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

NCT02529774 | Unknown Phase 2 DMC

• 1 other identifier: 1507149-6
• Study Type: interventional
• Target: 432
• Locations: 1 country
• Sites: 1

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.

Conditions

Resected Liver Metastases From Colorectal Cancer

Outcome Measures

Primary Outcomes (2)

• Overall Survival

  Overall survival will be measured from the date of randomization up to the date of death of any cause

  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.

  3-year

Secondary Outcomes (1)

• Disease free survival

  3-year

Study Arms (2)

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)

Interventions

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

Systemic Chemotherapy plus Hepatic Artery Infusion (HAI)

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

Systemic Chemotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• Ye Xu: lead

Study Sites (1)

Fudan University Shanghai Cancer Center China

Shanghai, Shanghai Municipality, 200032, China

Location

MeSH Terms

Interventions

Floxuridine; Heparin; Oxaliplatin; Capecitabine; Leucovorin; Fluorouracil

Intervention Hierarchy (Ancestors)

Deoxyuridine; Uridine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Glycosaminoglycans; Polysaccharides; Carbohydrates; Coordination Complexes; Organic Chemicals; Deoxycytidine; Cytidine; Uracil; Pyrimidinones; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Coenzymes; Enzymes and Coenzymes

Study Officials

• Ye Xu, Dr.

  Fudan University Shanghai Cancer Center China

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ye Xu, Dr.

CONTACT

+86 21 64175590; xu_shirley021@163.com

Hongtu Zheng, Dr.

CONTACT

+86 180 1731 7711; zht5863@126.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 18, 2015
• First Posted: August 20, 2015
• Study Start: September 1, 2015
• Primary Completion: September 1, 2020
• Study Completion: September 1, 2021
• Last Updated: August 20, 2015

Record last verified: 2015-08

Locations

CN (1)