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

NCT ID: NCT02529774

Last Updated: 2015-08-20

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 432 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-09-30
• Study Completion Date: 2021-09-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Systemic Chemotherapy plus Hepatic Artery Infusion (HAI)

Group Type: EXPERIMENTAL

Floxuridine (FUDR),Dexamethasone (DXM), Heparin in combination with Oxaliplatin and Capecitabine (CapeOX) or in combination with Oxaliplatin and Leucovorin and 5-FU (mFOLFOX6)

Intervention Type: 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

Group Type: ACTIVE_COMPARATOR

Oxaliplatin and Capecitabine (CapeOX) or Oxaliplatin and Leucovorin and 5-FU (mFOLFOX6)

Intervention Type: 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

Interventions

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

Intervention Type: 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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ye Xu

OTHER

Sponsor Role: lead

Responsible Party

Ye Xu

Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Ye Xu, Dr.

Role: PRINCIPAL_INVESTIGATOR

Fudan University Shanghai Cancer Center China

Locations

Fudan University Shanghai Cancer Center China

Shanghai, Shanghai Municipality, China

Countries

China

Central Contacts

Ye Xu, Dr.

Role: CONTACT

xu_shirley021@163.com

+86 21 64175590

Hongtu Zheng, Dr.

Role: CONTACT

zht5863@126.com

+86 180 1731 7711

Facility Contacts

Ye Xu, Dr.

Role: primary

xu_shirley021@163.com

+86 21 64175590

Hongtu Zheng, Dr.

Role: backup

zht5863@126.com

+86 180 1731 7711

Other Identifiers

1507149-6

Identifier Type: -

Identifier Source: org_study_id