable liver metastasis, for it can increase the chance of R0 resection and give some clues to chemosensitivity of agents. However, for those resectable lesions, the role and safety of neoadjuvant chemotherapy has yet to be confirmed. so we design this study.
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: neoadjuvant chemotherapy with oxaliplatin and capecitabine, Procedure: resection of liver metastasis2~3 cycles of neoadjuvant chemotherapy before resection of liver metastasis |
| 2 | Active comparator | Procedure: resection of liver metastasisno neoadjuvant chemotherapy, resect the liver metastasis directly |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Histologically confirmed colorectal cancer with liver metastasis(all patients should have the pathological report of colorectal cancer. The chances of hepatocellular carcinoma or metastasis from other primary lesions should be excluded. )
- Liver metastasis should be resected with R0 resection and to save enough normal liver tissue
- Anticipated liver resection: for normal liver, ﹤70%; for liver with cirrhosis, ﹤50%
- No metastasis of other organs or lymph nodes in abdominal cavity
- No previous use of oxaliplatin and capecitabine, or previous adjuvant treatment ended more than 6 months
Key exclusion criteria (11 listed)
- previous use of oxaliplatin or fluorouracil-based chemotherapy in 6 months.
- No R0 resection or not enough normal liver tissue left
- previous radiotherapy of target lesions
- accompanied with unresectable other metastasis or malignant pleural fluids or ascites.
- complete or uncompleted liver obstruction
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 |
|---|---|---|
| neoadjuvant chemotherapy with oxaliplatin and capecitabineoxaliplatin: 130mg/m2, d1(Q3w) capecitabine:1000mg/m2 bid, d1-14(Q3w) | Drug | 1 |
| resection of liver metastasissurgery with the aim of R0 resection | Procedure or surgery | 1, 2 |
Primary outcome
disease free survival rate
Time frame: 3 year
4 secondary outcomes
R0 resection rate
Time frame: at the time of pathological report
survival rate and over survival
Time frame: 5 year
surgery related mortality
Time frame: peri-operation period
response rate and safety of XELOX as a neoadjuvant regimen
Time frame: no time frame
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2008.
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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.
Shan Wang, MD principal investigator
Peking University People's Hospital, Department of General Surgery
Lin Shen, MD principal investigator
Peking University, School of Oncology, Department of GI Oncology
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing neoadjuvant chemotherapy with oxaliplatin and capecitabine and resection of liver metastasis in people with Colorectal Cancer and Resectable Liver Metastasis, run by Peking University People's Hospital at 2 sites 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 12 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: status not confirmed, as of the sponsor's last update on 6 Mar 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 zhou jing, MD (86-10-66583821, zhoujing58@sohu.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
disease free survival rate (time frame: 3 year). 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 6 Mar 2008.