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Alternating Systemic and Hepatic Artery Infusion Therapy As Adjuvant Treatment After Resection of Liver Metastases From Colorectal Cancer

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ClinicalTrials.gov Identifier: NCT02529774
Recruitment Status : Not yet recruiting
First Posted : August 20, 2015
Last Update Posted : August 20, 2015
Sponsor:
Information provided by (Responsible Party):
Ye Xu, Fudan University

Brief 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.

Condition or disease Intervention/treatment Phase
Resected Liver Metastases From Colorectal Cancer Drug: Floxuridine (FUDR),Dexamethasone (DXM), Heparin in combination with Oxaliplatin and Capecitabine (CapeOX) or in combination with Oxaliplatin and Leucovorin and 5-FU (mFOLFOX6) Drug: Oxaliplatin and Capecitabine (CapeOX) or Oxaliplatin and Leucovorin and 5-FU (mFOLFOX6) Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 432 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : September 2015
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : September 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Systemic Chemotherapy plus Hepatic Artery Infusion (HAI) Drug: 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


Active Comparator: Systemic Chemotherapy Drug: 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





Primary Outcome Measures :
  1. 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

  2. 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.


Secondary Outcome Measures :
  1. Disease free survival [ Time Frame: 3-year ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02529774


Contacts
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Contact: Ye Xu, Dr. +86 21 64175590 xu_shirley021@163.com
Contact: Hongtu Zheng, Dr. +86 180 1731 7711 zht5863@126.com

Locations
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China, Shanghai
Fudan University Shanghai Cancer Center China Not yet recruiting
Shanghai, Shanghai, China, 200032
Contact: Ye Xu, Dr.    +86 21 64175590    xu_shirley021@163.com   
Contact: Hongtu Zheng, Dr.    +86 180 1731 7711    zht5863@126.com   
Sponsors and Collaborators
Ye Xu
Investigators
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Principal Investigator: Ye Xu, Dr. Fudan University Shanghai Cancer Center China

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Responsible Party: Ye Xu, Professor, Fudan University
ClinicalTrials.gov Identifier: NCT02529774     History of Changes
Other Study ID Numbers: 1507149-6
First Posted: August 20, 2015    Key Record Dates
Last Update Posted: August 20, 2015
Last Verified: August 2015

Additional relevant MeSH terms:
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Colorectal Neoplasms
Neoplasm Metastasis
Liver Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Colonic Diseases
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases
Neoplastic Processes
Pathologic Processes
Liver Diseases
Dexamethasone
Capecitabine
Oxaliplatin
Fluorouracil
Floxuridine
Heparin
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones