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Systemic Chemotherapy Plus HAI(FUDR）vs Systemic Chemotherapy Alone For CRCLM

Sponsor
Sun Yat-sen University (Other)
Overall Status
Recruiting
CT.gov ID
NCT03500874
Collaborator
(none)
288
Enrollment
1
Location
2
Arms
82.1
Anticipated Duration (Months)
3.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The aim of the trial is to optimize the overall survival of patients with resectable colorectal liver metastasis who have undergone liver metastasis resection. The patients will be treated with systemic chemotherapy plus hepatic arterial infusion With floxuridine, or with systemic chemotherapy only

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Anticipated Enrollment :
288 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Systemic Chemotherapy Plus HAI(FUDR）vs Systemic Chemotherapy Alone As Adjuvant Therapy in Patients With Resectable Colorectal Liver Metastasis
Actual Study Start Date :
Feb 28, 2018
Anticipated Primary Completion Date :
Dec 31, 2020
Anticipated Study Completion Date :
Dec 31, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Systematic Chemotherapy + HAI(FUDR)

Patients will receive Systemic FOLFOX + HAI (FUDR) every 28 days: Oxaliplatin 85 mg/m2 ivd over 3 hours on Day 1,15; Leucovorin (l-LV) 200mg/m2 ivd over 2 hours on Day 1,15; followed by 5-Fluorouracil 2.4 g/m2 for 46 hours continuous infusion on Day 1,15. floxuridine (FUDR) 0.12mg/Kg/d,d1-14 and 25 mg dexamethasone in normal saline to a total volume of 300 ml will be administered through the HAI pump. 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.

Drug: FUDR
Floxuridine(FUDR) 0.12 mg/kg/day，on Day 1-14 through the HAI pump.
Other Names:
  • Floxuridine

    • Drug: Oxaliplatin
    Oxaliplatin 180 mg/m2 IV over 90 minutes on Day 1, 15.

    Drug: Leucovorin
    Leucovorin 200mg/m2 ivd over 2 hours on Day 1

    Drug: 5FU
    followed by 5-Fluorouracil 2.4 g/m2 for 46 hours continuous infusion on Day 1.
    Other Names:
  • 5-Fluorouracil

    		•
    Active Comparator: Systematic Chemotherapy

    Patients will receive FOLFOX every every 28 days: Oxaliplatin 85 mg/m2 ivd over 3 hours on Day 1,15; Leucovorin (l-LV) 200mg/m2 ivd over 2 hours on Day 1,15; followed by 5-Fluorouracil 2.4 g/m2 for 46 hours continuous infusion on Day 1,15.

    Drug: Oxaliplatin
    Oxaliplatin 180 mg/m2 IV over 90 minutes on Day 1, 15.

    Drug: Leucovorin
    Leucovorin 200mg/m2 ivd over 2 hours on Day 1

    Drug: 5FU
    followed by 5-Fluorouracil 2.4 g/m2 for 46 hours continuous infusion on Day 1.
    Other Names:
  • 5-Fluorouracil

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 3 Year Relapse Free Survival Rate [up to 36 monthes]

      From the date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 monthes

    Secondary Outcome Measures

    1. Overall Survival [up to 4 years]

      From date of randomization until the date of death from any cause, assessed up to 4 years

    Other Outcome Measures

    1. Toxicity [Up to 6 monthes]

      number of patients with adverse events and severity according to NCI CTC 3.0

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. Age: 18-75 years old

    2. Histologically confirmed colorectal adenocarcinoma

    3. Radiologically or pathologically confirmed diagnosis of colorectal liver metastasis

    4. besides systematic chemotherapy，with no prior treatment for liver metastasis, including operation, radiotherapy,HAI, transcatheter hepatic arterial chemoembolization (TACE) and ablation.

    5. Without extra-hepatic metastasis confirmed by CT, MRI or PET/CT (if necessary) scanning

    6. With adequate bone marrow function: platelets ≥ 90 x 109/L; white blood cells ≥ 3×109/L; absolute neutrophil count (ANC) ≥ 1.5 x 109/L Serum bilirubin ≤ 1.5 x ULN, AST and ALT ≤ 5 x ULN

    7. Patient has no ascites and with adequate blood coagulation function, albumin ≥ 35 g/L

    8. Grade A level of Child-Push Liver Function

    9. Creatinine ≤ 1× ULN, or Calculated Creatinine Clearance >50ml/min （Cockcroft-Gault Equation）

    10. ECOG performance status of 0-2

    11. Life expectancy ≥ 3 months

    12. Not appropriate for anti-EGFR or any other targeted therapy (with KRAS mutation or could not afford it)

    13. Patients have provided a signed Informed Consent Form

    14. With good compliance

    Exclusion Criteria:

    1. With any extra-hepatic metastasis and/or primary tumor recurrence

    2. Severe arterial embolism or ascites

    3. With hemorrhagic tendency or coagulation disorders

    4. Hypertensive crisis or hypertensive encephalopathy

    5. Severe and uncontrolled systemic complications such as infections or diabetes.

    6. Serious cardiovascular diseases such as cerebrovascular accident (within 6 months before enrollment), myocardial infarction (within 6 months before enrollment), uncontrolled hypertension even with appropriate drug intervention, unstable angina pectoris, congestive heart failure (NYHA 2-4 degree), arrhythmia that needs medication intervention

    7. Patient who has suffered from central nervous system diseases such as primary brain tumor, uncontrolled epilepsy even with standard treatment, any brain metastasis or stroke

    8. Patient who has a concurrent malignancy or has a malignancy within 5 years before study enrollment, (with the exception of radically resected skin basal cell carcinoma or cervical carcinoma in situ)

    9. Patient who has received any investigational antineoplastic agent within 28 days before the enrollment

    10. Any residual toxicity from prior chemotherapy (with the exception of alopecia), such as grade 2 or more sensory peripheral neuropathy (NCI CTC v3.0), oxaliplatin-based regimen will not be considered

    11. Patient who is allergic to oxaliplatin, leucovorin, 5-Fluorouracil, floxuridine or dexamethasone

    12. Pregnant or lactating women

    13. 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

    14. Unable or unwilling to comply with the research plan

    15. 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Sun Yat-sen University Cancer Center Guangzhou Guangdong China 510060

    Sponsors and Collaborators

    • Sun Yat-sen University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Yuhong Li, Professor, Sun Yat-sen University
    ClinicalTrials.gov Identifier:
    NCT03500874
    Other Study ID Numbers:
    • HAI-CRCLM-ADJUVANT
    First Posted:
    Apr 18, 2018
    Last Update Posted:
    Oct 29, 2019
    Last Verified:
    Oct 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Neoplasm Metastasis
    Leucovorin
    Fluorouracil
    Floxuridine
    Oxaliplatin

    Study Results

    No Results Posted as of Oct 29, 2019