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

NCT02529774 · Status: UNKNOWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 432

Last updated 2015-08-20

No results posted yet for this study

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.

Conditions

  • Resected Liver Metastases From Colorectal Cancer

Interventions

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

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

Sponsors & Collaborators

  • Ye Xu

    lead OTHER

Principal Investigators

  • Ye Xu, Dr. · Fudan University Shanghai Cancer Center China

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-09-30
Primary Completion
2020-09-30
Completion
2021-09-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02529774 on ClinicalTrials.gov