Compare Efficacy and Safety of Raltitrexed-based and 5fu-based Neoadjuvant Chemotherapy for Colorectal Liver Metastasis

Colorectal Cancer Clinical Trial

Official title:

The Second Affiliated Hospital of Zhejiang University

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02453490
• Other study ID #: CRCLM-01
• Status: Terminated
• Phase: Phase 3
• Start date: October 11, 2015
• Est. completion date: September 11, 2019

Study information

• Verified date: July 2020
• Source: Zhejiang University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 360
• Est. completion date: September 11, 2019
• Est. primary completion date: September 11, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms
• Liver Metastasis
• Liver Neoplasms
• Neoplasm Metastasis

Intervention

Drug:
• Raltitrexed-based chemotherapy
Raltitrexed: 2.0mg,iv,15min,d1,Oxaliplatin:85mg/m2 iv,d1, q2w
• Raltitrexed-based chemotherapy
Raltitrexed: 2.0mg,iv,15min,d1,Irinotecan:180mg/m2 iv,d1, q2w
• 5-fluorouracil-based chemotherapy
5-fluorouracil:400mg/m2,ivp,2h,d1,1200mg/m2/d*2d(2400mg/m2,iv46-48h); Oxaliplatin:85mg/m2 iv,d1,q2w
• 5-fluorouracil-based chemotherapy
5-fluorouracil: 400mg/m2,ivp,2h,d1,1200mg/m2/d*2d(2400mg/m2,iv46-48h); Irinotecan:180mg/m2 d1, iv,q2w

Locations

Country	Name	City	State
China	The Affiliated Tumor Hospital of Zhongshan University	Guangzhou	Guangdong
China	Second Affiliated Hospitalof Zhejiang University School of Medicine	Hangzhou	Zhejiang
China	Sir Run Run Shaw Hospital, Zhejiang University School of Medicine	Hangzhou	Zhejiang
China	The First Affiliated Hospital of College of Medicine Zhejiang University	Hangzhou	Zhejiang
China	Jinhua People's Hospital	Jinhua	Zhejiang
China	The second hospital of Ningbo City	Ningbo	Zhejiang
China	Changhai Hospital of Shanghai	Shanghai	Shanghai
China	Wuhan Union Hospital	Wuhan	Hubei
China	Zhongnan Hospital Affiliated to Wuhan University	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	The side effects of the treatment		38 months
Other	The early tumor shrinkage (ETS)and depth of response(DPR)		38 months
Primary	Objective response rate		38 months
Secondary	R0 resection rate of liver		38 months