Resected Liver Metastases From Colorectal CancerPhase 2/3NCT02529774
Alternating Systemic and Hepatic Artery Infusion Therapy As Adjuvant Treatment After Resection of Liver Metastases From Colorectal Cancer
A Phase 2/3 study testing Floxuridine (FUDR),Dexamethasone (DXM), Heparin in combination with Oxaliplatin and Capecitabine (CapeOX) or in combination with Oxaliplatin and Leucovorin and 5-FU (mFOLFOX6) and Oxaliplatin and Capecitabine (CapeOX) or Oxaliplatin and Leucovorin and 5-FU (mFOLFOX6) in people with Resected Liver Metastases From Colorectal Cancer, run by Ye Xu at 1 site in China.
Trial summary
This adaptive seamless Phase II/III trial is to compare the efficacy and safety of adjuvant systemic chemotherapy (SCT) with or without hepatic arterial infusion (HAI) after complete hepatic resection for Chinese patients with metastatic colorectal cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Resected Liver Metastases From Colorectal Cancer
- What is being tested?
- Floxuridine (FUDR),Dexamethasone (DXM), Heparin in combination with Oxaliplatin and Capecitabine (CapeOX) or in combination with Oxaliplatin and Leucovorin and 5-FU (mFOLFOX6) and Oxaliplatin and Capecitabine (CapeOX) or Oxaliplatin and Leucovorin and 5-FU (mFOLFOX6)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 432 participants
- Where
- 1 siteChina
- Study dates
- Sep 2015to Sep 2021
- Phase
- Phase 2/3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Diagnosis Criteria:
All patients should have histologically confirmed colorectal adenocarcinoma with hepatic metastases and primary tumours completely resected during the operation and with colorectal metastatic to the liver confirmed pathologically after the operation as well as with negative surgical margin.
Main criteria for inclusion:
- Aged 18-75 years
- Diagnosed as colorectal adenocarcinoma which only spread to the liver and with no extra-hepatic metastases
- Prior curative resection of primary tumours (R0 resection) or concurrent feasible curative resection of primary tumours and hepatic metastases (R0 resection is met)
- Performance status ECOG 0-1
- No serious complication occurred during or after metastases resection and affected subsequent treatment.
- Hematology: White blood count ≧ 4.0X10^9/L, Absolute neutrophil count ≧1.5X10^9/L, Platelet count ≧ 100 X10^9/L, Hemoglobin ≧ 100g/L
- Blood biochemistry: Total bilirubin ≦2mg/dL , Direct bilirubin equal or less than 1.5 times upper limit of normal (ULN), Alanine aminotransferase (ALT) no greater than 2.5 times ULN, Aspartate aminotransferase (AST) no greater than 2.5 times ULN, Serum creatinine no greater than ULN, or glomerular filtration rate equal or greater than 60 mL/min/1.73m^2
- Not pregnant or nursing at present
- Fertile patients must use effective contraception
- Able to withstand major operative procedure
- No prior or concurrent malignancy within the past 5 years except basal cell or squamous cell skin cancer or carcinoma in situ of any organ
- No prior hepatic artery infusion therapy with 5-FU or floxuridine
- No prior systemic chemotherapy for metastatic disease
- No other concurrent chemotherapy
- Able to understand and sign off informed consent form
Trial locations and contacts
1 site in 1 country.
China1 site
Fudan University Shanghai Cancer Center China
Shanghai, Shanghai Municipality, 200032
Ye Xu, Dr., +86 21 64175590, xu_shirley021@163.com
Hongtu Zheng, Dr., +86 180 1731 7711, zht5863@126.com
About this study
Official title: Efficacy and Safety of Alternating Systemic and Hepatic Artery Infusion Therapy Versus Systemic Chemotherapy Alone As Adjuvant Treatment After Resection of Liver Metastases From Colorectal Cancer: A Randomized, Parallel-Group, Open-Labelled, Active-Controlled Phase II/III Trial in China
This adaptive seamless Phase II/III trial is to compare the efficacy and safety of adjuvant systemic chemotherapy (SCT) with or without hepatic arterial infusion (HAI) after complete hepatic resection for Chinese patients with metastatic colorectal cancer.
- Being tested
- Floxuridine (FUDR),Dexamethasone (DXM), Heparin in combination with Oxaliplatin and Capecitabine (CapeOX) or in combination with Oxaliplatin and Leucovorin and 5-FU (mFOLFOX6), Oxaliplatin and Capecitabine (CapeOX) or Oxaliplatin and Leucovorin and 5-FU (mFOLFOX6)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Floxuridine (FUDR),Dexamethasone (DXM), Heparin in combination with Oxaliplatin and Capecitabine (CapeOX) or in combination with Oxaliplatin and Leucovorin and 5-FU (mFOLFOX6)Drug
Hepatic Artery Infusion for four cycles:
Floxuridine (FUDR) 500mg/d, Day 1-2; DXM 1mg/day added to FUDR 2-day infusion; Heparin 1000U/day added to FUDR 2-day infusion
In combination with Systemic Chemotherapy CapeOX for 8 cycles:
Oxaliplatin 130 mg/m^2 iv over 2 hours, Day 1. Capecitabine 850mg/m^2/d PO Bid, given in the morning and evening, Day 1-14
Or in combination with Systemic Chemotherapy mFOLFOX6 for 12 cycles:
Oxaliplatin 85mg/m^2 IV over 2 hours, Day 1. Leucovorin 400mg/m^2 IV over 2 hours, Day 1 5-fluorouracil (FU) 400mg/m^2 IV and then 2400mg/m^2 over 48 hours IV continuous infusion. Day 1
Oxaliplatin and Capecitabine (CapeOX) or Oxaliplatin and Leucovorin and 5-FU (mFOLFOX6)Drug
Systemic Chemotherapy CapeOX alone for 8 cycles:
Oxaliplatin 130 mg/m^2 iv over 2 hours, Day 1. Capecitabine 850mg/m^2/d PO Bid, given in the morning and evening, Day 1-14
Or Systemic Chemotherapy mFOLFOX6 alone for 12 cycles:
Oxaliplatin 85mg/m^2 IV over 2 hours, Day 1. Leucovorin 400mg/m^2 IV over 2 hours, Day 1 5-fluorouracil (FU) 400mg/m^2 IV and then 2400mg/m^2 over 48 hours IV continuous infusion. Day 1
| Study group | Role | What they receive |
|---|---|---|
| Systemic Chemotherapy plus Hepatic Artery Infusion (HAI) | Experimental | Not described Receives: Drug: Floxuridine (FUDR),Dexamethasone (DXM), Heparin in combination with Oxaliplatin and Capecitabine (CapeOX) or in combination with Oxaliplatin and Leucovorin and 5-FU (mFOLFOX6) |
| Systemic Chemotherapy | Active comparator | Not described Receives: Drug: Oxaliplatin and Capecitabine (CapeOX) or Oxaliplatin and Leucovorin and 5-FU (mFOLFOX6) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival
Overall survival will be measured from the date of randomization up to the date of death of any cause
Measured: 5-year
Liver Relapse-Free Survival Rate
Liver Relapse-Free Survival (LRFS) is defined as the interval from the date of randomization to the date of liver localized metastatic relapse (with the exception of curatively treated non-melanoma skin cancer or carcinoma in situ of the cervix) or death from any cause whichever occurs first.
Measured: 3-year
Secondary outcomes (1)
Disease free survival
DFS is defined as the time interval from the date of randomization to the time of the first relapse at any site, death from any cause, or last recorded follow-up visit.
Measured: 3-year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2015 (estimated)
- Study startSep 2015
- Primary completionSep 2020 (estimated)
- Study completionSep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Resected Liver Metastases From Colorectal CancerStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 432 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ye Xu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ye Xu, Fudan University
- Investigators
- Ye Xu, Dr., Principal investigator, Fudan University Shanghai Cancer Center China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02529774
- Sponsor's protocol ID
- 1507149-6
- Status last verified
- Aug 2015
- First submitted
- 18 Aug 2015
- Last updated
- 20 Aug 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Alternating Systemic and Hepatic Artery Infusion Therapy Versus Systemic Chemotherapy Alone As Adjuvant Treatment After Resection of Liver Metastases From Colorectal Cancer: A Randomized, Parallel-Group, Open-Labelled, Active-Controlled Phase II/III Trial in China
- ClinicalTrials.gov ID
- NCT02529774
- Acronym / sponsor ID
- 1507149-6
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 432 participants (estimated)
- Lead sponsor
- Ye XuUniversity, hospital or other
- Study start
- Sep 2015
- Primary completion
- Sep 2020 (estimated)
- Study completion
- Sep 2021 (estimated)
- First posted
- 20 Aug 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.
This adaptive seamless Phase II/III trial is to compare the efficacy and safety of adjuvant systemic chemotherapy (SCT) with or without hepatic arterial infusion (HAI) after complete hepatic resection for Chinese patients with metastatic colorectal cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Systemic Chemotherapy plus Hepatic Artery Infusion (HAI) | Experimental | Drug: Floxuridine (FUDR),Dexamethasone (DXM), Heparin in combination with Oxaliplatin and Capecitabine (CapeOX) or in combination with Oxaliplatin and Leucovorin and 5-FU (mFOLFOX6) |
| Systemic Chemotherapy | Active comparator | Drug: Oxaliplatin and Capecitabine (CapeOX) or Oxaliplatin and Leucovorin and 5-FU (mFOLFOX6) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Floxuridine (FUDR),Dexamethasone (DXM), Heparin in combination with Oxaliplatin and Capecitabine (CapeOX) or in combination with Oxaliplatin and Leucovorin and 5-FU (mFOLFOX6)Hepatic Artery Infusion for four cycles: Floxuridine (FUDR) 500mg/d, Day 1-2; DXM 1mg/day added to FUDR 2-day infusion; Heparin 1000U/day added to FUDR 2-day infusion In combination with Systemic Chemotherapy CapeOX for 8 cycles: Oxaliplatin 130 mg/m^2 iv over 2 hours, Day 1. Capecitabine 850mg/m^2/d PO Bid, given in the morning and evening, Day 1-14 Or in combination with Systemic Chemotherapy mFOLFOX6 for 12 cycles: Oxaliplatin 85mg/m^2 IV over 2 hours, Day 1. Leucovorin 400mg/m^2 IV over 2 hours, Day 1 5-fluorouracil (FU) 400mg/m^2 IV and then 2400mg/m^2 over 48 hours IV continuous infusion. Day 1 | Drug | Systemic Chemotherapy plus Hepatic Artery Infusion (HAI) |
| Oxaliplatin and Capecitabine (CapeOX) or Oxaliplatin and Leucovorin and 5-FU (mFOLFOX6)Systemic Chemotherapy CapeOX alone for 8 cycles: Oxaliplatin 130 mg/m^2 iv over 2 hours, Day 1. Capecitabine 850mg/m^2/d PO Bid, given in the morning and evening, Day 1-14 Or Systemic Chemotherapy mFOLFOX6 alone for 12 cycles: Oxaliplatin 85mg/m^2 IV over 2 hours, Day 1. Leucovorin 400mg/m^2 IV over 2 hours, Day 1 5-fluorouracil (FU) 400mg/m^2 IV and then 2400mg/m^2 over 48 hours IV continuous infusion. Day 1 | Drug | Systemic Chemotherapy |
Primary outcome
Overall Survival
Time frame: 5-year
Overall survival will be measured from the date of randomization up to the date of death of any cause
Liver Relapse-Free Survival Rate
Time frame: 3-year
Liver Relapse-Free Survival (LRFS) is defined as the interval from the date of randomization to the date of liver localized metastatic relapse (with the exception of curatively treated non-melanoma skin cancer or carcinoma in situ of the cervix) or death from any cause whichever occurs first.
1 secondary outcome
Disease free survival
Time frame: 3-year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2015.
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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.
Ye Xu, Dr. principal investigator
Fudan University Shanghai Cancer Center China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Floxuridine (FUDR),Dexamethasone (DXM), Heparin in combination with Oxaliplatin and Capecitabine (CapeOX) or in combination with Oxaliplatin and Leucovorin and 5-FU (mFOLFOX6) and Oxaliplatin and Capecitabine (CapeOX) or Oxaliplatin and Leucovorin and 5-FU (mFOLFOX6) in people with Resected Liver Metastases From Colorectal Cancer, run by Ye 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?
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 20 Aug 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 combined 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.
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 Ye Xu, Dr. (+86 21 64175590, xu_shirley021@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Survival (time frame: 5-year). The study lists 2 primary outcomes in all. 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 20 Aug 2015.