Colon Cancer Liver MetastasisNCT02631564
Safety of TACE With Oxaliplatin, Irinotecan and Raltitrexed for Refractory Colorectal Cancer Liver Metastasis
An observational study of Colon Cancer Liver Metastasis, run by Fudan University at 1 site in China.
Trial summary
The purpose of this study is to observe whether hepatic infusion by oxaliplatin, irinotecan and raltitrexed with or without embolization by lipiodol or microspheres are effective in the treatment of refratory liver metastasis from colorectal cancer. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Colon Cancer Liver Metastasis
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- Jun 2015to Dec 2018
- How long will I take part?
- 12 Months
- Phase
- Observational
- 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
Study population: Refractory liver metastasis from colon and rectal cancer
Who may be able to join
- Patients must have a histologically or cytologically confirmed adenocarcinoma of the colon or rectum that is metastatic to the liver and for which standard curative measures do not exist
- Patients must have received prior irinotecan-based treatment for their disease and had documented progression by RECIST criteria; patients must also have received prior fluoropyrimidine and oxaliplatin-based therapy
- Liver disease must not be amenable to potentially curative surgical resection
- Patients must have liver-only or liver-predominant disease to be eligible for this study; hepatic disease must be dominant, but patients are allowed to have extrahepatic disease provided it is not judged likely to be life threatening within 3 months
- Patients must have a patent portal vein as documented by CT, MRI, or ultrasound
- Prior radiation therapy is allowed but must have been completed >= 4 weeks prior to study entry; patients with history of prior radiation to the liver including radio-labeled microspheres cannot take part in this study
Show all 18Show fewer
- Eastern Cooperative Oncology Group performance status 0-1
- Previous surgery or RFA to the liver is allowed; patients with history of chemoembolization or radio-labeled microspheres are excluded
- Life expectancy of >= 12 weeks
- Leukocytes >= 3,000/uL
- Absolute neutrophil count >= 1,500/uL
- Platelets >= 100,000/uL
- Total bilirubin =< ULN
- AST(SGOT)/ALT(SGPT)/Alkaline Phosphatase =< 2.5 X institutional ULN
- Creatinine < 2.0 mg/dL
- PT/PTT < 1.5 X ULN
- Women of childbearing potential (WOCBP) and sexually active males must agree to use an accepted and effective method of contraception prior to study entry and for the duration of the study; WOCBP include any female who has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation or bilateral oophorectomy) or is not postmenopausal; even women who are using oral, implanted or injectable contraceptive hormones or mechanical products such as an intrauterine device or barrier methods (diaphragm, condoms, spermicides) to prevent pregnancy or practicing abstinence or where partner is sterile (e.g., vasectomy) should be considered to be of child bearing potential
- Patients must demonstrate ability to understand and the willingness to sign a written informed consent document
Who cannot join
- Hepatic decompensation, or the presence of hepatic encephalopathy Before entering the study with gastrointestinal bleeding within 30 days
- Pregnant or nursing women may not participate in this trial because of the increased risk of fetal harm including death from the therapeutic agents
- Patients with known brain metastases are excluded from this study because of their poor prognosis and frequent development of progressive neurological dysfunction that would confound the evaluation of neurologic and other adverse events
- As patients with immune deficiency are at increased risk of lethal infections when treated with marrow-suppressive therapy, known HIV-positive patients and those with known hepatitis B or C are excluded from the study Uncontrolled intercurrent illness including, but not limited to, ongoing or active bacterial infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- Patients with clinically evident ascites requiring medical management or paracentesis, or Childs-Pugh score B/C are not eligible
- Patients with evidence of other cancer within 5 years, excluding adequately treated basal cell carcinoma of the skin
- Patient with significant cardiac, renal or hematologic or pulmonary dysfunction
- Patients with previous chemoembolization to liver metastases Patients may not receive any other anticancer therapy while on study, including immunotherapy; patients may not receive any other clinical investigational drug
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Fudan University Zhongshan Hospital
Shanghai, Shanghai Municipality, 200032
Bo Zhou, M.D,Ph.D, 8621-18616880602
About this study
Official title: An Observational Study of TACE Hepatic Arterial Infusion of Oxaliplatin, Irinotecan and Raltitrexed Treatment for Refractory Liver Metastasis From Colorectal Cancer
The purpose of this study is to observe whether hepatic infusion by oxaliplatin, irinotecan and raltitrexed with or without embolization by lipiodol or microspheres are effective in the treatment of refratory liver metastasis from colorectal cancer.
Read the detailed description
Colorectal cancer is one of most popular cancer worldwide. Patients with liver metastasis have poor prognosis except for curative resection. Chemotherapy combined biologic agents have improved mCRC median progress free survival and median overall surivival, but it is difficult to deal with liver lesions after FOLFOX and FOLFIRI treatments failed. We aim to observe the safety and efficacy of hepatic infusion and embolization of oxaliplatin, irinotecan and raltitrexed treatment for refratory liver metastasis from colorectal cancer.
- Conditions
- Colon Cancer Liver Metastasis
- Keywords
- mCRC;TACE;hepatic infusion;raltitrexed
What is being measured
The primary outcome is the main question the study is designed to answer.
number of adverse events
Measured: 6 months
Secondary outcomes (2)
Overall survival
Measured: 2 years
Time to progression
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2015 (estimated)
- Study startJun 2015
- Primary completionJun 2017 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colon Cancer Liver MetastasisStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bo Zhou, Fudan University
- Investigators
- Bo Zhou, M.D,Ph.D, Principal investigator, Shanghai Zhongshan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02631564
- Sponsor's protocol ID
- Ral-1
- Status last verified
- Dec 2015
- First submitted
- 14 Dec 2015
- Last updated
- 16 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational Study of TACE Hepatic Arterial Infusion of Oxaliplatin, Irinotecan and Raltitrexed Treatment for Refractory Liver Metastasis From Colorectal Cancer
- ClinicalTrials.gov ID
- NCT02631564
- Acronym / sponsor ID
- Ral-1
- Conditions
- Colon Cancer Liver Metastasis
- Keywords
- mCRC;TACE;hepatic infusion;raltitrexed
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- Jun 2015
- Primary completion
- Jun 2017 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 16 Dec 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 is to observe whether hepatic infusion by oxaliplatin, irinotecan and raltitrexed with or without embolization by lipiodol or microspheres are effective in the treatment of refratory liver metastasis from colorectal cancer.
Detailed description
Colorectal cancer is one of most popular cancer worldwide. Patients with liver metastasis have poor prognosis except for curative resection. Chemotherapy combined biologic agents have improved mCRC median progress free survival and median overall surivival, but it is difficult to deal with liver lesions after FOLFOX and FOLFIRI treatments failed. We aim to observe the safety and efficacy of hepatic infusion and embolization of oxaliplatin, irinotecan and raltitrexed treatment for refratory liver metastasis from colorectal cancer.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Refractory liver metastasis from colon and rectal cancer
Key inclusion criteria (18 listed)
- Patients must have a histologically or cytologically confirmed adenocarcinoma of the colon or rectum that is metastatic to the liver and for which standard curative measures do not exist
- Patients must have received prior irinotecan-based treatment for their disease and had documented progression by RECIST criteria; patients must also have received prior fluoropyrimidine and oxaliplatin-based therapy
- Liver disease must not be amenable to potentially curative surgical resection
- Patients must have liver-only or liver-predominant disease to be eligible for this study; hepatic disease must be dominant, but patients are allowed to have extrahepatic disease provided it is not judged likely to be life threatening within 3 months
- Patients must have a patent portal vein as documented by CT, MRI, or ultrasound
Key exclusion criteria (8 listed)
- Hepatic decompensation, or the presence of hepatic encephalopathy Before entering the study with gastrointestinal bleeding within 30 days
- Pregnant or nursing women may not participate in this trial because of the increased risk of fetal harm including death from the therapeutic agents
- Patients with known brain metastases are excluded from this study because of their poor prognosis and frequent development of progressive neurological dysfunction that would confound the evaluation of neurologic and other adverse events
- As patients with immune deficiency are at increased risk of lethal infections when treated with marrow-suppressive therapy, known HIV-positive patients and those with known hepatitis B or C are excluded from the study Uncontrolled intercurrent illness including, but not limited to, ongoing or active bacterial infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- Patients with clinically evident ascites requiring medical management or paracentesis, or Childs-Pugh score B/C are not eligible
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
number of adverse events
Time frame: 6 months
2 secondary outcomes
Overall survival
Time frame: 2 years
Time to progression
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2015.
- Individual participant dataSharing planned: Undecided
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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.
Bo Zhou, M.D,Ph.D principal investigator
Shanghai Zhongshan Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colon Cancer Liver Metastasis, run by Fudan University 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 18 inclusion and 8 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 16 Dec 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.
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 Bo Zhou, M.D, Ph.D (8621-18616880602, bonheurzhou@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
number of adverse events (time frame: 6 months). 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 16 Dec 2015.