Clinical trial NCT02453490: Compare Efficacy and Safety of Raltitrexed-based and 5fu-based Neoadjuvant Chemotherapy for Colorectal Liver Metastasis
Official title: The Second Affiliated Hospital of Zhejiang University
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Colorectal Cancer
Liver Metastasis
Keywords: Colorectal Cancer
liver metastasis
neoadjuvant chemotherapy
Lead sponsor: Zhejiang University
Sponsor class: OTHER
First posted: 2015-05-25
Enrollment: 360
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is a multicenter ,randomization, open control study to evaluate the efficacy and safety of Raltitrexed-based chemotherapy and 5-fluorouracil-based chemotherapy in the peri-operative treatment of patients with Liver Metastasis From colorectal cancer (CRC).

Detailed description: The contrast analysis is separately done on Raltitrexed plus oxaliplatin and 5-fluorouracil plus oxaliplatin;Raltitrexed plus irinotecan and 5-fluorouracil plus irinotecan.To investigate the objective response rate,the R0 resection rate, the early tumor shrinkage （ETS）and depth of response(DPR) and the safety profile.

Eligibility criteria: Inclusion Criteria:

1. Histologically confirmed chinese colorectal cancer patients and imaging detection confirmed liver metastasis
2. previously no treatment for liver metastasis or Primary tumor had been removed and last additional chemotherapy over one year
3. Age of≥18 and ≤75
4. Adequate organ functions, as determined by normal bone marrow function (absolute neutrophil count2 x 109/L, platelets 100 x 109/L, White blood cells 4 x 109/L), liver function (serum bilirubin ≤ 2.5 x ULN, serum transaminases ≤2. 5x ULN)
5. ECOG≤1
6. Life Expectancy\>6months
7. Signed written informed consent
8. Expected adequacy of follow-up

Exclusion Criteria:

1. Lesion is too small to assess by imaging
2. Extrahepatic metastases
3. Any anticancer chemotherapy in development within 4 weeks prior to study entry
4. Concurrent uncontrolled illness such as infection
5. Be allergic to medicines in the study
6. Pregnant or nursing patients
7. Fertile women (\< 2 years after last menstruation) and men of childbearing potential not willing to use effective means of contraception.
8. Not willing or incapable to comply with all study visits and assessments
9. Evidence of any other disease, metabolic dysfunction, physical examination finding or laboratory finding giving reasonable suspicion of a disease or condition that puts the patient at high risk for treatment-related complications.

Primary outcomes:
measure: Objective response rate
timeFrame: 38 months
Secondary outcomes:
measure: R0 resection rate of liver
timeFrame: 38 months
Other outcomes:
measure: The side effects of the treatment
timeFrame: 38 months
measure: The early tumor shrinkage （ETS）and depth of response(DPR)
timeFrame: 38 months
Locations:
city: Guangzhou
country: China
facility: The Affiliated Tumor Hospital of Zhongshan University
state: Guangdong
city: Wuhan
country: China
facility: Wuhan Union Hospital
state: Hubei
city: Wuhan
country: China
facility: Zhongnan Hospital Affiliated to Wuhan University
state: Hubei
city: Shanghai
country: China
facility: Changhai Hospital of Shanghai
state: Shanghai
city: Hangzhou
country: China
facility: The First Affiliated Hospital of College of Medicine Zhejiang University
state: Zhejiang
city: Hangzhou
country: China
facility: Second Affiliated Hospitalof Zhejiang University School of Medicine
state: Zhejiang
city: Hangzhou
country: China
facility: Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
state: Zhejiang
city: Jinhua
country: China
facility: Jinhua People's Hospital
state: Zhejiang
city: Ningbo
country: China
facility: The second hospital of Ningbo City
state: Zhejiang
Study officials:
affiliation: Zhejiang University
name: Ding Ke-Feng, PHD/MD
role: STUDY_CHAIR
References: