Colon Cancer Liver MetastasisPhase 4NCT02557490
Oxaliplatin and Raltitrexed Treatment of Colorectal Cancer With Liver Metastases
A Phase 4 study testing oxaliplatin and raltitrexed in people with Colon Cancer Liver Metastasis, run by Zhu Xu at 1 site in China.
Trial summary
The purpose of this study was a randomized controlled trial to compare the effect of oxaliplatin and raltitrexed treatment of colorectal cancer with liver metastases by TACE hepatic artery infusion Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Colon Cancer Liver Metastasis
- What is being tested?
- oxaliplatin and raltitrexed
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- Jan 2015to Dec 2017
- Phase
- Phase 4
- 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
- With written informed consent
- Age ranged from 18 to 80 years, both men and women
- Confirmed by pathology or clinical diagnosis of unresectable colorectal cancer with liver metastases patients(including the primary tumor and liver in patients with brain metastases except outside of metastasis in patients with unresectable)
- Progress systemic chemotherapy or who can not tolerate chemotherapy, or who refuse chemotherapy
- Never received TACE treatment
- (M) RECIST 1.0 criteria measurable liver lesions at several ≥2, each lesion diameter ≥3 cm long and ≤20cm,
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- ECOG PS score of ≤2
- expected survival time ≥12 weeks
- The test results before 7 days entered the group must meet the following requirements:
- Hemoglobin ≥ 90 g / L
- Absolute neutrophil count (ANC)> 1,500 / mm3
- Platelet count ≥ 80x109 / L
- Serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) <5 times the upper limit of normal (UNL)
- Total bilirubin <3UNL
- Serum creatinine <1.5 UNL
- PT or INR, PPT <1.5 UNL (for patients undergoing warfarin or heparin anticoagulant therapy, if there is no evidence that there is an abnormality of the above parameters, you can enter the group, but must be closely monitored to detect at least once a week until the INR stable)
Who cannot join
- Specific circumstances of patients not suitable for TACE therapy / chemotherapy
- Hepatic decompensation, or the presence of hepatic encephalopathy
- Before entering the study with gastrointestinal bleeding within 30 days
- Presence of brain metastasis
- Pregnant or lactating women
- Active bleeding or sepsis
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- History of heart disease:
- NYHA two or more of congestive heart failure, symptomatic coronary artery disease
- Need to use β-blockers or digoxin medication other than arrhythmias
- Despite treatment, still systolic blood pressure> 150 mmHg or diastolic blood pressure> 90 mmHg hypertension
- Not cure severe trauma, acute or incurable ulcer, or three months fracture
- The researchers believe their poor compliance
- Exist once or primary lesion or histologically different tumors and colorectal cancer, except: head and neck carcinoma in situ, cured basal cell carcinoma, superficial bladder cancer (Ta, Tis, T1), and the group 3 years ago, it has been cured of cancer
- HIV infection or the presence of AIDS-related illness, or severe acute and chronic diseases
- Drug abuse, or suffering that could interfere with study compliance and other psychological or psychiatric disorders
- Need drug therapy epilepsy (such as steroids or antiepileptic drugs
- Chemotherapy contraindications exist
- Any instability or likely to endanger the patient in this study the safety and compliance of the case
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Beijing Cancer Hospital
Beijing, Beijing Municipality, 100142
Zhu Xu, Master, 0086-10-88195476, zhux387@263.net
Zhu Xu, Master
About this study
Official title: A Randomized Controlled Trial of TACE Hepatic Artery Infusion of Oxaliplatin and Raltitrexed Treatment of Colorectal Cancer With Liver Metastases
The purpose of this study was a randomized controlled trial to compare the effect of oxaliplatin and raltitrexed treatment of colorectal cancer with liver metastases by TACE hepatic artery infusion
Read the detailed description
Colorectal cancer is one of the most common malignancies, with 1 million new cases and half a million deaths each year worldwide. The development of metastases is the main cause of death. Liver metastases are diagnosed in 10-25% of patients at the time of resection of their primary colorectal tumor and, eventually, up to 70% of patients with colorectal cancer develop liver metastases.Oxaliplatin and raltitrexed were used for the treatment of colorectal cancer with liver metastases. We aimed to perform a randomized controlled trial to compare the effect of oxaliplatin and raltitrexed treatment of colorectal cancer with liver metastases by TACE hepatic artery infusion.
- Conditions
- Colon Cancer Liver Metastasis
- Being tested
- oxaliplatin and raltitrexed
- Keywords
- TACE; hepatic artery infusion; oxaliplatin; raltitrexed
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oxaliplatin and raltitrexedDrug
TACE methods: use of epirubicin 20-40mg emulsifier lipiodol embolization target vessel, with gelatin sponge particles or PVA particles or microspheres embolization supplement.
Hepatic arterial chemotherapy: Bi embolization catheter in the hepatic artery or left hepatic artery branch within the right, chemotherapy, for the experimental group (A group): OXA 130mg / m2 artery 0-4 hours pumped Raltitrexed 3mg/m2 4-5 hours pumped into the arteries; the control group (group B)
| Study group | Role | What they receive |
|---|---|---|
| Oxaliplatin by TACE | Experimental | Oxaliplatin for the therapy of Colorectal Cancer With Liver Metastases by TACE.No interventions was raltitrexed for the therapy of Colorectal Cancer With Liver Metastases by TACE. Receives: Drug: oxaliplatin and raltitrexed |
| Raltitrexed by TACE | No intervention | Raltitrexed for the therapy of Colorectal Cancer With Liver Metastases by TACE. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival (PFS)
Measured: three years
Secondary outcomes (1)
overall survival (OS)
Measured: three years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2015 (estimated)
- Study startJan 2015
- Primary completionDec 2016 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colon Cancer Liver MetastasisStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhu Xu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Zhu Xu, Peking University Cancer Hospital & Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02557490
- Sponsor's protocol ID
- 2014YJZ16
- Status last verified
- Jul 2015
- First submitted
- 22 Sep 2015
- Last updated
- 23 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Feng AW, Guo JH, Gao S, Kou FX, Liu SX, Liu P, Chen H, Wang XD, Xu HF, Cao G, Zhu X. A randomized phase II trial of hepatic arterial infusion of oxaliplatin plus raltitrexed versus oxaliplatin plus 5-fluorouracil for unresectable colorectal cancer liver metastases. Front Oncol. 2022 Sep 21;12:913017. doi: 10.3389/fonc.2022.913017. eCollection 2022.
PubMed 36212504
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of TACE Hepatic Artery Infusion of Oxaliplatin and Raltitrexed Treatment of Colorectal Cancer With Liver Metastases
- ClinicalTrials.gov ID
- NCT02557490
- Acronym / sponsor ID
- 2014YJZ16
- Conditions
- Colon Cancer Liver Metastasis
- Keywords
- TACE; hepatic artery infusion; oxaliplatin; raltitrexed
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Zhu XuUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 23 Sep 2015 (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.
The purpose of this study was a randomized controlled trial to compare the effect of oxaliplatin and raltitrexed treatment of colorectal cancer with liver metastases by TACE hepatic artery infusion
Detailed description
Colorectal cancer is one of the most common malignancies, with 1 million new cases and half a million deaths each year worldwide. The development of metastases is the main cause of death. Liver metastases are diagnosed in 10-25% of patients at the time of resection of their primary colorectal tumor and, eventually, up to 70% of patients with colorectal cancer develop liver metastases.Oxaliplatin and raltitrexed were used for the treatment of colorectal cancer with liver metastases. We aimed to perform a randomized controlled trial to compare the effect of oxaliplatin and raltitrexed treatment of colorectal cancer with liver metastases by TACE hepatic artery infusion.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oxaliplatin by TACE | Experimental | Drug: oxaliplatin and raltitrexedOxaliplatin for the therapy of Colorectal Cancer With Liver Metastases by TACE.No interventions was raltitrexed for the therapy of Colorectal Cancer With Liver Metastases by TACE. |
| Raltitrexed by TACE | No intervention | –Raltitrexed for the therapy of Colorectal Cancer With Liver Metastases by TACE. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- With written informed consent
- Age ranged from 18 to 80 years, both men and women
- Confirmed by pathology or clinical diagnosis of unresectable colorectal cancer with liver metastases patients(including the primary tumor and liver in patients with brain metastases except outside of metastasis in patients with unresectable)
- Progress systemic chemotherapy or who can not tolerate chemotherapy, or who refuse chemotherapy
- Never received TACE treatment
Key exclusion criteria (18 listed)
- Specific circumstances of patients not suitable for TACE therapy / chemotherapy
- Hepatic decompensation, or the presence of hepatic encephalopathy
- Before entering the study with gastrointestinal bleeding within 30 days
- Presence of brain metastasis
- Pregnant or lactating women
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 and raltitrexedTACE methods: use of epirubicin 20-40mg emulsifier lipiodol embolization target vessel, with gelatin sponge particles or PVA particles or microspheres embolization supplement. Hepatic arterial chemotherapy: Bi embolization catheter in the hepatic artery or left hepatic artery branch within the right, chemotherapy, for the experimental group (A group): OXA 130mg / m2 artery 0-4 hours pumped Raltitrexed 3mg/m2 4-5 hours pumped into the arteries; the control group (group B) | Drug | Oxaliplatin by TACE |
Primary outcome
Progression-free survival (PFS)
Time frame: three years
1 secondary outcome
overall survival (OS)
Time frame: three years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2015.
- Derived from this study: PubMed 36212504Feng AW, Guo JH, Gao S, Kou FX, Liu SX, Liu P, Chen H, Wang XD, Xu HF, Cao G, Zhu X. A randomized phase II trial of hepatic arterial infusion of oxaliplatin plus raltitrexed versus oxaliplatin plus 5-fluorouracil for unresectable colorectal cancer liver metastases. Front Oncol. 2022 Sep 21;12:913017. doi: 10.3389/fonc.2022.913017. eCollection 2022.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing oxaliplatin and raltitrexed in people with Colon Cancer Liver Metastasis, run by Zhu Xu 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 16 inclusion and 18 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 23 Sep 2015. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival (PFS) (time frame: three years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02557490, which also lists 1 linked publication.
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 23 Sep 2015.