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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

360 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-10-11

Study Completion Date

2019-09-11

Brief Summary

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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).

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Detailed Description

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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.

Conditions

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Colorectal Cancer Liver Metastasis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Raltitrexed-based chemotherapy

Raltitrexed plus Oxaliplatin/Raltitrexed plus Irinotecan

Group Type EXPERIMENTAL

Raltitrexed-based chemotherapy

Intervention Type DRUG

Raltitrexed: 2.0mg,iv,15min,d1,Oxaliplatin:85mg/m2 iv,d1, q2w

Raltitrexed-based chemotherapy

Intervention Type DRUG

Raltitrexed: 2.0mg,iv,15min,d1,Irinotecan:180mg/m2 iv,d1, q2w

5-fluorouracil-based chemotherapy

5-fluorouracil plus Oxaliplatin/5-fluorouracil plus Irinotecan

Group Type ACTIVE_COMPARATOR

5-fluorouracil-based chemotherapy

Intervention Type DRUG

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

Intervention Type DRUG

5-fluorouracil: 400mg/m2,ivp,2h,d1,1200mg/m2/d\*2d(2400mg/m2,iv46-48h); Irinotecan:180mg/m2 d1, iv,q2w

Interventions

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Raltitrexed-based chemotherapy

Raltitrexed: 2.0mg,iv,15min,d1,Oxaliplatin:85mg/m2 iv,d1, q2w

Intervention Type DRUG

Raltitrexed-based chemotherapy

Raltitrexed: 2.0mg,iv,15min,d1,Irinotecan:180mg/m2 iv,d1, q2w

Intervention Type DRUG

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

Intervention Type DRUG

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

Intervention Type DRUG

Other Intervention Names

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RTXOX RTXIRI mFOLFOX6 FOLFIRI

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No