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Metastatic Colorectal CancerPhase 3NCT03678428

FUDR/Oxaliplatin HAI Plus Irinotecan vs. FOLFOXIRI Chemotherapy in Treating Initially Unresectable CRCLM

A Phase 3 study testing Irinotecan, Oxaliplatin HAI and Floxuridine in people with Metastatic Colorectal Cancer and Liver Metastases, run by Sun Yat-sen University at 1 site in China.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

The aim of the trial is to compare the objective response rates of FUDR/Oxaliplatin HAI plus CPT-11 and FOLFOXIRI chemotherapy in patients with initially non-resectable metastatic colorectal cancer liver metastases. Read more about this study

Who is it for?
Ages 18 to 70 years
What is being tested?
Irinotecan, Oxaliplatin HAI and Floxuridine
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
92 participants
Where
1 siteChina
Study dates
31 Dec 2021to 31 Dec 2022
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 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age ≥ 18 and ≤70.
  • Diagnosed as colorectal adenocarcinoma by histology.
  • Confirmed as liver metastases by medical imaging or pathology.
  • MDT determined as unresectable liver metastases, defined as:①more than 5 metastases; ②unable to conduct R0 resection; ③no sufficient residual liver volume after resection; ④none of 3 hepatic vein can be reserved after resection, no sufficient blood supply or bibliary duct can be reserved, none of 2 adjacent liver segment can be reserved. Whenever meets any of the criteria mentioned above would be defined as unresectable liver metastases.
  • No previous treatment aiming at treating liver metastases, including chemotherapy, surgery, radiotherapy, transcatheter hepatic arterial chemoembolization(TACE) or target therapy.
  • Confirmed by CT, MRI or PET/CT(if necessary) that there is no extrahepatic metastases or only oligos extrahepatic metastases(no more than 2 organs and 5 leisions, maximum diameters of single leision ≤ 1cm).
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  • Unsuitable for cetuximab treatment(RAS mutation, unable to afford the cost).
  • No hematologic dysfunction(Platelets >90×10^9/L; WBC >3×10^9/L; Neutrophil >1.5×109/L).
  • Serum bilirubin ≤ 1.5 × ULN; aminotransferase ≤ 5 × ULN.
  • No ascites; no coagulation dysfunction; albumin ≥ 30g/L.
  • Hepatic function was classified as class A by Child-Pugh classification.
  • Serum creatinine < 1 × ULN, or creatinine clearance rate(CCR) > 50ml/min(calculated by Cockcroft-Gault formula).
  • ECOG scored as 0-1.
  • Life expectancy > 3 months.
  • Informed consent.
  • Willing and able to receive follow-up until death or trial is finished or trial is terminated.

Who cannot join

  • Presence of extensive extrahepatic metastases(more than 2 organs and 5 leisions, or maximum diameter of single leision > 10 cm).
  • Severe arterial embolism or ascites.
  • Presence of hemorrhagic tendency or coagulation dysfunction.
  • Presentive of hypertensive crisis or hypertensive encephalopathy.
  • Severe uncontrolled systemic complications, such as infection or diabetes.
  • Severe clinical CVD(cardiovascular disease), such as cerebrovascular accident(within 6 months before recruitment), myocardial infarction(within 6 months before recruitment), uncontrolled hypertension; unstable angina pectoris; congestive heart-failure(NYHA 2-4 grade); arrhythmia that needs medication treatment.
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  • Previous diagnosed or physical examination showed presence of central nervous system(CNS) disease(i.e. primary brain tumor, epilepsy uncontrolled by standard treatment, any history of brain metastases or stroke).
  • Previous history of other malignancy within 5 years(except basal cell carcinoma after radical resection and/or cervical carcinoma in situ).
  • Received any medication under research within 28 days before the trial.
  • Any residual toxicity of previous chemotherapy(except hair loss), i.e. peripheral neuropathy ≥ NCI CTC v3.0 Grade 2, will be excluded from oxaliplatin-based chemotherapy regimen research pair.
  • Allergic to any medication involved in the trial.
  • Pregnant and lactating women.
  • Patient who does not use or refuses to take any appropriate contraceptive measures (intrauterine contraceptive ring, barrier contraception combined with spermicidal gel or sterilization operation), including women of childbearing age (within 2 years after the last menstrual period) and men who are with possible fertility.
  • Unable or unwilling to comply with the research plan.
  • The existence of any other disease, dysfunction caused by metastatic lesions, or suspicious disease found on the regular examination, which indicating contraindications to the use of study drugs or may bring high risks of treatment related complications

Trial locations and contacts

1 site in 1 country.

China1 site

  • Sun Yat-sen University Cancer Center

    Guangzhou, Guangdong, 510060

Other trials in China

About this study

Official title: FUDR/Oxaliplatin HAI Plus Irinotecan Chemotherapy vs. FOLFOXIRI Chemotherapy in Treating Initially Unresectable CRCLM

The aim of the trial is to compare the objective response rates of FUDR/Oxaliplatin HAI plus CPT-11 and FOLFOXIRI chemotherapy in patients with initially non-resectable metastatic colorectal cancer liver metastases. The patients will be treated with systemic FOLFOXIRI chemotherapy or FUDR/Oxaliplatin hepatic arterial infusion with CPT-11 systemic chemotherapy.

Read the detailed description

Previous studies and our experience have proved the efficacy and safety of systemic chemotherapy combined with hepatic arterial infusion (HAI) with floxuridine and dexamethasone in patients with initially unresectable colorectal liver metastasis. Hepatic arterial infusion oxaliplatin trials have been done with oxaliplatin alone and in combination with irinotecan, 5-FU/LV, and mitomycin-C and have showed that Hepatic arterial infusion oxaliplatin and FUDR could increase response rate and resection rate for colorectal liver metastasis. Therefore, we designed this study to compare objective response rates of FUDR/Oxaliplatin HAI plus CPT-11 and FOLFOXIRI chemotherapy in patients with initially non-resectable metastatic colorectal cancer liver metastases.

Being tested
Irinotecan, Oxaliplatin HAI, Floxuridine, Leucovorin, 5-FU
Medical subject headings
Colorectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • IrinotecanDrug

    Irinotecan 150 mg/m2 IV over 90 minutes on Day 1 and 15.

  • Oxaliplatin HAIDrug

    Oxaliplatin 85 mg/m2 over 3 hours will be administered through the HAI pump on day 1. Oxaliplatin 85 mg/m2 IV over 3 hours on day 15.

  • FloxuridineDrug

    0.12 mg/kg/day floxuridine (FUDR) and 25 mg dexamethasone in normal saline to a total volume of 300 ml will be administered through the HAI pump.

  • LeucovorinDrug

    Leucovorin 200mg/m2 IV on Day 1 and 15.

  • 5-FUDrug

    5-FU 2400mg/m2 CIV in 46h on Day 1 and 15.

  • OxaliplatinDrug

    Oxaliplatin 85 mg/m2 IV over 3 hours on Day1 and 15.

Study groups in NCT03678428
Study groupRoleWhat they receive
FUDR/Oxaliplatin HAI plus irinotecanExperimentalPatients will receive Systemic CPT-11 + HAI (FUDR+L-OHP) every 28 days: Irinotecan 150 mg/m2 IV over 90 minutes on Day 1; followed by Oxaliplatin 85 mg/m2 over 3 hours through the HAI pump on Day 1 and 0.12 mg/kg/day floxuridine (FUDR) and 25 mg dexamethasone in normal saline to a total volume of 300 ml will be administered through the HAI pump. then Irinotecan 150 mg/m2 IV over 90 minutes on Day 15, followed by Oxaliplatin 85 mg/m2 IV over 3 hours on Day 15. This will be repeated on Day 1 of each 28-day cycle. FUDR will be administered through a 14-day continuous infusion with the HAI pump.
Receives: Drug: Irinotecan; Drug: Oxaliplatin HAI; Drug: Floxuridine
FOLFOXIRIActive comparatorPatients will receive Systemic FOLFOXIRI every 28 days: Irinotecan 150 mg/m2 IV over 90 minutes on Day 1 and Day 15; Oxaliplatin 85 mg/m2 IV in 3-6 hours on Day 1 and Day 15; Leucovorin 200mg/m2 and 5-FU 2400mg/m2 CIV in 46 hours on Day 1 and Day 15.
Receives: Drug: Irinotecan; Drug: Leucovorin; Drug: 5-FU; Drug: Oxaliplatin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall Response Rate and bilateral 95% confidence interval

    defined as complete remission rates and partial remission rates after treatment.

    Measured: Up to 2-4 months

Secondary outcomes (6)

  1. R0 resection rates

    defined as no macroscopic or microscopic residual tumor

    Measured: Up to 2-4 months

  2. Depth of tumor regression(DpR)

    defined as the largest depth of tumor regression

    Measured: Up to 2-4 months

  3. Progress-free Survival(PFS)

    defined as the period from the date of receiving treatment to disease progress caused by any reason.

    Measured: Up to 2-4 months

  4. Relapse-free Survival(RFS) of patients with resectable tumor

    defined as the period from the date of resection to tumor relapse caused by any reason.

    Measured: Up to 2-4 months

  5. Overall Survival(OS)

    defined as the period from the date of receiving treatment to death caused by any reason.

    Measured: Up to 2-4 months

  6. Adverse events, servere adverse events and surgery-related adverse events rates

    defined as the incidence and severity of adverse events related to chemotherapy, HAI and surgery.

    Measured: Up to 2-4 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Sep 2018
  2. Study start31 Dec 2021
  3. Primary completion31 Oct 2022
  4. Study completion31 Dec 2022

Why it stopped: Production halt of FUDR in China

Resources

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
92 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03678428
Sponsor's protocol ID
TRIUMPH
Status last verified
Feb 2023
First submitted
18 Sep 2018
Last updated
16 Feb 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Irinotecan, Oxaliplatin HAI and Floxuridine in people with Metastatic Colorectal Cancer and Liver Metastases, run by Sun Yat-sen 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 16 inclusion and 15 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: stopped early, as of the sponsor's last update on 16 Feb 2023. 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 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?

The study was stopped early (reason given: Production halt of FUDR in China). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Response Rate and bilateral 95% confidence interval (time frame: Up to 2-4 months). 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 NCT03678428.

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 Feb 2023.

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